Guidance library
UK temperature guidance, in one place
258 questions on storing, monitoring and moving medicines and vaccines, each answered from the official source: UK legislation, RPS, NHS SPS, WHO, European Commission and more. Filter by your setting, the topic, or how binding it is.
By setting
What applies where you work
Start with your setting: each page explains the rules that apply to you, then answers the questions people ask.
Care homes
What NICE, CQC, SPS and the RPS say about storing medicines in care homes: the medicines fridge, room temperature, records and what to do when it goes wrong.
27 questionsHospitals and wards
Ward fridges, treatment rooms that run warm, weekend checks and who acts on an alarm: the guidance for hospitals and hospital pharmacy.
47 questionsGP practices
What CQC, UKHSA and the Green Book expect of a practice: the vaccine fridge, the twice-checked thermometer, records and the cold chain to clinics.
72 questionsCommunity pharmacy
Vaccine and medicines fridges, room temperature, records and excursions for registered pharmacies, from the GPhC, RPS, UKHSA and SPS.
59 questionsWholesalers (WDA)
What WDA holders and Responsible Persons must show: mapped stores, calibrated monitoring, alarms, qualified transport and records, from the MHRA and the GDP guidelines.
80 questionsManufacturers (GMP)
What EU GMP, the Orange Guide, Annex 15, Annex 1 and ICH Q1A ask of stores, cold rooms, stability chambers, QC fridges and freezers, and how to evidence it.
52 questions
By topic
Read one subject end to end
Vaccine fridges
The Green Book, the UKHSA protocol, CQC and NHS SPS on storing vaccines at +2 °C to +8 °C: the fridge, the readings, the records and what to do when it goes wrong.
55 questionsFridges and room storage
Domestic or pharmaceutical fridge, where to put it, how full to fill it, and what the guidance says about rooms and cupboards that run warm.
47 questionsTemperature excursions
What the MHRA, UKHSA and SPS expect when a fridge, store or vehicle goes out of range: quarantine, assess, ask the manufacturer, record and report.
60 questionsMapping and qualification
When to map, how often to repeat it, where the probes go and what the MHRA, EU GDP and WHO guidance say about qualifying stores, fridges and vehicles.
45 questionsMonitoring, alarms and calibration
Min/max thermometers or data loggers, how often to read them, who the alarm reaches and how often the instruments must be calibrated.
92 questionsRecords and data integrity
How long to keep fridge records, whether a printout is enough, and what the MHRA's data integrity guidance means for electronic monitoring systems.
50 questionsCold chain transport
Vehicles, cool boxes, couriers, off-site clinics and home visits: what GDP, UKHSA and SPS guidance say about keeping temperature in transit and proving it.
42 questionsPower failures and contingency
What to do when the power goes or a fridge fails, out of hours alarms, and what the guidance expects in your contingency plan.
19 questionsResponsibility and inspection
Named leads, Responsible Persons, procedures and training, and the temperature findings that come up most often at MHRA and CQC inspections.
62 questions
Going further
Conflicts, regulators and draft rules
How long to keep records
Retention periods for UK and Irish settings, from 5 years for GDP to 30 years for blood traceability, verified against the source. Also as a PDF.
See the tableEU GMP and the Orange Guide
For manufacturers: storage, calibration, Annex 15 mapping and requalification, stability chambers, Annex 1 and retention, clause by clause.
Read the guideAnnex 11 and Annex 22 drafts
The 2025 EU GMP drafts on computerised systems, SaaS suppliers and AI, in short sourced points. Drafts, not yet adopted.
Read the key pointsWhere the guidance disagrees
Conflicts and gaps between the official sources, side by side, with a risk-based way to decide.
See the casesMHRA and HPRA
One GDP standard, two regulators: where the published emphasis differs between Great Britain and Ireland.
CompareJustifying probe locations
How to show why each monitoring probe is where it is, from your mapping study, with a worked example and a template.
Read the guideBlood product simulants
Water, glycerol or a validated block for the blood fridge product probe: what BS 4376 says, what one hospital found, and how to test your own.
Read the guideEN 12830 and independent monitoring
The temperature recorder standard almost nobody mentions: law for quick-frozen food, a benchmark for medicines and blood, and why monitoring must be independent of control.
Read the guide
Looking for food? See food guidance.
Every question
Ask it the way you'd ask a colleague
All 258 questions and answers in one list. Search them, or narrow them by setting, topic or how binding the source is. Where the sources disagree or leave room for judgement, the answer says so.
Law: A legal requirement: statute or regulation.
Formal guidance: Published guidance an inspector expects you to follow or to justify departing from.
Interpretation: How the regulator or a professional body reads the rules: blogs, Q&As, mythbusters, inspection findings.
Is temperature control of veterinary medicines a legal requirement or just good practice?Law
It is a legal requirement. Schedule 3 paragraph 3E of the Veterinary Medicines Regulations 2013 requires a retailer of veterinary medicinal products to store them, including during transport, in line with any specific label instructions and the summary of product characteristics. It was inserted by the Veterinary Medicines (Amendment etc.) Regulations 2024 with effect from 17 May 2024 in England, Wales and Scotland. The VMD says it covers all categories, including POM-V, POM-VPS, NFA-VPS and AVM-GSL.
What's agreed, and what isn't
The regulation sets the outcome (store as per SPC) and does not prescribe monitoring methods. Those come from VMD inspector guidance and the RCVS Practice Standards Scheme. The 2024 amendment's territorial extent should be checked for Northern Ireland.
What storage temperatures does UK law set for red cells, platelets and granulocytes?Law
Part 4 of the Schedule to the Blood Safety and Quality Regulations 2005 sets liquid storage at +2 to +6°C for red cell preparations and whole blood (28 to 49 days depending on process), +20 to +24°C for platelets (5 days, or 7 with bacterial detection or reduction) and +20 to +24°C for granulocytes (24 hours). It also says transport and distribution at every stage of the transfusion chain must maintain product integrity. Regulation 7 requires blood establishments to comply with Part 4.
What's agreed, and what isn't
The Regulations give cryopreservation durations (for example plasma and cryoprecipitate up to 36 months) but no frozen storage temperature; the -25°C figure for FFP comes from the JPAC Red Book. Transport has no numeric range in law, only the integrity requirement.
Can we keep staff milk or specimens in the medicines fridge, and does it need a lock?Guidance
No. RPS says fridges and freezers used for medicines must not store other items, should be locked when not in use, and must be protected from accidental switch-off. They should not be overloaded, and medicines should not touch the sides or base, so that air can circulate. SPS, the NHS Pharmaceutical QA Committee and the SW ICARS toolkit all say the same about food and specimens.
What's agreed, and what isn't
Locking can be met by a lockable fridge or a locked room, as the SW ICARS toolkit notes for vaccine fridges.
Can we use a domestic fridge to store medicines in a care home or GP practice?Guidance
SPS says domestic fridges and freezers are not recommended for storing medicines in healthcare settings, and that cold chain medicines should be kept in a specialist medicines fridge or freezer. Medicines fridges use fan cooling and have no ice box or salad drawer, so the temperature is more even. SPS also says not to use a laboratory fridge. The NHS Pharmaceutical QA Committee warns that parts of a domestic fridge can routinely drop below freezing.
What's agreed, and what isn't
The SPS article does not mention care homes, and "not recommended" is guidance, not a legal ban. In care homes, a resident's few fridge items have sometimes been kept in a lockable domestic-style fridge. SPS gives no exemption for this, and local ICB or CQC expectations should be checked. The NHS England SW ICARS toolkit is firmer for vaccines: "Do not use a domestic fridge."
Do we need to temperature map a pharmaceutical fridge, and can a household fridge be used?Guidance
WHO model guidance says refrigerators and freezers should be purpose-designed, and household-style units are acceptable only if independently tested against a recognised standard for pharmaceutical refrigerators. It says qualification may not be needed for equipment with little or no site assembly that has been independently tested, provided it is installed correctly. WHO's mapping supplement explicitly does not cover refrigerators or freezers, because they are generally tested and prequalified independently.
What's agreed, and what isn't
WHO's later Good Storage and Distribution Practices guideline (TRS 1025, Annex 7, 2020) lists refrigerators and freezers among the places where mapping should be done, which conflicts with Supplement 8. Follow your inspector's or sector guidance, and document why you did or did not map.
Does in-use insulin for a self-administering patient on the ward need to stay in the fridge?Guidance
SPS's self-administration guidance says in-use insulin does not require refrigeration. It can be kept with the patient's other medicines, or outside secure storage after a local risk assessment. Some medicines, such as reliever inhalers, GTN spray and insulin, may be exempt from locked storage, subject to risk assessment.
What's agreed, and what isn't
Unopened insulin stock still needs 2-8 °C. In-use storage limits, such as days at room temperature and maximum temperature, are product-specific in the SmPC.
During a heatwave, what should we tell patients or care staff about storing insulin, inhalers and auto-injectors?Guidance
SPS repeats MHRA advice to store medicines somewhere cool, dry and out of direct sunlight. Insulin should be kept in a fridge or a cool bag, and replaced if blood glucose is unexpectedly high in case heat has damaged it. Inhalers should not be left in parked cars, because heat can damage them or make pressurised inhalers burst. Adrenaline auto-injectors should be checked for damage or discolouration. In anaphylaxis, use of an auto-injector should not be delayed because of possible heat exposure if no alternative is to hand.
What's agreed, and what isn't
This page covers patient risk rather than stock storage. It does not give stockroom or care home room-temperature limits.
How must retention and reference samples be stored, and for how long?Guidance
The revised Annex 19 (applicable from 24 September 2026) says reference and retention samples of each finished product batch should be kept for at least one year after the expiry date (3.1), stored in line with the guidance on declaration of storage conditions (5.1) and the marketing authorisation, for example refrigerated where relevant (5.2).
What's agreed, and what isn't
MHRA's 2015 GMP deficiency examples include a retention sample store with no temperature logger nearby, and a site with no storage facilities, monitoring devices or procedures for its reference and retention samples. The sample store is often the least watched room on site.
How often should a medicines fridge be serviced, and what routine cleaning is expected?Guidance
SPS says a refrigeration specialist should service and calibrate fridges annually, and that portable appliance testing should follow local policy. Routine care includes wiping door seals and checking them for damage, clearing the drain hole, and dusting accessible condenser coils. Freezers should be defrosted when ice builds up. Cleaning frequency is set locally.
What's agreed, and what isn't
SPS also recommends end-of-shift checklists to confirm the fridge is switched on and in range, but does not say which role does them. The NHS England SW ICARS toolkit asks GP practices to keep the maintenance log with the vaccine fridge.
How should a medicines fridge be set up and loaded?Guidance
SPS recommends running fridges at 2-8 °C, with 5 °C as a typical mid-point set point. Leave clearance on all sides away from heat sources, and level the feet so the door swings shut if left ajar. Protect the unit from being switched off by accident, for example with a socket guard or fixed spur. Do not overfill it, because pharmacy fridges rely on chilled air moving around the chamber. Keep stock off the walls and base, and use mesh baskets rather than solid trays or polystyrene.
What's agreed, and what isn't
SPS accepts brief excursions during stock handling if the temperature recovers quickly. Anything else goes through the excursion process.
How should platelets be stored, and what happens if the agitator stops?Guidance
Platelets are stored at a core temperature of 22 ±2°C with continuous gentle agitation, for up to 5 days in a closed system (7 days only with bacterial screening or pathogen inactivation). If agitation is interrupted, for example by equipment failure or long transport, the platelets keep the same shelf life as long as no single interruption lasts more than 8 hours and all interruptions total no more than 24 hours. Transport containers should be equilibrated at room temperature, and on receipt the platelets go back to 22 ±2°C storage with agitation.
What's agreed, and what isn't
Platelets need controlled room-temperature storage, not a fridge. Monitoring of the incubator or agitator, and of room temperature where open shelving is used, is implied but not specified.
Is there official hot-weather guidance saying medicines must be kept below 25 °C?Guidance
UKHSA's hot weather guidance for healthcare professionals says "Most medicines should be kept below 25°C", somewhere cool and dry, away from direct sunlight and windowsills. It also says medicines should only go in the fridge if their labelling specifies it, and refers readers to SPS for more detail on medicines storage.
What's agreed, and what isn't
The NHS England Heatwave Plan has been replaced by UKHSA's Adverse Weather and Health Plan. The 25 °C figure is a general rule: the pack or SmPC decides, and some products allow 30 °C. Putting ambient medicines in the fridge to cool them is discouraged unless the labelling allows it. SPS permits creams, ointments and suppositories only after checking with a pharmacist.
We make an API. What does GMP Part II say about storage temperature?Guidance
Part II (ICH Q7) says materials should be stored under conditions and for a period that do not adversely affect their quality (7.42). Storage facilities should hold materials under appropriate conditions, for example controlled temperature and humidity when necessary, and records should be kept of those conditions "if they are critical for the maintenance of material characteristics" (10.10). Utilities that could affect quality, such as HVAC, should be qualified and monitored, with action when limits are exceeded (4.20).
What's agreed, and what isn't
Special transport or storage conditions should be on the label (10.22), and carriers must know and follow them (10.23). MHRA's 2016 deficiency examples include an API shipped without temperature monitoring despite needing storage at 25 °C or below.
What does EU GMP actually say about temperature in a manufacturer's warehouse and stores?Guidance
Chapter 3, paragraph 3.19 says storage areas should be clean and dry and maintained within acceptable temperature limits, and where special storage conditions are required (for example temperature or humidity) they "should be provided, checked and monitored". Chapter 5 adds that all materials and products should be stored under the conditions established by the manufacturer (5.7), including intermediates and bulk (5.41), quarantined finished product (5.63) and released stock (5.65).
What's agreed, and what isn't
Chapter 3 never uses the words "mapping" or "alarm". MHRA inspectors have linked 3.19 to mapping in replies on their blog (a mapping study to define where probes go), and paragraph 3.3 extends the same expectation to conditions that could affect equipment. Quarantine, rejected and returned stock need their own marked, segregated areas (3.21, 3.23).
What does GMP expect for QC lab fridges and freezers holding samples, reagents and reference standards?Guidance
Chapter 6 says samples should be protected from adverse storage conditions (6.13), sampling procedures must state storage conditions (6.11), reagents and culture media should be labelled with their storage conditions (6.21) and storage instructions followed (6.22). Chapter 3 asks for adequate storage space for samples and records (3.27).
What's agreed, and what isn't
MHRA deficiency examples show where labs fall short: room temperature not recorded in sample and standard storage areas (2015), and a standards fridge checked only weekly with no max/min readout (2016). Treat a lab fridge holding reference standards like any other GMP storage unit.
What room temperature should medicines storage areas be kept at, and what can we do in hot weather without air conditioning?Guidance
SPS says that ideally all medicines storage areas would be controlled between 15 °C and 25 °C, which suits all ambient medicines. Air conditioning should be installed if possible. If it cannot be, ambient storage cabinets held at 15-25 °C can be used for small quantities. In hot weather, SPS advises keeping stock to a minimum with strict rotation, moving medicines out of direct sun, using reflective window film, and keeping windows and doors closed unless it is cooler outside. Check SmPCs, since some allow higher storage temperatures.
What's agreed, and what isn't
Manufacturers' ambient ranges can be anywhere from 8 °C to 30 °C, and the pack always takes precedence. SPS says storing a medicine outside its stated conditions takes it outside its licence and needs review under local clinical governance. The page does not set how often room temperature should be checked.
What specification should a ward medicines fridge meet?Guidance
The NHS Pharmaceutical QA Committee's model specification is: impervious, cleanable materials; a single cooler panel with no freezer box, salad drawer or door shelves; holds 2-8 °C; automatic defrost; grille shelving; an internal air-circulating fan; and a lock or child-resistant closure. Optional features are an external temperature display, an out-of-range alarm and a door-open alarm. It says cold chain medicines should always be stored in pharmacy-specification fridges.
What's agreed, and what isn't
The current SPS article makes the same broad point, adds that a laboratory fridge is unsuitable, and calls continuous monitoring and alarms good practice rather than optional extras.
What temperature and humidity does a stability chamber have to hold?Guidance
ICH Q1A(R2) sets the standard conditions. General case: long term 25 °C ± 2 °C/60% RH ± 5% RH or 30 °C ± 2 °C/65% RH ± 5% RH, intermediate 30 °C ± 2 °C/65% RH ± 5% RH, and accelerated 40 °C ± 2 °C/75% RH ± 5% RH. Refrigerated products: long term 5 °C ± 3 °C, accelerated 25 °C ± 2 °C/60% RH ± 5% RH. Frozen: long term −20 °C ± 5 °C. Products stored below −20 °C are treated case by case.
What's agreed, and what isn't
Semi-permeable containers have their own lower-humidity conditions. The tolerances are what the chamber must hold, so your monitoring limits sit inside them. A consolidated ICH Q1 revision was published as a Step 2 draft in April 2025 and was not final when this was checked.
What temperature should fresh frozen plasma be stored at, and how long is it good after thawing?Guidance
FFP should be stored at a core temperature of -25°C or below for up to 36 months; colder storage preserves coagulation factors better but makes packs more fragile. Thaw in purpose-designed equipment at 33-37°C (37°C optimal) and never refreeze. Thawed FFP should be used within 4 hours at 22 ±2°C, or up to 120 hours at 4 ±2°C, depending on indication. Pre-thawed FFP may go back into 4 ±2°C storage only once and only if it was out for under 30 minutes.
What's agreed, and what isn't
For indications other than unexpected major haemorrhage the Red Book says to use FFP within 24 hours of thawing, so the 120-hour limit does not apply to every use. The BSQR give no frozen temperature; -25°C comes from the Red Book.
What temperature should mortuary fridges and freezers run at under the HTA?Guidance
HTA post-mortem standard PFE2 guidance says bodies should be refrigerated at approximately 4°C, and the optimal operating temperature for freezer storage is around -20°C. Bodies should be moved to frozen storage after 30 days in refrigerated storage if they are not soon to be released or examined, or sooner depending on their condition. Bodies in long-term storage should be checked regularly.
What's agreed, and what isn't
These are approximate targets, not a tolerance band. Each establishment sets its own acceptable range and alarm trigger points, which must be documented and known to staff.
Can a care home use a domestic fridge, or a box in the food fridge, for residents' refrigerated medicines?Interpretation
CQC says dedicated medicines fridges should be used and domestic fridges are 'not recommended as they do not guarantee a stable temperature'. It also warns that some fridges advertised as 'medicines fridges' may hold temperatures that are too low or too high, so check the fridge can actually maintain 2-8°C. As an exception, small services that do not regularly keep refrigerated medicines could use a separate locked container in the food fridge, accessible only to trained staff, with full temperature monitoring and a full risk assessment.
What's agreed, and what isn't
This is softer than the Green Book and CQC's GP mythbuster, which say vaccines must never go in a domestic fridge. The locked-box allowance is for 'exceptional circumstances' in small services, not routine practice. Vaccines held by nursing homes should follow the stricter Green Book standard.
Can a dental practice keep its GlucaGen HypoKit in the emergency kit instead of the fridge?Interpretation
Yes. CQC dental mythbuster 4 says GlucaGen HypoKit should be stored at 2-8°C and not frozen, but it can be kept outside the fridge at no more than 25°C for 18 months, provided the manufacturer's expiry date is not exceeded, in its original package to protect it from light. The practice must be able to show either when the product came out of the fridge (for example a label with that date or a revised expiry) or that it is still safe, for example a purchase invoice showing that 18 months have not passed since delivery.
What's agreed, and what isn't
The 25°C limit means the room or kit location itself needs to stay below 25°C, and the mythbuster does not say how that should be evidenced. The 18-month figure is product-specific to GlucaGen HypoKit.
Can a GP practice keep glucagon in the emergency drugs box at room temperature?Interpretation
CQC GP mythbuster 1 says glucagon ideally requires refrigeration, but if it is stored at room temperature its expiry date is reduced and the practice should record a new expiry date. Emergency medicines should be readily accessible and not locked away, ideally in a tamper-evident box marked 'for emergency use'. Medicines with extra legal storage requirements, such as safe custody, are the exception.
What's agreed, and what isn't
The GP mythbuster does not give the shortened shelf life. CQC's dental mythbuster 4 states the GlucaGen HypoKit figure (up to 18 months at no more than 25°C, within the original expiry). Other glucagon products may differ, so check the SPC.
Can a wholesaler use a domestic fridge, or one just labelled 'medical', for fridge lines?Interpretation
The MHRA inspector's blog says a pharmaceutical refrigerator is required for refrigerated medicinal products. It describes these as fan-circulated for a uniform temperature and fast pull-down after door opening, monitored by a calibrated electronic min/max thermometer accurate to ±0.5°C that can be read without opening the door. Quoting the Green Guide, it warns that a fridge 'purported to be medical or pharmaceutical' is not automatically suitable. It should have no internal ice box and no internal dials that can be knocked.
What's agreed, and what isn't
The blog is aimed at wholesale (GDP) storage; other settings such as GP practices and pharmacies follow their own guidance (for example the Green Book and SPS), which is broadly similar. When buying, the blog suggests checking how long the unit holds temperature during a power cut and how it copes with hot spells.
Can we use a domestic freezer, or the ice box of a fridge, for frozen medicines or cold packs?Interpretation
The MHRA freezer blog says refrigerator ice boxes are 'not supported in any circumstance' for GDP use. It warns that domestic freezers may have auto-defrost cycles causing high excursions and are less able to hold a narrow range. Freezers storing medicines should be dedicated, or shown not to be affected by freezing cold packs. Most frozen medicines need -15°C to -20°C, and freezers must be qualified, monitored and mapped like refrigerators.
What's agreed, and what isn't
The blog does not ban domestic freezers outright; it lists their drawbacks and leaves the choice to qualification evidence. It also flags that combined fridge-freezers on one compressor can compromise both compartments. If you only stock a few frozen lines, it suggests not holding them or outsourcing.
Does a supported living or Shared Lives service need its own medicines fridge?Interpretation
No. CQC says medicines should be stored in people's own homes rather than centrally, including medicines that need a fridge, and that supported living services do not need a separate medicines fridge or controlled drugs cupboard. Providers should work with each person to store medicines in a way that meets their needs and the manufacturer's requirements. CQC's Shared Lives page says the same for Shared Lives carers.
What's agreed, and what isn't
CQC does not say how temperature should be assured when refrigerated medicines sit in a person's domestic fridge. Providers usually handle this through the individual risk assessment and care plan.
Does CQC require care homes to monitor room temperature where medicines are stored, and what limit applies?Interpretation
Yes. CQC says policies and procedures must set out how staff will monitor the temperature of medicines storage areas, so that medicines are kept as the manufacturer recommends. Providers also need a way for staff to escalate storage concerns or seek advice. CQC suggests a medicines storage risk assessment that, as a minimum, considers the temperature requirements of the medicines, including those kept in residents' own rooms.
What's agreed, and what isn't
CQC's page gives no numeric room-temperature limit and no recording frequency. The commonly used 'below 25°C' comes from product labels and local ICB guidance, not from CQC. Rooms where residents self-administer are within scope, which is hard to monitor in practice; a risk assessment is the expected route.
If a medicine has no storage conditions on the label, do we still need to monitor its temperature?Interpretation
Yes. EMA's GDP Q&A says it is not acceptable to leave storage unmonitored. A product without a storage statement has been justified by stability data at 25°C/60% RH or 30°C/65% RH (long term) and 40°C/75% RH (accelerated), reflecting climate zones I and II. Controls should therefore keep conditions relevant to those zones, temperature should be monitored during storage and transport, and appropriate monitoring limits should be set.
What's agreed, and what isn't
The Q&A does not give a specific numerical limit; you have to set and justify one. It applies to EU GDP, which MHRA applies in the UK through its GDP guidance, but check MHRA's own position for UK-specific nuance.
Is it a problem if our pharmacy fridge is packed full, or we chill gel packs in it?Interpretation
Quoting the Green Guide, the MHRA blog says enough space should be kept for air circulation, products should not touch the walls or floor, and if a fridge is filled to capacity, the effect on temperature distribution should be investigated. Where non-refrigerated items such as unconditioned gel packs go into the fridge, the temperature rise they cause should be assessed. Stock of different status (incoming, quarantine, returned, outgoing) should be segregated.
What's agreed, and what isn't
No fill limit is given; the expectation is evidence (for example mapping at full load) rather than a percentage rule. The 2017 freezer blog makes the same point for freezers, recommending dedicated units for medicines rather than shared use for conditioning cold packs.
What does CQC expect of the vaccine fridge itself in a GP practice?Interpretation
CQC GP mythbuster 17 restates the Green Book: use a validated fridge designed for pharmaceutical products, never a domestic fridge, and use it only for pharmaceuticals (no food or clinical specimens). Keep it locked or in a locked room, guard against accidental switch-off with a switchless socket or a 'Do not unplug/switch off' label, and make sure it is big enough for air to circulate around the packs. Keep it clean and free of ice, follow the manufacturer's servicing schedule, calibrate the temperature gauge and include it in portable appliance testing.
What's agreed, and what isn't
The mythbuster says to 'calibrate the temperature gauge' but gives no frequency or method; local ICB policy or the fridge manufacturer usually fills that gap. Inspectors assess this under the Safe key question (medicines), so a finding sits within the wider medicines-management judgement.
What does CQC say about stocking, cleaning and protecting a care home medicines fridge?Interpretation
Make sure the fridge is the right size and do not store large amounts of medicines in it, because poor airflow can lead to freezing. Check dates regularly and rotate stock according to your policy. Clean and defrost the fridge regularly and keep dated records of this. Prevent accidental power interruption with a switchless socket, a 'Do not unplug/switch off' label or a purpose-made socket cover. Keep the fridge secure, accessible only to authorised staff, and free of food and biological samples.
What temperature ranges do VMD inspectors expect for refrigerated and ambient veterinary medicines?Interpretation
VMD says cold chain products must be stored at 2-8°C and most ambient products below 25°C. It also recommends avoiding ambient storage below 12°C, because that is close to the dew point indoors and condensation can damage packaging and labels. Inspectors now expect records showing that ambient storage stays within range, not just cold chain records, in every location where medicines are kept. Medicines and vaccine fridges must not hold staff food, and inspectors can seize products whose storage may have compromised them.
What's agreed, and what isn't
The 12°C lower ambient limit is a VMD inspector recommendation, not a label requirement. RCVS supporting guidance uses an 8-25°C ambient band, so practices may see slightly different figures. The SPC always governs.
Where should the temperature probe go in a fridge, and how should we stock it?Interpretation
The MHRA blog says calibrated probes should be placed centrally, preferably between products, and not in the door. Products should be stored in an orderly way on shelves, not on the floor, so air can circulate. The fridge should be cleaned regularly and serviced at least annually, any alarm tested routinely at specified temperatures, stock rotated first expiry first out, and no food or drink kept in it.
What's agreed, and what isn't
This placement advice is a general default. EU GDP and the MHRA mapping blog expect permanent probes to be placed where mapping shows the extremes, which may not be the centre. Where these conflict, follow your mapping data and document why.
Can unused vaccines go back in the fridge after a clinic or school session?Guidance
Yes, if temperature monitoring shows the cold chain was maintained. Returned vaccines should be marked with the date and time of return, placed at the front and used at the earliest opportunity. If the cold chain cannot be confirmed, do a risk assessment as for a fridge excursion.
What's agreed, and what isn't
Without a cool box max/min record you cannot show the cold chain was kept, so the stock should be treated as an incident. Northern Ireland says vaccines should not be taken out to clinics more than once.
Can we keep food, drink or specimens in the vaccine fridge?Guidance
No. The Green Book says food, drink and clinical specimens must never be stored in the same fridge as vaccines. The 2014 protocol says the vaccine fridge should be used only for vaccines and medicines.
What's agreed, and what isn't
The protocol allows other medicines alongside vaccines. Northern Ireland is stricter and says the vaccine fridge should not store anything other than vaccines.
Can we still give temperature-excursion vaccines under a PGD?Guidance
Yes. UKHSA says current medicines law does not prevent supplying risk-assessed, temperature-excursion vaccine under a PGD, and the PGD does not need amending. Where manufacturer advice or the risk assessment supports continued use, supply or administration can continue under the PGD without a Patient Specific Direction.
What's agreed, and what isn't
UKHSA bases this on NICE MPG2 recommendation 1.1.7 (off-label use under a PGD should be supported by best clinical practice). Local PGD governance may want the risk assessment recorded. Newer legal routes (for example the 2026 Vaccine Group Direction mentioned in UKHSA COVID guidance) are outside this 2022 text.
Can we store vaccines in a domestic fridge?Guidance
No. The Green Book says vaccines and diluents must be stored in specialised pharmaceutical fridges and ordinary domestic fridges must not be used. The 2014 protocol says all practices should have a validated vaccine fridge, as domestic fridges are not suitable.
What's agreed, and what isn't
This is one of the clearest positions in UK vaccine guidance; Scotland and Northern Ireland say the same. The UKHSA incident checklist asks whether the fridge is domestic or medical, so a domestic fridge will count against you in any incident review.
Do we have to throw vaccines away after a temperature excursion?Guidance
Not automatically. UKHSA says most UK vaccines are stable and tolerate short excursions, and loss of potency is gradual. Vaccines should be quarantined at +2°C to +8°C and risk assessed using stability data, manufacturer advice and the SIT/HPT. No vaccine should be disposed of until this has been discussed and agreed with the local screening and immunisation team.
What's agreed, and what isn't
Vaccines assessed as usable become 'off-label' unless the SPC covers the excursion. Vaccines that have been frozen (below 0°C) should be disposed of. UKHSA says its disposal thresholds are deliberately conservative, so advice to discard does not mean the vaccine was definitely ineffective.
Do we need a back-up plan for vaccine storage if the power fails?Guidance
Yes. The Green Book says back-up facilities should be available if the fridge fails, and UKHSA's incident guidance expects every provider to have a written emergency storage plan for excursions and breakdowns. The 2026 UKHSA poster says to have back-up storage in case of power failure.
What's agreed, and what isn't
UKHSA does not say what the back-up must be; options include another pharmaceutical fridge or validated medical cool boxes. Vaccine Update 338 reported that in 2022 power cuts accounted for half of the value of vaccine wasted, which is why UKHSA urges low stock holdings.
Do we need a data logger, or is a max/min thermometer enough?Guidance
In England, the Green Book minimum is a max/min thermometer that monitors continuously, with digital thermometers called the most reliable. It notes that alarmed digital thermometers and data loggers are available but does not require them. The UKHSA incident guidance relies heavily on logger data to work out how long a breach lasted.
What's agreed, and what isn't
This is a gap: a max/min thermometer shows how high or low the temperature went but not for how long, yet UKHSA's 20-minute allowance depends on duration. Northern Ireland says data loggers should be used, set at 5-minute intervals and reviewed weekly, alongside paper records. Scotland recommends considering continuous wireless monitoring.
Do we need a switchless socket or plug guard on the vaccine fridge?Guidance
The Green Book says steps should be taken to reduce the chance of the power being cut off by accident, such as installing a switchless socket or clearly labelling the fridge plug. The 2014 protocol says fridges must be wired into switchless sockets, and the 2026 poster says to mark or tape the plug.
What's agreed, and what isn't
The sources differ on strength: the Green Book accepts labelling as an alternative, while the protocol lists switchless wiring as a 'must'. Public Health Scotland prefers wiring the fridge directly into the supply (a 'spur'), with physical protection of the plug as a fallback. The UKHSA incident checklist asks whether the power supply is protected from disconnection.
Does a vaccine fridge need a second thermometer as well as the built-in display?Guidance
The Green Book says to use at least one max/min thermometer that runs independently of mains power, in addition to any built-in thermometer, so temperatures can still be measured if the power fails. The 2014 protocol says all fridges should ideally have two thermometers, one of them a max/min thermometer independent of mains power.
What's agreed, and what isn't
The protocol says that if only one thermometer is used, a monthly check of its calibration 'should be considered'. That is softer than the Green Book's 'at least one ... independent of mains power should be used'. Northern Ireland asks for a data logger as a back-up to the built-in thermometer.
How full can I stock the vaccine fridge, and where should vaccines go?Guidance
The Green Book says to leave enough space around vaccine packages for air to circulate and to keep vaccines away from the side and back walls, where they may freeze. The 2026 poster says not to overfill, to keep vaccines in their original packaging in the main part of the fridge rather than in drawers, and to put the shortest-dated stock at the front.
What's agreed, and what isn't
The Green Book and UKHSA do not give a percentage. Public Health Scotland says no more than two-thirds of the internal volume, with about a 4 cm gap from the walls. Northern Ireland says no more than 50% full and never in the door. Follow the fridge manufacturer's loading guidance where it exists.
How long must vaccine fridge temperature records be kept?Guidance
The Green Book says records should be readily accessible, kept for at least one year, and cover the full storage history of anything in the fridge. Because vaccine shelf lives can be four years or more, it says keeping records for five years will generally cover the full storage history.
What's agreed, and what isn't
Strictly, the minimum is one year plus whatever covers the stock's storage history. Five years is a practical rule of thumb, not a fixed requirement. Northern Ireland simply says five years for daily records and cool box records. Scotland mirrors the Green Book wording (life of the stock, at least one year, five years advised).
How often do I need to read and record the vaccine fridge min/max temperature in England?Guidance
Green Book chapter 3 says fridge temperatures must be monitored and recorded at least once each working day on a temperature chart. The reading (current, maximum and minimum) should be taken at the same time every day of the working week and each entry signed. The 2014 PHE protocol repeats this.
What's agreed, and what isn't
Once a day is the minimum in England. Public Health Scotland recommends twice daily (start and end of the session) and the Northern Ireland PHA says at least daily, preferably twice. The Green Book says nothing about weekends or non-working days, so a reading on Monday morning has to cover the whole weekend through the max/min memory. Local commissioners and NHS trust policies often ask for twice daily.
How often do vaccine fridge thermometers need calibrating?Guidance
The Green Book says the independent max/min thermometer should be calibrated every year, and the fridge should have a maintenance contract covering at least yearly servicing and calibration of the temperature gauge. The 2014 protocol also says to check the temperature at least monthly against an independently powered external thermometer.
What's agreed, and what isn't
Annual calibration is the consistent minimum. The monthly cross-check comes only from the 2014 protocol. Public Health Scotland adds that calibration should be traceable to national standards (for example UKAS). The Green Book does not define what 'calibrated' means for a cheap digital thermometer.
How often should cool box temperatures be recorded during a vaccination session?Guidance
The Green Book says cool box temperatures should be monitored while in use with max/min thermometers, and recorded at the start and end of each session. The 2014 protocol says to monitor max/min temperature while the box is in use.
What's agreed, and what isn't
The Green Book adds that cool boxes lose performance with age and use, so monitoring is always needed. Public Health Scotland suggests in-house checks of cool boxes twice a year (winter and summer) over the longest routes. Northern Ireland asks for cool box records to be kept for five years with the related fridge records.
If vaccines are cleared for use after an excursion, are they still licensed?Guidance
Generally not. Unless the SPC covers the excursion, extra stability data from the manufacturer has not been assessed by the MHRA/EMA, so using the vaccine is off-label. Off-label use of a risk-assessed vaccine may still be appropriate clinical practice, and those advising should tell vaccinators it is off-label. Cleared stock should be labelled as involved in an incident and used first.
What's agreed, and what isn't
The Green Book and the 2014 protocol say that vaccine not stored at +2°C to +8°C 'is no longer a licensed product'. The 2022 incident guidance does not contradict this but makes the practical route explicit (off-label use after a risk assessment). UKHSA's public leaflet explains this to patients.
Is 8.3°C or 1.6°C a cold chain breach?Guidance
UKHSA's 2022 incident guidance says some manufacturers allow readings to be rounded to the nearest whole number, so readings between +1.5°C and +8.4°C may count as within +2°C to +8°C. Always check with the vaccine manufacturer that this applies to their product.
What's agreed, and what isn't
This rounding was added in the July 2022 revision. Not every manufacturer accepts it, so it is product-specific, not a blanket UKHSA allowance. Readings should still be recorded and acted on.
Is the vaccine fridge recording requirement different in Scotland?Guidance
Public Health Scotland (2023) recommends recording current, max and min temperatures twice daily, at the start and end of the working session, on all working days. It acknowledges the Green Book accepts once daily as a minimum. Analogue thermometers are not acceptable; devices should read to one decimal place with ±1°C accuracy.
What's agreed, and what isn't
This is stricter than the Green Book. PHS also asks that a new or moved fridge be run for 48 hours with twice-daily checks before use, that fridges be filled to no more than two-thirds, and that SOPs be reviewed every two years.
Is there any allowance for nasal flu vaccine (LAIV) being out of the fridge?Guidance
UKHSA's flu guidance quotes the Fluenz SmPC: the vaccine is stable for 12 hours at 8°C to 25°C, and after that should be used immediately or discarded. If LAIV is involved in a cold chain incident, do not dispose of it straight away: label and isolate it at +2°C to +8°C and seek advice from the SIT and the manufacturer.
What's agreed, and what isn't
This is a product-specific SmPC allowance and cannot be applied to other vaccines. UKHSA also says not to hold more than 2 weeks of LAIV because of its short shelf life (15 weeks from production) and the risk of large losses if a fridge fails.
Our vaccine fridge has broken down. What are the first steps?Guidance
The Green Book says to keep the fridge door closed until you have assessed the situation and made a plan, and to inform the provider or commissioner and immunisation lead. Then establish the last reliable reading and the timing and cause, quarantine affected vaccines in the cold chain with clear labels, and record everything. Follow-up may include revaccinating patients; unusable vaccines are disposed of under local protocols.
What's agreed, and what isn't
The UKHSA incident guidance adds: leave the fridge switched on at the mains with probes undisturbed, and do not discard vaccines or equipment until the SIT/HPT has been consulted. Back-up storage should already be arranged before any failure.
The fridge went to 10°C briefly while we restocked it. Do we need to do anything?Guidance
The UKHSA incident guidance says one-off rises above +8°C lasting less than 20 minutes, such as during stock-taking or restocking, are unlikely to have breached the cold chain and need no further action. Write the cause on the temperature chart, reset the max/min thermometer, and keep using the vaccines to their expiry date.
What's agreed, and what isn't
This only applies if you know the excursion was a one-off and lasted under 20 minutes, the vaccines were in their original packaging, and storage before it was good. It is NHS clinical guidance and does not apply to WDA or MIA holders, for whom every excursion is a deviation under GDP and GMP. A max/min thermometer alone cannot tell you the duration, so you need a data logger or a witnessed event. Repeated or unexplained excursions are not covered.
The minimum reading dropped to 1°C. Are the vaccines still usable?Guidance
UKHSA says vaccines whose recorded minimum was between 0°C and +2°C are unlikely to have been affected. Where the fridge temperature has been verified, they can usually be used up to their expiry date, and doses already given usually do not need repeating.
What's agreed, and what isn't
This assumes the thermometer is accurate and the vaccines did not actually freeze, for example vaccines touching the back wall can be colder than the probe. Below 0°C the advice changes to dispose. Investigate why the fridge is running cold.
We arrived this morning and the max reading was 9°C overnight. What do we do?Guidance
Treat it as a possible cold chain breach. Find and fix the cause if you can, then label the affected vaccines 'not for use' and keep them at +2°C to +8°C, moving them to another monitored fridge if needed. Leave the fridge switched on with probes undisturbed, complete the incident checklist, take an inventory, and report to the local screening and immunisation team. Do not discard anything until that discussion.
What's agreed, and what isn't
UKHSA says some manufacturers allow rounding, so a reading up to +8.4°C may count as +8°C, but 9°C is outside that. For a single moderate overnight excursion, UKHSA expects most risk assessments to find vaccines still usable, but this needs manufacturer and SIT advice. Without logger data you will not know how long the fridge was above 8°C.
We have already given vaccines from a fridge that turned out to have failed. What now?Guidance
UKHSA says that if compromised vaccines have been given, the provider should consider forming an Incident Control Team (provider lead, SIT, HPT, communications and others). The team decides whether duty of candour requires telling patients and whether revaccination is needed, using UKHSA's revaccination tables.
What's agreed, and what isn't
The threshold for revaccination is different from the threshold for discarding stock: an incident that leads to disposal does not necessarily mean everyone needs revaccinating. For COVID-19 vaccines, UKHSA asks for incident-specific advice because its general guidance may not apply.
What are the 'four Rs' of vaccine fridge monitoring?Guidance
Read the thermometer's current, maximum and minimum temperatures every working day at the same time; Record them on a standard form and sign each entry; Reset the thermometer after each reading, and again once temperatures settle after busy periods; React if the temperature is outside +2°C to +8°C, and write down what you did.
What's agreed, and what isn't
The Green Book lets named staff delegate monitoring to others, but only if those staff understand the whole process. If nobody resets the thermometer, every later reading shows the old maximum, which makes an incident hard to investigate.
What counts as a vaccine cold chain breach that has to be reported?Guidance
The SW ICARS toolkit treats any excursion above +8 °C for more than 20 minutes, or below +2 °C for any length of time, as a breach to report so that stability can be assessed. One-off rises above 8 °C lasting under 20 minutes, for example during restocking, need no further action beyond documenting the cause, resetting the thermometer and continuing to use the vaccines. Breached vaccines are quarantined in a working fridge, labelled "Not for Use", and must not be discarded until advice is received.
What's agreed, and what isn't
ICARS can only advise on vaccines in routine programmes. For travel vaccines, contact the manufacturer. If stability is confirmed only from the manufacturer's in-house data, the toolkit says using the vaccine is off-label. NHS England supports this where a sound risk assessment has been done, but the decision rests with the practice.
What do we need to take vaccines to an off-site clinic or home visit?Guidance
Use a validated medical-grade cool box and cool packs from a recognised medical supplier, never a domestic cool box, with a validated max/min thermometer. Keep vaccines in their original packaging, wrapped in bubble wrap or similar so they do not touch the cool packs. Take only what the session needs and keep opening to a minimum.
What's agreed, and what isn't
Cool packs are normally stored at +2°C to +8°C, not frozen, unless the cool box manufacturer says otherwise. The Green Book does not set a maximum transit time. Northern Ireland's guidance covers short transits of under two hours and says vaccines should not go out and back to clinics more than once.
What does UKHSA expect us to investigate after a fridge temperature breach?Guidance
Get a fridge engineer to inspect the fridge and check thermometers and data loggers, unless the cause was clearly unrelated, such as a power cut. Record the fridge's condition, alarm settings, power protection and age; check the service history and temperature records; and collect stock evidence. Where possible, run a data logger for 48 hours to see the fridge's temperature pattern.
What's agreed, and what isn't
The algorithm in the same document says 48 to 72 hours of data logging. The checklist also asks how long the fridge is out of range before the alarm sounds, so set alarm parameters deliberately and know what they are.
What extra requirements apply to GP vaccine fridges in Northern Ireland?Guidance
The PHA (2024) says temperatures should be checked at least daily, preferably twice daily, and a data logger should be used as a back-up, set to record at 5-minute intervals and reviewed weekly. Excursions outside 2 to 8°C lasting over 20 minutes are significant breaches. Report them the same day to HSC Trust Medicines Information and the PHA Health Protection Duty Room.
What's agreed, and what isn't
NI also sets five-year retention for daily records, fridges no more than 50% full, and paper records kept even when a logger is used. Reporting goes through Medicines Information and the PHA rather than an NHS England SIT. Responsibility for the use decision stays with the GP practice.
What happens if vaccines were exposed to temperatures below 0°C?Guidance
UKHSA says any vaccine that has been frozen or is known to have been below 0°C should be disposed of. Freezing can denature proteins, break the bond between aluminium adjuvant and antigen, and crack vials, risking contamination. If affected vaccine has already been given, a risk assessment decides whether to revaccinate.
What's agreed, and what isn't
Freeze-dried vaccines (for example MMR) are mostly unaffected by freezing in powder form, but diluents must not be frozen. Frozen vaccine may look normal, though damp or 'waxy' boxes can be a clue. The 'shake test' needs experienced staff to be reliable.
What maintenance records should we keep for a vaccine fridge?Guidance
The Green Book says to keep records of regular servicing, defrosting and cleaning, calibration and electrical (PAT) testing, on a log sheet kept with the fridge. Each fridge should have a unique identifier such as a serial number. It should be serviced at least yearly, sited in a ventilated place away from heat, and kept free of ice build-up.
What's agreed, and what isn't
If the fridge must be defrosted, the Green Book says to move vaccines to another fridge or a validated cool box for as short a time as possible. Scotland notes most incidents involve fridges over five years old and suggests planned replacement.
What routine checks of vaccine stock and fridge records does guidance expect?Guidance
The 2014 protocol asks for weekly checks of fridge contents (rotation and expiry), monthly stock audits, and three-monthly audit records that can be shared with the local screening and immunisation team, plus a quarterly vaccine management review. The Green Book asks for stock records to be checked and updated at least monthly and includes a monthly review line on its sample temperature chart.
What's agreed, and what isn't
The 2014 PHE protocol has not been revised since; UKHSA still hosts it but it refers to NHS England screening and immunisation teams and older NPSA/HPA links. Scotland asks for an annual site audit; Northern Ireland asks for weekly data logger reviews and an annual audit.
What should I do if I think our fridge thermometer is faulty?Guidance
The Green Book says to consider whether this affects the cold chain storage of current stock and of vaccines given recently, to inform the provider or commissioning organisation, and to make servicing the fridge a priority.
What's agreed, and what isn't
The PHE CQC Q&A (2014) says not to throw away vaccines just because a thermometer was not calibrated. If readings look plausible, keep using the vaccines, get the thermometer calibrated, and consider placing a data logger in the fridge for about 48 hours as an independent check.
What should we check when a vaccine delivery arrives?Guidance
Check the delivery against the order for discrepancies, leaks or damage before signing for it, then refrigerate immediately; vaccines must not be left at room temperature. Record the receipt on a stock inventory. The Green Book notes that distributors and manufacturers will not take vaccines back once they have left their control.
What's agreed, and what isn't
Because returns are not accepted, a delivery left unrefrigerated at reception becomes the practice's own excursion to manage. The 2026 Vaccine Update repeats that returns cannot be accepted, so check you have fridge capacity before ordering.
What temperature should my vaccine fridge be at?Guidance
Vaccines should be stored as their SPC says, which for almost all vaccines is +2°C to +8°C, protected from light and in their original packaging. The Green Book says good practice is to aim for +5°C, the middle of the range, and the 2026 UKHSA poster says 'Strive for 5°C'.
What's agreed, and what isn't
Some products differ: for example, Imvanex is delivered at -20°C and can be kept frozen or moved to +2°C to +8°C with a shorter expiry. Always check the SPC. Green Book chapter 3 is dated June 2013 inside the PDF (GOV.UK page shows first published 19 March 2013, never updated); some links and organisation names (HPA, DH protocol URL) are out of date.
Where do I find storage and thawed shelf-life rules for COVID-19 vaccines?Guidance
UKHSA's COVID-19 guidance for healthcare practitioners no longer has its own storage appendices. It points to the product SPCs and to the NHS Specialist Pharmacy Service for storage, transport and handling. Storage or preparation errors should be reported under local policy, and expert advice sought where a dose may have lost potency.
What's agreed, and what isn't
The UKHSA incident guidance (2022) also says not all of its advice may apply to COVID-19 vaccines and asks for vaccine-specific advice. Thawed shelf lives are product-specific SPC limits and should not be generalised to other vaccines.
Who decides whether we can still use vaccines after a cold chain breach?Guidance
The provider where the breach happened makes the decision, case by case, after a full risk assessment that includes specialist advice from the local HPT, the SIT and the vaccine manufacturer. If the vaccines are used, the prescriber or provider takes responsibility, so the advice and reasoning must be well documented.
What's agreed, and what isn't
Manufacturers can share in-house stability data but are not obliged to accept liability for use outside the licence. The Green Book (2013) also says using such vaccines is the user's responsibility. In Northern Ireland, HSC Trust Medicines Information supports the risk assessment, but responsibility stays with the GP practice.
Who do we report a vaccine fridge failure to in England?Guidance
Report all vaccine storage incidents to the local NHS England screening and immunisation team (SIT) first, and record them through local governance. If vaccines are wasted, complete an ImmForm stock incident record. Serious incidents follow the NHS England serious incident framework.
What's agreed, and what isn't
The 2022 guidance names 'NHSEI' and the Serious Incidents Framework; both have since changed names or been replaced (for example by PSIRF), so follow current local arrangements. Some regions now route advice through other services, such as South West ICARS. The 2014 protocol also says to report on ImmForm.
Who should be responsible for vaccine storage in a GP practice?Guidance
The Green Book says at least two named people should be nominated, one from the nursing team and one from administration or management, to be responsible for ordering, receipt and care of vaccines. They are responsible for cold chain recording, stock rotation and correct disposal, and can delegate temperature monitoring to trained staff.
What's agreed, and what isn't
UKHSA's incident guidance and Vaccine Update also expect everyone who orders, stores or handles vaccines to be trained and assessed as competent. Scotland uses a 'vaccine responsible person' plus a deputy and SOPs reviewed every two years; Northern Ireland uses a named 'Vaccine Controller'.
CQC found gaps in our vaccine fridge temperature records. Do we have to destroy the vaccines?Interpretation
No. PHE's Q&A says gaps or missing records do not on their own mean vaccines were stored badly. Do not dispose of vaccines or equipment; contact the local screening and immunisation team. Evidence such as stock inventories, delivery dates, stock turnover and the fridge's age, condition and service history can give reassurance.
What's agreed, and what isn't
This is a 2014 Q&A that refers to the withdrawn ImmForm helpsheet 18, but it matches the current 2022 UKHSA incident guidance (section 7.2: do not discard anything until discussed with the SIT/HPT). If there is real doubt, label the vaccines 'do not use' and quarantine the fridge while a risk assessment is done.
Do we have to record wasted vaccines on ImmForm?Interpretation
Yes for centrally supplied stock. UKHSA asks that vaccines judged compromised are destroyed under local waste policy and recorded through the ImmForm Stock Incident page; expired stock should also be recorded there. UKHSA uses these reports to track wastage: £6.4 million reported in 2025, of which 84% was avoidable.
What's agreed, and what isn't
UKHSA describes ImmForm reporting as voluntary in its 2026 wastage article, and suspects under-reporting. This is separate from local incident reporting and from reporting to the SIT. The old ImmForm helpsheet 18 on fridge failures has been withdrawn.
How much vaccine stock should we hold?Interpretation
The Green Book says providers should hold no more than two to four weeks' supply and should order small quantities regularly. Vaccine Update issues from 2022 to 2025 told ImmForm customers to order no more than 2 weeks' stock of many products to limit losses from fridge failures. From 2026 the wording returned to 2 to 4 weeks of booked appointments.
What's agreed, and what isn't
UKHSA's own wording has moved between 2 weeks and 2 to 4 weeks depending on the product and the year. For seasonal flu vaccines and LAIV, UKHSA recommends no more than 2 weeks. Public Health Scotland says no more than two weeks in frontline clinical settings.
After a fridge excursion, do medicines stay out of the fridge until someone decides what to do with them?Guidance
No. SPS says that unless you have specific information to the contrary, most medicines should go back into a fridge after exposure outside 2-8 °C. They stay quarantined and labelled "DO NOT USE" while the assessment is done. If the original fridge has not come back into range, move the stock to another fridge if one is available. Frozen stock stays in a freezer. If the only freezer has failed, leave the stock inside with the door shut.
What's agreed, and what isn't
Returning stock to the fridge means storing it while it is assessed, not releasing it for use. The SW ICARS toolkit gives the same instruction for vaccines: quarantine them in a working fridge, or keep the failed fridge closed and undisturbed.
After a heatwave, how much should we shorten the expiry of 'store below 25 °C' medicines kept on the ward?Guidance
The NHS Pharmaceutical QA Committee gives a worst-case Q10 = 4 rule of thumb for products labelled 25 °C or below. At 25-30 °C, reduce the expiry by 2 days for 24 hours of exposure, or by 2 weeks for a week. At 30-35 °C, reduce it by 4 days for 24 hours, or 4 weeks for a week. At 35-40 °C, reduce it by 8 days for 24 hours, or 8 weeks for a week. A worked example treats 2 weeks at 35 °C as equal to 8 weeks at 25 °C.
What's agreed, and what isn't
The document says the MHRA will not accept this method under GDP. It is for risk-managed clinical areas only, not the pharmacy-controlled supply chain. It ignores humidity, should not be relied on above 40 °C, and does not apply to cold excursions. The Newcastle case study adds that medicines outside their original primary packaging, exposed above their SmPC limit, should be disposed of.
At what point should ward staff quarantine medicines after an out-of-range reading?Guidance
The 2015 NHS Pharmaceutical QA Committee document gives example triggers. For fridges: quarantine if vaccines may have been frozen, or if contents may have been above 8 °C for more than half an hour where highly temperature-sensitive medicines are stored. For ambient areas: quarantine if the temperature exceeded the upper limit by more than 5 °C, or for more than a day. Out-of-limit results should always be reported to the appropriate person in the clinical area.
What's agreed, and what isn't
These are examples and differ from the current SPS position. SPS now says to quarantine with a "DO NOT USE" label at the start of every excursion assessment, and treats a single ambient excursion of less than 5 °C for under 7 days as unlikely to matter. Prefer the current SPS process where they differ.
Can a customer return a fridge item to us so we can resell it?Guidance
Only with documented evidence that the product was kept under its authorised storage conditions the whole time. EU GDP 6.3 says that if any deviation has occurred, a risk assessment must show the product's integrity, and the evidence should cover delivery to the customer, examination, opening of transport packaging, return to packaging, collection and return, and return to the distributor's fridge. The general return conditions also apply: unopened, undamaged, in date, not recalled, and assessed by a trained, authorised person.
What's agreed, and what isn't
For returns from customers without a wholesale authorisation, EU GDP gives 'for example 10 days' as an acceptable time limit. That is not the UK expectation: in GB the MHRA position (Inspectorate blog, 5 May 2016) is that refrigerated returns from unlicensed sites are completed within 24 hours including transport, and ambient returns within five days. Go beyond that only if agreed with the GDP Inspectorate in writing. In practice, many wholesalers refuse refrigerated returns altogether.
Can a returned fridge line go back into saleable stock in Ireland?Guidance
HPRA policy is that cold-chain products may only be returned to saleable stock where there is no reasonable possibility the cold chain was compromised. Examples given are where the batch was recorded on distribution and the whole delivery-and-return process is validated, or where a unique monitoring device attached to the product shows whether it left refrigerated conditions.
What's agreed, and what isn't
This closely mirrors EU GDP section 6.3, which already requires documented evidence of authorised storage throughout and lists the same chain of steps (delivery, examination, re-packing, collection, return to the fridge); the HPRA adds the attached-monitor option. If any deviation occurred, EU GDP requires a risk assessment demonstrating product integrity. Returns criteria should be established in procedures.
Can we use mean kinetic temperature (MKT) to justify an ambient excursion in Ireland?Guidance
Only under strict conditions. IA-G0011 says MKT applies only to controlled room temperature products (e.g. 'Do not store above 25°C'), never to refrigerated products, cannot compensate for poor premises control, and storage temperatures should not exceed 30°C at any point if MKT is used. The MA holder should be consulted on whether MKT is applicable, and excursions outside labelled conditions should still be documented, investigated and reported to the MA holder.
What's agreed, and what isn't
Use of MKT should be described in a written procedure and the number of excursions above label limits kept limited. Whether MKT is acceptable for a given product depends on the product's stability data, so the MAH's view is decisive.
Does the QP have to consider storage and transport temperatures before certifying a batch?Guidance
Yes. Annex 16, 1.5.3 says conditions of storage and transport for the batch, and for the sample if sent separately, should be taken into account by the QP before certification. For imported batches the QP should be satisfied that the finished product has been stored and transported under the required conditions (1.5.7). Section 3 allows certification after an unexpected deviation only where its impact is evaluated and shown to be negligible.
What's agreed, and what isn't
Section 3 does not mention temperature by name; MHRA's 2016 blog on unexpected deviations applies it to a transit excursion and warns that routinely using stability data to justify excursions would not be acceptable.
For a general sale (GSL) wholesaler in Ireland, how should a temperature deviation be classified in our own deviation system?Guidance
The HPRA's model quality system for general sale wholesalers gives 'temperature deviations' as an example of a Major deviation (potential to compromise product quality) in the company's own classification scheme, alongside a Critical tier (e.g. failure to quarantine unsuitable product) and a Minor tier. Its temperature SOP template requires initial mapping or a documented RP-approved risk assessment, worst-case probe placement and daily max/min recording.
What's agreed, and what isn't
This is a company-level deviation classification example, not the HPRA's inspection grading. The guide says inspection frequency for these distributors is risk-based, between six months and five years.
How long can a unit of red cells be out of the blood fridge and still go back into stock?Guidance
Where possible, keep red cells out of 2-6°C controlled storage for under 30 minutes. If 30 minutes is exceeded, the unit should not go back into the issue fridge but should be returned to the transfusion laboratory or quarantined remotely with electronic tracking. Up to 60 minutes is acceptable if the unit is then quarantined in a secure fridge for at least 6 hours before reissue, and a unit should not have more than three 30-60 minute episodes. Transfusion should be completed within 4 hours of leaving controlled temperature.
What's agreed, and what isn't
Hospitals need tracking (often electronic blood-tracking systems) to count episodes per unit; without it the three-occasion limit cannot be shown.
If medicines are judged usable after an excursion but with a shorter shelf life, how should we label them?Guidance
SPS lists three possible outcomes: usable with a shortened shelf life, usable with extra patient monitoring, or not usable and discarded. If the medicine is usable, return it to correct storage, consider a sticker recording the excursion, and shorten the expiry date in line with local policy. Obscure the original expiry date but keep the batch number visible. Destroyed stock should be recorded in the stock control system, disposed of appropriately and reordered if needed.
What's agreed, and what isn't
Who can authorise a shortened expiry date is a matter for local policy. SPS suggests involving a stability expert, a clinician or a manager.
Our blood fridge failed overnight. Can the red cells still be used?Guidance
The Red Book allows red cells to be released for transfusion after an exceptional excursion caused by equipment failure, provided the core temperature stayed between 1°C and 10°C. The unit must have had only one such excursion, lasting no more than 5 hours, there must be a documented system for such events, and adequate records of the incident must be kept. Otherwise, variation from 4 ±2°C must be kept to the short periods needed for examining, labelling or issuing.
What's agreed, and what isn't
The criteria refer to core temperature, but most fridge monitoring measures air or simulated product temperature, so you need to justify how core temperature was inferred, for example from a load probe. Anything outside these limits needs a quality decision, usually discard.
Our data logger shows the dispensary hits 27 °C every afternoon but cools overnight. Can we use mean kinetic temperature instead of treating each spike as an excursion?Guidance
SPS says MKT can be used to average out temperature peaks. Its example is a short afternoon spike that may be disregarded if the daily MKT stays within the labelled range. The 2015 NHS Pharmaceutical QA Committee document adds that MKT needs continuous logger data, because it cannot be calculated from min/max readings. It applies only to high temperatures, and it should not be used routinely to compensate for poor storage conditions.
What's agreed, and what isn't
MKT is not the same as the average temperature. The 2015 document also says there is no risk only if the maximum stays below 40 °C and the MKT stays below the product's upper limit. Regular spikes still point to a storage problem that should be fixed.
Our fridge minimum reading was 0.5 °C. Is a low reading less serious than a high one?Guidance
No. SPS says excursions below 2 °C are "always potentially significant and should be fully explored". Freezing can irreversibly damage biologicals, vaccines and some containers, such as syringes. SPS also treats every freezer excursion as potentially significant.
What's agreed, and what isn't
Low readings are often caused by a fridge thermostat fault, stock touching the cooling plate, or a probe placed against the back wall. Investigate the cause as well as the stock. Unlike high-temperature excursions, low ones cannot be offset with MKT or Q10 estimates.
Our stability chamber went out of tolerance overnight. Does every excursion have to be reported?Guidance
Not every one. ICH Q1A(R2) says the chamber should be capable of controlling the condition within the defined ranges and the actual temperature and humidity should be monitored. Short spikes from opening doors are "accepted as unavoidable". The effect of excursions due to equipment failure should be addressed, and reported if judged to affect stability results. Excursions beyond the tolerances for more than 24 hours should be described in the study report and their effect assessed.
What's agreed, and what isn't
The 24-hour figure is a reporting threshold for the study, not a delay before you act. Under GMP the excursion is still a deviation in your quality system (Chapter 6, 6.35 for atypical trends). The 2025 draft ICH Q1 carries the same wording into its section 7.1.
Our treatment room reached 28 °C for three days during hot weather. Are the 'store below 25 °C' medicines still usable?Guidance
SPS says a single, isolated excursion of less than 5 °C above the labelled maximum storage temperature, lasting less than 7 days, is unlikely to have an adverse effect on medicines. A 28 °C peak over three days for products labelled 25 °C falls inside that. Some products allow up to 30 °C, and some have no stated storage conditions.
What's agreed, and what isn't
The rule covers a single, isolated event. It does not cover rooms that run hot every summer, which call for a documented risk assessment and possibly shortened expiry dates or cooling. SPS notes that Wholesale Dealer's Licence holders and others with regulatory requirements must still meet those requirements in full. The 2015 NHS Pharmaceutical QA Committee document quarantines ambient stock at a stricter point: more than 5 °C over the limit, or for more than a day.
Our ward fridge is reading 10 °C. What should we do first?Guidance
SPS sets out a stepwise process. First fix any obvious cause (door left open, power switched off), keep the door shut and check the sensors are placed correctly and working. Then quarantine the stock with a "DO NOT USE" label, record the maximum and minimum temperatures and total time out of range, and assess each product against its SmPC, the SPS refrigerated medicines stability tool or the manufacturer's medical information before anyone uses it. If no cause can be found, take the fridge out of use and label it until the investigation is complete.
What's agreed, and what isn't
SPS does not set a single temperature at which stock must be thrown away. The decision is made product by product and depends on how long the fridge was out of range and on each product's stability data. Vaccines follow UKHSA vaccine incident guidance and reporting routes, not just this generic process.
The fridge went above 8 °C for about 15 minutes while we restocked it. Is that a problem?Guidance
SPS cites US NIST studies showing that vaccine vials stay below +8 °C for at least 20 minutes during a power loss or a continuous inflow of ambient air. SPS says it is reasonable to extend this to other refrigerated medicines. So an excursion above 8 °C lasting under 20 minutes, with medicines in their original packaging, is unlikely to have warmed the medicines above 8 °C. SPS still says to record every excursion locally, however minor.
What's agreed, and what isn't
The 20-minute figure is NHS clinical guidance and does not apply to WDA or MIA holders: under GDP and GMP every excursion is a deviation. It is an extrapolation from vaccine-vial studies. It assumes original outer packaging and a reasonably full fridge, so loose syringes or small volumes may warm faster. The NHS England SW ICARS toolkit uses the same threshold for vaccines: over 8 °C for more than 20 minutes is treated as a reportable breach.
We only have a min/max thermometer. How do we work out how long the fridge was out of range?Guidance
SPS says to assume the excursion started just after the min/max recorder was last reset, unless you have information showing otherwise. Where a continuous data logger is fitted, download it, because it shows the actual profile and length of the excursion. SPS says min/max recorders are of limited value for excursion assessment because they cannot show timing or duration.
What's agreed, and what isn't
With a min/max thermometer that is reset once a day, the worst-case assumption can mean stock is treated as out of range for up to 24 hours, or about 72 hours over a weekend. That can lead to discarding stock that a logger would have shown was fine.
We sometimes cannot keep medicines within the labelled temperature, for example in an ambulance. What does RPS expect?Guidance
RPS says storage arrangements and monitoring should be based on risk, taking account of the medicines, how long they are stored and the room temperature. Storing or using a medicine outside the manufacturer's range requires a full risk assessment. There must be a policy and procedure for temperature excursions, with assurance that it is followed. If product integrity cannot be guaranteed, any decision to use the medicine must be fully risk assessed, and vaccines have their own guidance.
What's agreed, and what isn't
RPS sets the principle but not the method. The SPS excursion process and the NHS Pharmaceutical QA Committee clinical-area risk tools (Q10, MKT) are the usual way to carry it out.
What do we need to write down after a temperature excursion?Guidance
SPS says to document every excursion locally, however minor, so patterns can be spotted. The minimum record is: who you are, when the excursion happened and how far out of range it went, the medicines and batch numbers affected, what advice was sought and from whom, and the actions taken to stop it happening again. The event should also go through your adverse incident procedure.
What's agreed, and what isn't
SPS also asks you to note whether a product has had a previous excursion. This matters because stability allowances are not unlimited and multiple excursions add up. SW ICARS makes the same point for vaccines.
What does GDP say we must do when a temperature excursion happens in transit?Guidance
EU GDP 9.2 says a deviation such as a temperature excursion during transport should be reported to the distributor and to the recipient of the affected products, and a procedure should be in place for investigating and handling excursions. Risk assessment of delivery routes should decide where temperature controls are needed.
What's agreed, and what isn't
The guideline does not define how long an excursion has to last before it counts, or who decides whether the product can be used. In practice the RP decides disposition, using stability information from the manufacturer or marketing authorisation holder. MHRA inspectors have warned that such data is often not directly comparable to the excursion.
What does the HPRA say we must do after a temperature excursion?Guidance
The HPRA defines an excursion as a deviation from labelled storage conditions 'for any duration of time' in storage or transport. Excursions should be notified immediately to the RP, affected product quarantined until the investigation outcome is known, the manufacturer/MAH consulted on quality impact, the investigation and outcome documented, and corrective actions implemented. If a recall may be required, the HPRA should be notified immediately.
What's agreed, and what isn't
Excursions in fridges or freezers used only to condition ice packs should be investigated with equal thoroughness. The guide does not set a minimum duration below which an excursion can be ignored, which differs from informal commentary elsewhere about very short excursions.
Where can I check whether a fridge medicine is still usable after being out of the fridge?Guidance
SPS runs a refrigerated medicines stability tool, currently a pilot, giving advice on whether refrigerated medicines can or cannot be used after exposure to out-of-range temperatures. The SPS excursion guidance says to use it alongside the brand-specific SmPC and the manufacturer's medical information department. If a product is not in the tool, contact the manufacturer directly.
What's agreed, and what isn't
Stability data is brand-specific, and SPS asks you to confirm the marketing authorisation number. Previous excursions count against the allowance. For vaccines, follow UKHSA vaccine incident guidance and the local screening and immunisation or ICARS team instead.
A cold chain delivery arrived warm or with ice packs touching the product - what should we do?Interpretation
The MHRA blog says the person receiving the delivery must check it was transported properly, for example no direct contact with gel or ice blocks and not warm to the touch. If that cannot be confirmed, the delivery should be quarantined in a suitable fridge while the supplier is asked, and treated as unsuitable for supply until resolved. If doubt remains after enquiries, the delivery should be rejected and returned to the supplier.
What's agreed, and what isn't
'Warm to the touch' is a crude check; where the supplier ships with data loggers, the data should be reviewed. Who pays and who decides disposition should be in the supply agreement.
Can a QP use stability data to certify a batch that had a temperature excursion during import shipping?Interpretation
Possibly, under the Annex 16 'unexpected deviation' route. The MHRA GMP blog gives an example: a product labelled 'store below 25°C' reached 29°C for three days in transit, and stability data showed no issue at 30°C for three months. This could be treated as an unexpected deviation if the shipment process was designed to meet the registered conditions. If shipment conditions were not controlled, routine use of stability data to justify excursions 'would not be acceptable'.
What's agreed, and what isn't
The deviation must be investigated, the root cause found and corrected, and impact shown to be negligible. Repeat occurrences no longer count as 'unexpected'. This route applies to QP certification by manufacturers and importers, not to wholesale RPs.
Can we use mean kinetic temperature (MKT) to show an excursion didn't matter?Interpretation
Generally no. Quoting the Green Guide, the MHRA blog says MKT is only appropriate where the marketing authorisation holder gives an acceptable MKT value for the specific product and the temperature record is complete from leaving the manufacturer. In practice MKT fails where there is no complete temperature record for the consignment. Use of MKT in wholesale "without robust supporting information and methodology is therefore discouraged".
What's agreed, and what isn't
The 2020 MHRA transport blog repeats the concern, describing attempts to apply MKT to underestimate the impact of excursions. MKT may still appear in manufacturer stability justifications; the point is that a wholesaler cannot use it on its own to excuse poor control.
How quickly must a customer send back a fridge item for us to consider returning it to stock?Interpretation
The MHRA blog sets out MHRA guidance on returns. For non-defective refrigerated products returned from an unlicensed site, the return should be completed within 24 hours, including transport. For ambient products from an unlicensed site, the limit is five days. For returns from a licensed WDA site, a pragmatic approach applies, but the RP or authorised person must show 'full knowledge' of storage, including transport, throughout.
What's agreed, and what isn't
This is the MHRA position for GB. EU GDP 6.3 gives 'for example 10 days' for returns from customers without a wholesale authorisation, but that is not the UK expectation; go beyond 24 hours (refrigerated) or five days (ambient) only if agreed with the GDP Inspectorate in writing. The COVID-19 10-day allowance was temporary. For cold chain items, documented evidence of storage throughout is needed whatever the time limit.
Is it acceptable to accept a load after an excursion if the stock is probably fine?Interpretation
The MHRA transport QRM blog says it is 'rare to find sound scientific justification' for accepting a load after an excursion. It notes that manufacturer stability information is often not directly comparable to the excursion. It says the most common reason for acceptance is commercial, which may put patients at risk and undermines risk management. The acceptable range is the product's labelled storage conditions.
What's agreed, and what isn't
This is inspector commentary, not a ban; release after an excursion remains possible with product-specific evidence from the marketing authorisation holder and an RP decision. The blog also says risk assessment 'should not be used' to justify an unsuitable practice (see also the 2020 COVID GDP blog).
Our clinic room recorded over 30 °C. Do we have to destroy the stock?Interpretation
Not necessarily. An RPS case study describes a clinic that recorded temperatures above 30 °C with no clear action plan. The trust bought data loggers that calculate mean kinetic temperature, which gives the average exposure over 24 hours. Because the MKT stayed below 25 °C, the medicines did not need to be destroyed or have their expiry dates shortened.
What's agreed, and what isn't
MKT needs continuous logger data, not min/max readings. The 2015 NHS Pharmaceutical QA Committee document adds that the peak must stay below 40 °C. Persistent highs still need fixing.
Our vet practice fridge records show temperatures above 8°C. What should we do?Interpretation
VMD says recording alone is not enough: investigate the excursion, checking whether the thermometer is working, whether the equipment has a fault, and how long the medicines may have been exposed. Where product integrity is in doubt, contact the manufacturer early and follow their advice on use or disposal, and dispose of any product showing visible deterioration. Vaccines are particularly sensitive and are usually unusable if frozen or exposed to more than 8°C, but check with the manufacturer.
What's agreed, and what isn't
Inspectors report finding diligently completed records that show out-of-range temperatures with no action taken. A fridge running out of range probably means most of its contents are compromised.
Annex 1 gives fixed requalification intervals for cleanrooms. Do they apply to our cold rooms too?Guidance
No. Annex 1, 4.32 sets a maximum of 6 months between requalifications for grade A and B areas and 12 months for grade C and D, covering tests such as particle counts and pressure differentials. Those intervals are for classified cleanrooms. Storage areas, cold rooms and chambers fall under Annex 15, which asks for evaluation "at an appropriate frequency" with any fixed period justified (4.1, 4.2).
What's agreed, and what isn't
Because Annex 15 sets no number for storage, your requalification interval is a decision you write down and defend, usually from the risk of the stored product and the trend of the continuous monitoring data.
Do our stability chambers have to be qualified and monitored like any other equipment?Guidance
Yes. Chapter 6, 6.29 says equipment used for the ongoing stability programme, "stability chambers among others", should be qualified and maintained following Chapter 3 and Annex 15. The stability protocol states the storage conditions, using the standard ICH conditions consistent with the label (6.30), and out-of-specification results or significant atypical trends must be investigated (6.35).
What's agreed, and what isn't
ICH Q1A(R2) adds that the actual temperature and humidity should be monitored during stability storage, and that excursions beyond tolerance for more than 24 hours go in the study report. Normally at least one batch a year of each strength and primary pack goes on stability (6.32), so a chamber failure can touch years of data.
Do refrigerated vans have to be temperature mapped?Guidance
Yes, if temperature-controlled vehicles are used. EU GDP 9.4 says temperature mapping under representative conditions should be carried out and should take account of seasonal variations, and the monitoring equipment should be maintained and calibrated. For temperature-sensitive products, qualified equipment (thermal packaging, temperature-controlled containers or vehicles) should be used between manufacturer, wholesaler and customer.
What's agreed, and what isn't
No method, duration or re-mapping interval is specified. 'Seasonal variations' is generally read as summer and winter mapping, but the guideline does not say so. Customers can ask for evidence that products stayed within their temperature conditions, and you should be able to provide it.
Do we have to temperature map a storage area before we start putting medicines in it?Guidance
Yes. EU GDP 3.2.1 says an initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. The permanent monitoring devices should then be placed according to the mapping results, in the areas that experience the extremes of fluctuation. Mapping should be repeated according to a risk assessment or whenever significant modifications are made to the facility or the temperature-controlling equipment.
What's agreed, and what isn't
The guideline does not say how to map, how many sensors to use, how long to run it, or a fixed re-mapping interval; these are left to the company's risk assessment. 'Representative conditions' is not defined, which is why MHRA inspectors have also expected loaded and seasonal mapping (see the MHRA mapping blog).
Do we need to temperature map our medicines room and fridges, and how is it done?Guidance
SPS describes mapping as placing calibrated data loggers throughout an area to check every point is suitable and to decide where permanent sensors go. It is usual to use 8 to 25 loggers in an ambient room. In a full-size fridge, put one in each corner of the top and bottom shelves plus one in the middle. Mapping usually runs for at least 48 hours, covering busy and quiet periods. Initial ambient mapping should be done in both summer and winter. Fridges should be mapped full, and new fridges mapped empty first to get a baseline.
What's agreed, and what isn't
SPS makes re-mapping frequency risk-based and sets no fixed interval. Ambient rooms with no structural or HVAC changes need mapping less often than fridges or cold rooms holding high-cost drugs. Small GP practices and care homes rarely map in practice, and SPS does not say mapping is mandatory for them.
Do we need to test how long our cold room holds temperature in a power cut?Guidance
WHO says qualification of a new temperature-controlled store should show how long temperatures stay within limits after a power failure (holdover time) and how long they take to recover once power returns, as well as recovery after a typical door opening. Supplement 7 describes running the test until an excursion occurs, or for a fixed period such as two hours. It recommends doing this during OQ while the store is empty, because the test can cause an excursion. For cold rooms there are usually no set acceptance criteria; the results feed into emergency planning, for example for standby generators.
What's agreed, and what isn't
Re-running holdover tests on a loaded store puts stock at risk, so most sites rely on the original OQ data unless the equipment changes. WHO also expects monitoring to keep working during power failures, and wireless sensors to buffer data during outages.
Does Annex 15 require temperature mapping of our cold rooms and stability chambers?Guidance
Annex 15 never uses the word "mapping". It requires facilities, equipment and utilities to be qualified through a lifecycle (URS, DQ, IQ, OQ, PQ), with OQ testing upper and lower operating limits or worst-case conditions (3.11) and PQ under normal operating conditions (3.14). For a temperature-controlled space, a mapping study is the usual way to show those things: that the whole volume holds its range, empty and loaded.
What's agreed, and what isn't
Mapping as a word comes from EU GDP 3.2.1 (map before use, then on risk or after change) and, in sterile manufacture, from Annex 1 for autoclave loads (8.64 and 8.65). Chapter 6, 6.29 says stability chambers must be qualified to Chapter 3 and Annex 15. So the requirement for a chamber is qualification; mapping is the evidence most inspectors expect to see.
How long should a mapping study run, and is seasonal mapping needed for a cold room?Guidance
WHO Supplement 8 says there is no formal time limit. Typically ambient warehouses should be mapped for at least seven consecutive days, including five working days and a weekend. Cold rooms and freezer rooms should be mapped for 24 to 72 hours, or longer if justified. Rooms with duplicate refrigeration units should be mapped with each unit running on its own. Where areas are affected by seasonal variation, two studies (warmest and coldest seasons) may be needed, but this is "typically" not necessary for cold rooms and freezer rooms.
What's agreed, and what isn't
The European Commission GDP Q&A says mapping should be done in different seasons without exempting cold rooms. A refrigerated room in an uncontrolled or external building may still be affected by the seasons, so assess your own situation. Supplement 8 also suggests products should return within limits within 30 minutes of a defined door opening, where door openings are part of the study.
How many data loggers do we need for a mapping study and where do we put them?Guidance
WHO Supplement 8 suggests a risk-based grid with loggers every 5 to 10 metres along the length and width (up to 20 to 30 metres in very large facilities), positioned where products are actually stored. Where ceilings are 3.6 m or lower, place loggers at low, middle and high level (for example floor, 1.2 m and 3.0 m). For taller spaces use vertical arrays, for example at 0.3, 1.8, 3.6 and 5.4 m in a 6 m store. Loggers should be one type per study, sample at the same interval of 1 to 15 minutes, start at the same time, and hold a valid 3-point calibration with error within ±0.5°C.
What's agreed, and what isn't
The grid is guidance, not a rule; WHO itself says a risk-based approach can define locations. High-bay racking is singled out as prone to stratification and needs mapping over its full working height.
How often do we have to requalify a temperature-controlled room or chamber at a manufacturing site?Guidance
EU GMP Annex 15 sets no fixed interval. It says facilities, equipment and systems should be evaluated "at an appropriate frequency" to confirm they remain in control. Where requalification is done on a time basis, the period should be justified and the evaluation criteria defined, and the possibility of small changes building up over time should be assessed.
What's agreed, and what isn't
WHO Technical Supplement 8 gives an example of remapping every three years, but says a periodic re-evaluation may be more appropriate where several fixed monitors provide continuous data. Whatever interval you choose, document the rationale.
How often should we repeat temperature mapping of a storage area?Guidance
WHO Supplement 8 says new temperature-controlled areas must be mapped before use. After that, depending on the monitoring strategy, periodic remapping may be needed, "for example, every three years". Where several fixed monitors give continuous data, a periodic re-evaluation of system performance since the initial mapping may be more appropriate. Mapping should also be repeated after significant changes (for example to loading, airflow, refrigeration equipment or set point) and may be justified when monitoring shows unexplained variability.
What's agreed, and what isn't
Three years is an example, not a requirement. EU GMP Annex 15 also leaves the interval to a justified, risk-based choice. Inspectors mainly look for a documented trigger list and rationale.
In Ireland, does the HPRA expect an ambient warehouse to be mapped in both summer and winter, and empty and full?Guidance
Yes. The HPRA temperature guide (IA-G0011) says warehouses should be mapped in the empty and full states and that mapping should be performed during both summer and winter to assess worst-case conditions. Mapping should be repeated after significant modification to the premises, changes in stock layout or changes to the heating system, and areas such as skylights and controlled drug cabinets should be included.
What's agreed, and what isn't
The guide does not set a fixed re-mapping interval (e.g. every X years); re-mapping is trigger-based. It also flags turning heating off overnight or at weekends as something to consider. The EU GDP Guidelines themselves only say mapping should be done 'under representative conditions'; the explicit summer/winter and empty/full wording is HPRA elaboration.
Our Irish storage area is tiny. Do we need a full temperature mapping study?Guidance
The HPRA GDP guide says an initial mapping exercise must be performed and documented for areas greater than a few square metres; for room-temperature areas smaller than that, a risk assessment can be used instead. Continuous monitoring probes should then be placed according to the mapping or risk assessment in all storage areas, including pick-face, quarantine and returns, with at least a max/min thermometer read and reset daily.
What's agreed, and what isn't
This mirrors EU GDP 3.2.1, which has the same 'few square meters' concession; the HPRA wording makes mapping a 'must' above that size. 'A few square metres' is not defined numerically. The concession applies to room-temperature areas only; IA-G0011 still expects mapping to inform probe locations in small fridges. Products with no labelled storage condition may be stored at temperatures not exceeding 30°C according to the same guide.
Our store is just a small room at room temperature - do we need a full mapping study?Guidance
EU GDP 3.2.1 makes a specific allowance: for small premises of a few square metres at room temperature, an assessment of potential risks (for example heaters) should be conducted and temperature monitors placed accordingly. This is offered instead of the formal mapping exercise described for larger storage areas.
What's agreed, and what isn't
'A few square metres' is not defined. The MHRA's 2016 mapping blog, aimed at small storage areas and small fridges, still describes a mapping exercise with calibrated probes, so many inspectors will expect some recorded data, not only a desk-based risk assessment. The allowance covers room-temperature premises only, not fridges or cold rooms. Check with your inspector if in doubt.
We moved racking and replaced a compressor in a qualified cold room. Do we need to requalify?Guidance
Annex 15 says changes should be assessed through change control for their impact on product quality, validation, calibration and maintenance, with a plan for any necessary verification or requalification (11.4), and the effectiveness of the change evaluated afterwards (11.7). Requalification at a fixed period must be justified, and gradual change over time should be considered (4.2).
What's agreed, and what isn't
Annex 15 does not list triggers. The HPRA temperature guide, which includes manufacturers in its scope, gives repair or replacement of the refrigeration unit, layout changes and set-point changes as re-mapping triggers, and the MHRA's 2015 GMP deficiency data cite a storage room reconfigured with no assessment of the effect on its mapping.
We're applying for a new WDA(H) - do we need mapping done before the inspection?Guidance
Yes. MHRA Guidance Note 6 says applicants must be inspection-ready at the point of application. That includes being able to show a temperature mapping exercise of the proposed wholesale area with a clear methodology, and evidence of transport validation. Applicants should also give details of ambient and cold chain storage, transport arrangements, computerised systems and business contingency plans.
What's agreed, and what isn't
GN6 does not define what counts as adequate transport validation. For small applicants using couriers, this usually means courier qualification plus packaging or lane qualification evidence. The MHRA mapping blog notes that new applicants are often unclear about mapping expectations.
What qualification stages does a new cold room, freezer or stability chamber need under GMP?Guidance
Annex 15 sets a lifecycle from the user requirements specification (URS) to retirement. Design qualification checks the design against the URS (3.3). Installation qualification covers installation checks, supplier manuals and calibration of instrumentation (3.9). Operational qualification tests the upper and lower operating limits or worst case (3.11). Performance qualification shows performance under normal operating conditions with worst-case loads (3.14). Tests done at the factory or site acceptance can be credited if transport and installation do not affect the function (3.6).
What's agreed, and what isn't
WHO Supplement 7 describes the same four phases for temperature-controlled stores: OQ empty (alarm tests, empty mapping, door-opening and power-failure tests) and PQ loaded. The monitoring system on the chamber is a separate computerised system, validated under Annex 11.
When does the HPRA expect a walk-in cold room or large fridge to be re-mapped?Guidance
IA-G0011 says large refrigerators and walk-in cold rooms should be mapped on installation in the empty and full states, with an ambient probe outside the unit. Re-mapping is expected after significant changes such as repair or replacement of the refrigeration unit, changes to internal layout, changes to set points, and changes to how duty/back-up condensers are run, including swapping which is main and which is back-up; if units are routinely rotated, both should be in the mapping study. Moving a small fridge may also require re-mapping.
What's agreed, and what isn't
These are specific triggers that go further in detail than the EU GDP text. The guide's wording varies in strength: re-mapping after a change to how duty/back-up condensers are run 'is required', while moving a fridge 'may' require it, and most other triggers use 'should'. None of it is a legal requirement. No fixed periodic re-mapping frequency is given.
When we qualify a cold room or freezer, which alarm tests should be in the OQ?Guidance
WHO Supplement 7 says OQ is normally done empty and includes alarm tests: at least one high and one low alarm test, plus door-open alarms, and every notification route (sounder, strobe, remote or SaaS service, SMS or phone) needs to be tested. OQ also covers empty mapping for at least 24 hours, door-opening recovery and a power-failure holdover test.
What's agreed, and what isn't
WHO writes for storage and distribution, but the supplement covers ultra-low freezers, freezers, cold rooms and controlled ambient stores, and its steps match the Annex 15 OQ. Do not start PQ until OQ deviations are closed (2.6).
Do our production areas and WIP stores need temperature mapping, or is monitoring enough?Interpretation
An MHRA group manager, replying on the Inspectorate blog in 2016, said the normal expectation is temperature monitoring only within production areas, but mapping may be required if the product is temperature sensitive. Mapping of WIP or intermediate storage may also be needed to show the routine monitoring positions are representative of the worst case.
What's agreed, and what isn't
This is an inspector's reply, not guidance. EU GMP itself asks for production areas to have temperature control appropriate to the products (Chapter 3, 3.12) and for environmental controls to be recorded (Chapter 5, 5.43). Write the decision, and the data behind it, into your qualification file.
How often should we re-map, and what is the RP's role?Interpretation
The MHRA blog says the risk assessment from mapping should define and justify how often future mapping is done, and should be reviewed regularly, for example during self-inspection. Mapping should be repeated for seasonal variation and if the storage area is reconfigured. The RP should be involved in the whole mapping process, aware of the findings and recommendations, supervise routine daily min/max monitoring, and be consulted on any temperature excursion.
What's agreed, and what isn't
No fixed re-mapping interval is set by EU GDP or this blog. Annual or summer/winter mapping is a common industry convention, not an MHRA rule. Be ready to justify whatever interval you choose.
How should a small wholesaler actually carry out a temperature mapping exercise?Interpretation
The MHRA mapping blog says to map before stock is stored if possible, using dummy product in empty fridges, freezers and cold stores, and to repeat the mapping when fully stocked and to cover seasonal variation. Cover the highest point of storage and problem areas such as heaters, lighting, windows, doors, loading bays and mezzanines. Include CD rooms, packing, returns and quarantine areas. Use enough calibrated probes for the size of the area, then risk-assess the data to place permanent probes at hot and cold spots.
What's agreed, and what isn't
The blog notes that EU GDP requires mapping but 'does not state how this should be done'. It gives no probe numbers, grid spacing or duration. Larger sites often use specialist third parties. The blog does not answer how long each mapping run should last.
If a contractor carries out our temperature mapping, is their report enough?Interpretation
No; the company has to review and approve it. MHRA's 2015 GMP deficiency examples include mapping of production and warehouse areas by a contractor that "had not been approved by the company". Other findings were a retention sample store with no temperature logger nearby, a drug storage room reconfigured without assessing the impact on the existing mapping, and laboratory sample and standard storage areas with no temperature recording.
What's agreed, and what isn't
WHO Supplement 8 likewise says a protocol prepared by a third party should be authorised by the responsible person in the commissioning organisation. These are deficiency examples, not formal guidance.
In a GLP lab, do refrigerators with data capture need a user requirement specification and mapping?Interpretation
In its 2016 laboratories symposium Q&A, the MHRA said any equipment using electronic data capture is within scope of OECD GLP guidance document No. 17 on computerised systems. The level of validation depends on complexity. Where a computerised system captures or monitors data, an assessment of fitness for use is expected, including a specification covering temperature range and alarms. The refrigerator should be fit for purpose and able to deliver the required performance, which 'may require equipment validation such as temperature mapping'.
What's agreed, and what isn't
The answer is framed for GLP test facilities. Mapping is described as possibly required, not mandatory, so the extent should be risk-based and documented.
Is there an industry standard for how often to remap a controlled temperature chamber?Interpretation
Not a fixed one. ISPE's Good Practice Guide on controlled temperature chambers (second edition, December 2021) moved to a risk-based periodic review, judged on the risk of failing to keep a uniform temperature and how critical the stored product is, "rather than a standard, one-size-fits-all time span". It also covers mapping with load effects, using the data to find worst-case locations and the number of monitoring sensors, and adds ultra-low freezers.
What's agreed, and what isn't
ISPE guides are licensed industry guidance, not regulation; this paraphrases ISPE's public description. It agrees with Annex 15 (an appropriate, justified frequency) and with WHO, which gives three years only as an example.
What does 'initial temperature mapping' actually involve, and does it have to cover summer and winter?Interpretation
The Commission's Q&A describes initial mapping as placing sensors at the points a risk analysis shows to be most critical (for example different heights, near a sunny window, next to doors), measuring over a period, and then putting the monitoring sensors where the greatest fluctuation occurred. It says mapping should be done in different seasons, when the highest and lowest temperatures are reached.
What's agreed, and what isn't
WHO Technical Supplement 8 agrees on two-season mapping for areas affected by seasonal variation, but says it is "typically" not necessary for cold rooms and freezer rooms. The Commission Q&A does not make that exception. For ambient warehouses, plan for both seasons. For refrigerated rooms, justify your choice.
Is EN 12830 a legal requirement for our temperature recorders?Law
Only for quick-frozen food. Commission Regulation (EC) No 37/2005 requires the means of transport, warehousing and storage of quick-frozen foodstuffs to have recording instruments monitoring air temperature, and Article 2(2) says that from 1 January 2006 those instruments must comply with EN 12830, EN 13485 and EN 13486. The food operator must keep documents showing they conform, and keep dated temperature records for at least a year. It remains law in Great Britain as assimilated law.
What's agreed, and what isn't
No UK or EU medicines law names EN 12830. For medicines, vaccines, blood and laboratories it is voluntary: NHS SPS asks for data loggers compliant with BS EN 12830, while EU GDP, the MHRA, the HPRA and WHO set outcomes (accuracy, calibration, recording) instead. Retail display cabinets and local distribution of quick-frozen food need only a visible thermometer. Our EN 12830 guide in this library explains what the standard covers.
Can our monitoring use the fridge or cold room's own control probe?Guidance
No. For manufacturers, wholesalers and transporters, the HPRA says recording probes should be independent of controlling probes, and placed where mapping found the greatest temperature variability. WHO TRS 961 Annex 9 (clause 4.5.1) says the same from the other side, and this is the part that applies to hospital, laboratory and blood settings: control sensors should be independent of the temperature monitoring system. If the controller's sensor drifts or fails, a monitor that shares it reads normally while the product warms.
What's agreed, and what isn't
IA-G0011's scope (section 1) is manufacturers, wholesalers, transporters and API manufacturers, so the HPRA point is not attributed to hospitals, labs or blood services. EU GDP 3.3 treats equipment that controls and equipment that monitors as two things to calibrate, but does not itself say they must be separate. EN 12830, the recorder standard, opens its requirements with the same principle: the recorder's measurement must be independent of the one used to control the refrigerating system. A built-in display usually shows the controller's sensor, which is why the Green Book also asks for a separate max/min thermometer.
Do research tissue freezers and room-temperature stores need temperature monitoring under an HTA licence?Guidance
Yes. Research standard PFE2(c) requires storage conditions to be monitored, recorded and acted on when required, and the HTA says material stored at ambient temperature still needs monitoring. Temperature alarms should be regularly tested and periodically challenged manually. Freezers should carry signs showing the alarm set points, and a remote alarm and call-out system may be needed where storage is critical. Liquid nitrogen dewar checks and filling should be documented, and PFE2(d) requires a documented contingency plan for storage failure.
What's agreed, and what isn't
'Where storage is critical' is left to the Designated Individual to judge. The HTA gives no numeric ranges because research storage temperatures depend on the material and protocol.
Do we have to trend our temperature and environmental monitoring data, or just check it?Guidance
Chapter 6, 6.9 says some kinds of data, including environmental controls, "should be recorded in a manner permitting trend evaluation", and out-of-trend data investigated. QC must also have environmental monitoring data and calibration records to hand (6.7). Chapter 4 requires procedures and records for environmental monitoring and calibration (4.29) and logbooks for critical equipment (4.31).
What's agreed, and what isn't
A daily tick that a reading was in range does not allow trend evaluation. A continuous electronic record does, provided someone reviews it. Annex 1 goes further for sterile sites (alarm events evaluated for trends, 5.2).
Do we need temperature alarms, and do they have to be tested?Guidance
Yes. EU GDP 3.3 says appropriate alarm systems should be in place to alert when there are excursions from pre-defined storage conditions. Alarm levels should be set appropriately and alarms regularly tested to make sure they work.
What's agreed, and what isn't
The guideline does not define test frequency, alarm delay, or out-of-hours response. The MHRA's 2020 transport blog gave an example where poorly set alarms failed to trigger, giving false assurance that stock was in range. Alarm set points, delays and call-out arrangements should be justified in your own procedures.
Does Annex 1 require temperature and humidity monitoring in cleanrooms, and how does ISO 14644 fit?Guidance
Annex 1 includes temperature, relative humidity and other specific characteristics in the environmental monitoring programme (9.2), and says they should be controlled within ranges that suit the product, process and personnel (9.6). Cleanroom qualification includes a temperature measurement test and a relative humidity test, with the ISO 14644 series as the reference (4.25), and the number of particle sampling locations comes from ISO 14644-1 (4.28).
What's agreed, and what isn't
Annex 1 separates qualification from routine monitoring (4.24). ISO 14644-1 classifies air cleanliness by particle concentration and ISO 14644-2 sets the particle monitoring plan; particle counting is a separate discipline from storage temperature monitoring.
Does Annex 1 say anything about how monitoring systems are specified and how alarms are reviewed?Guidance
Yes. Annex 1, 5.2 says equipment monitoring requirements should be defined in user requirements specifications during early design and confirmed during qualification, and process and equipment alarm events should be acknowledged and evaluated for trends. Monitoring procedures must define the approach to trending, including consecutive excursions from alert levels (9.11), and action-limit breaches need a root cause investigation and product impact assessment (9.13).
What's agreed, and what isn't
Annex 1 has no data integrity or audit trail wording and does not mention calibration; for those, use Annex 11 and Chapter 4. Environmental monitoring and trend data for classified areas are reviewed as part of batch certification (10.10).
Does the HPRA temperature guide apply to manufacturers in Ireland, or only wholesalers?Guidance
Its scope covers human and veterinary medicinal product manufacturers, wholesalers and transporters in Ireland, and manufacturers of APIs. It says a continuous temperature monitoring system is required for the storage of medicinal products, recording probes should be independent of controlling probes and placed at the greatest variability found by mapping, warehouses mapped empty and full in summer and winter, and probes calibrated at least annually at a minimum of three points.
What's agreed, and what isn't
Its legal basis and much of its wording are written for wholesale (it cites the wholesale regulations and the RP), so present it as HPRA temperature guidance that includes manufacturers, not as a GMP guideline. Irish manufacturers' legal duty to follow GMP is in S.I. No. 539/2007, regulation 10.
How accurate do our temperature sensors need to be, and where should the monitoring probe go?Guidance
WHO says monitoring sensors should be accurate to ±0.5°C or better for electronic devices, and ±1°C for alcohol, bimetal or vapour-pressure thermometers. They should be placed where the greatest temperature variability is expected within the qualified storage volume, but positioned to be minimally affected by brief events like door opening. Control sensors (the thermostat) should be independent of the monitoring system. WHO Supplement 6 says ambient areas should be monitored at the seasonal hot and cold spots found in mapping, and cold rooms at the operational hot and cold spots.
What's agreed, and what isn't
WHO Supplement 6 adds that if a spot near a door causes frequent alarms that cannot be fixed, products should not be stored there at all, rather than moving the probe to hide it. 'Worst case but not affected by door opening' can be a real tension in small walk-in rooms.
How often do fridge temperatures have to be checked and recorded?Guidance
SPS says temperatures should be monitored continuously, and min/max readings checked, recorded and reset at least once a day. It adds that "an independent daily check" should confirm the checks and resets were done. Data loggers should also be reviewed periodically to pick up trends such as gradual drift.
What's agreed, and what isn't
Sources differ on frequency. SPS says at least daily. RPS guidance and the GP vaccination enhanced service (2024–26, now expired) say each working day. The SW ICARS toolkit says at least once, and ideally twice, each working day. None of these sources says who should check at weekends. SPS's answer to closed periods is continuous monitoring with remote alerts.
How often should temperatures be checked and how often should a logger record?Guidance
WHO model guidance says temperature devices, traces or electronic records should be checked manually at least twice a day, morning and evening, seven days a week including public holidays. Cold rooms, freezer rooms and temperature-controlled rooms should record at least six times per hour (every 10 minutes) for each sensor position, and keep running during a power failure. Refrigerators and freezers should preferably be on a multipoint system or battery logger at the same frequency; a max/min thermometer is the least preferred option. Records should be reviewed monthly to act on systematic excursions.
What's agreed, and what isn't
This is international reference guidance aimed mainly at wholesale and larger stores. UK primary care, pharmacy and vaccine guidance sets its own reading frequencies, so smaller UK settings should follow the guidance for their sector. A twice-daily check, seven days a week, is hard to achieve in sites that are closed at weekends without remote alerting.
How often should we check the room temperature where medicines are stored?Guidance
SPS says min/max recorders are the minimum requirement in medicines storage locations. The 2015 NHS Pharmaceutical QA Committee guidance on clinical areas says all medicines storage areas should be routinely monitored. Min/max readings should be taken at least daily and the thermometer reset after each reading, with the thermometer placed in the worst-case location found by mapping or risk assessment.
What's agreed, and what isn't
Neither SPS page states a separate frequency for ambient areas. The daily figure comes from the 2015 NHS PQA document, which applies to NHS Trust wards and clinical areas. The SPS daily min/max wording sits under fridge-oriented alert guidance. Care homes and GP practices often adopt daily checks by analogy rather than because a national source requires them.
How often should we test that our temperature alarms actually work?Guidance
WHO model guidance says the functionality of temperature and humidity alarms should be checked at least once every six months at the designated set points, with records kept. WHO Supplement 7 describes the qualification alarm test as one high and one low temperature alarm test, plus any event alarm such as door-open, recording settings and confirming the alarm activated (sounder, strobe, remote alert or message).
What's agreed, and what isn't
Testing should include the full notification route, such as SMS or call-out to on-call staff, not just the local sounder. The six-month interval is WHO's minimum; UK regulators do not set a single figure in the sources reviewed here.
In a sterile suite, what does Annex 1 say about monitoring pressure differentials and setting alarm delays?Guidance
Annex 1 (2022), 4.16 says air pressure differences identified as critical should be continuously monitored and recorded, with a warning system that instantly indicates and warns operators of any failure. The warning should not be overridden without assessment, and "where alarm delays are set, these should be assessed and justified within the CCS" (the contamination control strategy). Other pressure differences are recorded at regular intervals.
What's agreed, and what isn't
This is the only place Annex 1 mentions alarm delays. It sets no figure, so the delay is yours to justify. Cleanroom pressure and particle monitoring is usually a dedicated environmental monitoring system rather than a storage monitoring system.
In Northern Ireland, how often should GP practices check vaccine fridges and how long should records be kept?Guidance
PHA guidance says vaccine fridge temperatures should be checked and documented at least daily and preferably twice daily (start and end of the working day), recording date, time, and minimum, maximum and current temperatures, then resetting the thermometer, including after periods of high activity. Fridges with an audible alarm are recommended and the alarm should be tested regularly. Daily temperature records should be kept for five years. Each fridge should have a unique identifier recorded on its temperature and servicing records, and satellite fridges must not be overlooked.
What's agreed, and what isn't
Twice-daily checking and five-year retention are stricter than the CQC (England) mythbuster's once per working day. This is NI regional guidance from the PHA, not an inspectorate (RQIA) standard.
Is a min/max thermometer enough, or do we need a data logger or a remote monitoring system?Guidance
SPS calls min/max recorders the minimum requirement in medicines storage locations. It warns that manual reading and resetting is error-prone and cannot show when, or for how long, an excursion happened. Data loggers record at short intervals. SPS wants them compliant with BS EN 12830, with a display, a large memory (for example 5-minute intervals for 6 months or more) and evidence of calibration. Networked monitoring systems remove manual downloads and let staff review several areas remotely.
What's agreed, and what isn't
SPS's "Monitoring the storage temperature of medicines" article says stronger systems are justified for medicines that are highly temperature-sensitive, hard to replace, expensive or held in bulk. The choice is risk-based, not fixed by setting.
Is the ICH stability guideline changing, and does the draft change what we monitor?Guidance
ICH endorsed a consolidated Q1 guideline as a Step 2 draft on 11 April 2025, to supersede Q1A to Q1F and Q5C. Its section 7.1 repeats the Q1A(R2) wording almost word for word: the equipment should control the condition within the defined ranges and actual temperature and humidity should be monitored, with the same rules on door spikes, equipment failures and excursions over 24 hours.
What's agreed, and what isn't
It is a draft. The ICH work plan targeted Step 4 for November 2026, and Q1A(R2) remains the effective text until adoption. New in the draft: a 30 °C/75% RH long-term option by climatic zone, and a requirement that each excursion outside a labelling claim is handled in the quality system.
Is there a contractual requirement for GP practices to record vaccine fridge temperatures?Guidance
Yes, under the NHS England GP COVID-19 vaccination enhanced service for 2024–26, now expired; check the specification in force. It required every fridge storing vaccine to have a thermometer recording maximum and minimum temperatures. Readings had to be recorded "on all working days", with appropriate action when they are outside range. Fridges must also have enough space and airflow, with vaccine types separated.
What's agreed, and what isn't
This specification covered 1 September 2024 to 31 March 2026. Check the specification currently in force. The wording requires working days only, so weekend gaps are not a contract breach. They are still an excursion-detection risk that loggers are meant to cover.
Our GP practice is closed at weekends. How do we know the vaccine fridge was fine over Saturday and Sunday?Guidance
The NHS England South West ICARS toolkit says data loggers should be downloaded weekly and checked against 2-8 °C. It says this is ideally done on first entering the premises after the weekend and before the first vaccines of the week are given. Loggers set to 5-minute intervals let the exact length of a breach be worked out. A logger does not replace the daily manual read, record and reset on each working day.
What's agreed, and what isn't
This is regional NHS England guidance for GP practices in the South West, but it is built on Green Book chapter 3. It also recommends fridge checks in the closing routine before weekends and bank holidays, and cross-cover so checks continue when staff are absent.
Should the alarm probe go right by the door, since that is where the temperature swings most?Guidance
No. WHO Technical Supplement 6 (section 2.5.2) says monitors "should not be placed in areas where transient events such as a door opening may affect the monitoring and generate an abnormally high number of alarms". Ambient stores are monitored at the seasonal hot and cold spots found in mapping, and cold rooms and freezer rooms at the operational hot and cold spots. If door openings trigger out-of-range alarms too often and that cannot be fixed technically or operationally, for example by limiting door openings, the area should not be used to store product at all.
What's agreed, and what isn't
The HPRA reaches the same place by a different route: IA-G0011 section 10 says probes should be in an appropriate load simulator so that transient rises when the doors are opened during picking do not trigger alarms. EU GDP 3.2.1 and the MHRA mapping blog say only that monitors go at the extremes found by mapping, which some sites read as the door threshold. Record why each probe is where it is, and how it is buffered.
Should the fridge probe measure the air or be in a buffered bottle?Guidance
SPS recommends at least one of each in a fridge or freezer. An air sensor gives early warning, because air warms before the product does. A load sensor sits in a mock product and shows the medicine's likely temperature. SPS suggests propylene glycol as the buffer, in a volume matching the smallest medicine stored. For ambient areas, an air sensor alone is generally suitable.
What's agreed, and what isn't
An air probe alone tends to alarm on every door opening, while a buffered probe alone can hide short but real air excursions. The 2015 NHS Pharmaceutical QA Committee document suggested a water bottle as the buffer, whereas current SPS guidance names propylene glycol.
What alarm and monitoring arrangements does the HTA expect on body store fridges and freezers?Guidance
Standard PFE2(e) requires fridge and freezer units to be alarmed, with alarms tested regularly to confirm they trigger at the upper and lower set limits. Alarm tests should include the call-out procedure and be recorded. The HTA advises a remote alarm for units in areas not permanently staffed, such as maternity, so staff are alerted out of hours. Staff should know the acceptable ranges and trigger points. Under PFE2(f), temperatures must be monitored regularly in a way that shows trends and the extent of variation.
What's agreed, and what isn't
The HTA does not set an alarm-test frequency or monitoring interval. Trend analysis effectively requires logged data rather than spot readings. Storage units elsewhere in the hospital that hold bodies or tissue under the licence are in scope.
What data logger settings and reviews does Northern Ireland guidance expect for vaccine fridges?Guidance
PHA says data loggers should be used as a back-up so extra information is available after a cold chain breach. Set them to five-minute intervals and have the Vaccine Controller check them weekly against the paper min/max readings, with data accessible to more than one person. A logger does not replace paper copies of the daily or twice-daily readings. An annual audit of cold chain procedures is recommended, and the audit checklist asks whether thermometers are calibrated or replaced annually.
What's agreed, and what isn't
Five-minute logging is much finer than the 15-30 minutes the VMD suggests for vet practices, and the CQC (England) mythbuster gives no interval. The annual calibration point appears only as an audit question, not as a stated requirement.
What does RPS guidance say about checking fridge temperatures outside pharmacies, for example on wards, in GP surgeries or in ambulances?Guidance
The RPS Professional Guidance on the Safe and Secure Handling of Medicines (Appendix A) says fridges and freezers must be designed for medicines. Their temperature is monitored "on each working day using a calibrated maximum-minimum thermometer" or another approved device, with a recording system. Staff who read temperatures must be trained to record them correctly and to act on out-of-range readings.
What's agreed, and what isn't
"Each working day" is less than SPS's "at least once a day" plus continuous monitoring, and leaves weekends to risk assessment. The RPS page is now marked as archived, although the 2018 guidance remains the published version.
What does the HPRA expect from temperature alarms?Guidance
Where possible, monitoring systems should have alarms that immediately notify relevant personnel. Alarm set points may include alert and action limits (alert limits set so preventive action can be taken before an excursion), and provision should be made for an out-of-hours response. Alarms should be checked regularly at their set points without exposing product to out-of-specification temperatures, with records kept, and alarm nominees trained.
What's agreed, and what isn't
Probes may be placed in a load simulator to avoid nuisance alarms from door openings. For cold rooms, section 3.3 says 'Alarms should be fitted to the unit'. The freezer section (3.4) expects alarms on large and walk-in units and smaller units holding at-risk product; for small fridges an alarm is 'if fitted'. The guide gives no specific test frequency.
What does the RCVS Practice Standards Scheme require for medicines temperature monitoring?Guidance
Core standard 10.1.6 (Small Animal) requires monitoring and recording of maximum and minimum temperatures wherever medicines are stored, including consulting rooms, prep rooms, fridges and vehicles. Where readings fall outside range, there must be evidence of an action plan to correct the deviation and deal with affected medicines, and practices should consider alarms. Without an alarm, and for min/max thermometers, checks must be made daily, and assessors will ask to see weekly written records. Temperature-sensitive medicines should ideally go out in vehicles only 'by use', in a cool box or fridge unit whose suitability is demonstrated.
What's agreed, and what isn't
Equivalent standards sit in the Farm Animal and Equine modules under different numbers. PSS is voluntary accreditation, but the underlying duty to store per the SPC is now law under VMR Schedule 3 paragraph 3E.
What is 'read, record, reset, react' for vaccine fridges?Guidance
The SPS COVID-19 vaccine fridge quick reference guide (December 2020) sets out four steps. Read max, min and current temperatures at the start and end of each day and whenever the fridge is opened. Record them on a signed log. Reset the max/min thermometer after each reading and after dealing with alarms. React immediately to any reading outside 2-8 °C by checking power, door and probe position, moving and quarantining stock, and reporting to the clinical supervisor. It also asks for monitoring a new fridge for a day before stocking it, and for 24 hours after relocation.
What's agreed, and what isn't
This was written for the COVID-19 programme, and SPS archived its related COVID-19 checklist in 2024. Its start-and-end-of-day reads are stricter than the 'once each working day' minimum elsewhere. The four Rs come from Green Book chapter 3, which the NHS England SW ICARS toolkit also follows.
What monitoring and records does the Red Book expect for blood component storage areas?Guidance
Storage areas must run within a specified temperature range. Areas and equipment should be validated before routine use and checked for calibration to a documented schedule after that. A permanent continuous record of storage temperatures should be made, reviewed and stored, along with a log of alarm events describing the corrective action taken. Written procedures should cover validating and monitoring storage conditions, authorised access, segregation by status (quarantine, non-conforming, returned, stock) and stock rotation.
What's agreed, and what isn't
The Red Book sets no calibration frequency or alarm set points; these are left to local validation. It is written for UK blood services, but hospital transfusion laboratories commonly apply it.
What should we look for when choosing a continuous temperature monitoring system?Guidance
WHO Supplement 6 recommends starting with a user requirements specification and choosing between an in-house hosted system and supplier-hosted SaaS. Wireless sensors should buffer data during network or power outages, sensors should be calibrated annually with a plan that avoids disrupting monitoring, and the system should have audit trails, secured data, different user levels, SOPs covering installation, use, backup and decommissioning, and full IQ/OQ/PQ. Alarm limits should be set only by authorised users, with automatic alerts by email or SMS and alert schedules for weekends and holidays. Round-the-clock technical support should be in the contract.
What's agreed, and what isn't
The supplement says that under SaaS the supplier ensures system maintenance and qualification. MHRA does not accept vendor validation in isolation from your intended use, so the user still has to verify. WHO notes that a simple 30-day temperature recorder may be enough for small peripheral stores.
What temperature should a fridge alarm be set to, and should it have a delay?Guidance
SPS suggests setting the alarm just inside the limit. For a fridge with an 8 °C maximum, a 7.5 °C threshold lets staff respond before an excursion happens. A short delay can stop alarms for normal door openings, but SPS says it should be "as short a period as practically possible". Alarms should never be permanently silenceable, and if silenced they should re-sound after a set period, such as 10 minutes, if the fridge is still out of range.
What's agreed, and what isn't
SPS does not give a delay value in minutes, and it does not say how often alarms should be tested. Local policy needs to set both.
Who will know if the fridge fails overnight or at the weekend when nobody is in the building?Guidance
SPS notes that audible alarms can be missed out of hours or when nobody is nearby. Networked alerts by SMS, email or telephone reach users even when no staff are present, and SPS calls them "the most robust means of alerting users". Alert systems should keep a record of alerts. If they cannot, staff should record alerts manually.
What's agreed, and what isn't
SPS does not set an escalation chain or name who should respond. The 2015 NHS Pharmaceutical QA Committee document says areas staffed for only part of the week may need tighter control and monitoring than areas that are always occupied. Weekend cover is a local risk decision.
Do dental practices have to monitor the temperature of medicines storage?Interpretation
Yes. CQC dental mythbuster 35 says inspectors should see medicines stored securely, in an appropriate environment that follows the manufacturer's recommendations, with temperatures 'monitored regularly' and appropriate action taken if medicines are not stored correctly. Expiry dates of medicines and medical equipment should also be checked regularly. The example of good practice is staff regularly monitoring temperature to keep medicines within the manufacturer's limits.
What's agreed, and what isn't
The mythbuster does not define 'regularly' or say whether ambient storage and fridges are treated differently. CQC dental inspection reports often ask for daily fridge recording, but that is not written into the mythbuster.
How many temperature probes do we need in our storage area?Interpretation
The European Commission's GDP Q&A says the number of probes and where they go depend on a risk analysis of the site, and placement should agree with the mapping results. It gives no fixed number.
What's agreed, and what isn't
WHO gives more concrete starting points. For walk-in spaces the number of monitoring points depends on size and on variations seen during mapping. For a refrigerator or freezer at least one monitoring point is needed, and WHO notes some regulators want two (warmest and coldest points). The Q&A states it is not legally binding.
How often does CQC expect GP practices to read and record vaccine fridge temperatures?Interpretation
At least once every day of the working week, on a standard form, recording the current, maximum and minimum temperatures, signed by the person taking the reading, and resetting the thermometer after each reading (the Green Book 'four Rs': Read, Record, Reset, React). Staff must act immediately if the temperature is outside +2 to +8°C. CQC says practices should ideally use a second thermometer independent of the fridge's integral one, both to cross-check accuracy and to keep monitoring if the power to the fridge fails.
What's agreed, and what isn't
'Each working day' means weekends and closures are covered only by the min/max reading taken on the next working day, so a long excursion over a bank holiday is detected late. Northern Ireland's PHA guidance goes further, recommending twice-daily checks. CQC's care home page asks for at least once a day, not once a working day.
How often should we read the fridge thermometer, and what do we do if it's out of range?Interpretation
The MHRA blog says refrigerated stock should be monitored daily with a calibrated min/max device that has a calibration certificate. Records should show any deviation and the corrective action taken. As best practice, take a further reading later the same day to show the deviation was transient and the temperature is back in range. The RP should be informed of any deviation and should routinely review and sign off the records.
What's agreed, and what isn't
'Daily' is the minimum the blog describes; continuous electronic monitoring is now common and EU GDP expects alarms. The blog also expects records to be free from alterations and a trained deputy to cover absences. The blog does not say how to judge whether stock is still usable; that needs RP assessment and manufacturer stability data.
How should a care home record medicines fridge temperatures to satisfy CQC?Interpretation
Record the fridge temperature at least once a day, noting the minimum, maximum and current temperatures from a min/max thermometer (CQC prefers an inbuilt digital thermometer), and reset it after each reading so the record shows variation between readings. Staff must understand how to read and reset it, know what to do if the fridge is out of range, and record actions taken, including asking a pharmacist whether the medicines are still safe to use. Make sure the probe cable does not interfere with the door seal.
What's agreed, and what isn't
CQC asks for 'at least once a day', which in a 24/7 care home means every day including weekends. That is stricter than the GP 'each working day' wording. CQC does not specify calibration or record retention for care homes.
If we have a data logger in the vaccine fridge, do we still need to do daily manual readings?Interpretation
Yes. CQC says that even with a data logger you must still read and record the integral thermometer's minimum, maximum and current temperatures and reset the min/max thermometer each working day. It warns that checking a logger only weekly or monthly risks missing cold chain breaches and using vaccines that were stored out of range. It also asks whether an alarm could clear itself once the temperature returns to range without anyone investigating. CQC sees loggers as useful for detailed information after a failure such as a power cut.
What's agreed, and what isn't
The mythbuster does not say whether a continuously monitored, alarmed remote system with an audit trail could replace manual readings. As written, it expects the daily manual record regardless, so check with your ICB before dropping paper records. VMD and NI PHA guidance take the same 'logger plus daily check' position.
Is the fridge's built-in display enough, or do we need a second thermometer?Interpretation
An RPS case study describes a vaccine fridge whose built-in display showed normal readings while an independent thermometer read 0 °C. The display was faulty and all the vaccines were destroyed. Afterwards, every fridge was given a second, external thermometer, and both readings are recorded daily. The external thermometer also keeps working during a power failure.
What's agreed, and what isn't
This is an illustrative case study, not a requirement. The SW ICARS toolkit and the archived 2020 SPS COVID-19 vaccine fridge guide both recommend two thermometers. SPS's current general guidance asks for at least one air sensor and one load sensor.
What do MHRA GMP inspectors find wrong with alarms and humidity in manufacturing areas?Interpretation
MHRA's 2016 GMP deficiency examples include temperature alarms in manufacturing areas set at 18 °C to 26 °C when some materials and products required 2 °C to 25 °C; temperature and humidity captured only twice a day as spot readings with no max/min data; capsule shells not stored at the manufacturer's recommended 35 to 65% RH in the warehouse; a warehouse receiving area with no temperature monitoring against its 32 °C limit; and users permitted to change the default audit trail.
What's agreed, and what isn't
Examples from one year's dosage-form inspections, published to support self-inspection. They show the pattern: limits that do not match the product, readings that cannot show what happened between checks, and areas nobody thought to monitor.
What monitoring does a walk-in cold room need compared with a small fridge?Interpretation
Quoting the Green Guide, the MHRA blog says large commercial fridges and walk-in cold rooms should be monitored by an electronic temperature recording device that measures load temperature in one or more places, depending on size. Alarms should be fitted for power outages as well as temperature excursions. Condensate from chillers should not collect inside, and as much maintenance as possible should be done from outside the unit.
What's agreed, and what isn't
The number of sensors is not specified; it should follow mapping results. The 2016 MHRA deficiency data cited a walk-in fridge with dirt build-up around the fans and no cleaning schedule, so cleaning records are part of compliance.
What temperatures should we set our alarms at?Interpretation
The Commission's Q&A says alarm settings should be chosen to guarantee a timely alert to staff when conditions move outside the predefined storage conditions. It does not give specific values.
What's agreed, and what isn't
WHO Supplement 6 suggests configuring both pre-alarms (triggered before the temperature goes out of range) and alarms after it goes out of range, with only authorised users able to set limits. MHRA's 2016 GMP deficiency data shows what goes wrong: alarms were set at 18 to 26°C for materials needing 2 to 25°C, so excursions between 25 and 26°C would not be flagged. Any alarm delay used to avoid nuisance alarms from door openings should be justified.
What thermometer or data logger set-up does the VMD expect in a vet practice, and how often should it be checked?Interpretation
As a minimum the VMD recommends a digital thermometer showing current, minimum and maximum temperatures. For all refrigerated storage, including vehicle fridges and vaccine chillers, record min and max daily and reset after each reading. Ambient areas should be recorded daily, though this can drop to weekly where temperatures are consistently stable. Data loggers must be set to flag excursions; for fridges, download and review them at least weekly, with logging roughly every 15-30 minutes. They do not replace daily checks that the device is working and no alert has fired.
What's agreed, and what isn't
The VMD notes that min/max readings cannot show how long an excursion lasted, which is an argument for loggers. It suggests insulating cabled probes to mimic product temperature and choosing a calibrated system, but gives no calibration interval. Using a third-party monitoring service does not transfer responsibility for responding to alerts.
A monitoring probe failed its calibration. What does GMP say we must do about past readings?Guidance
Part II says critical monitoring equipment should be calibrated to written procedures and a schedule (5.30), with standards traceable to certified standards where they exist (5.31), and calibration status known and verifiable (5.33). Instruments that fail should not be used (5.34), and deviations should be investigated to see whether they could have affected quality since the last successful calibration (5.35).
What's agreed, and what isn't
Part II is written for APIs, but the same look-back is what any GMP inspector will ask about. The HPRA temperature guide, which includes manufacturers in scope, says a failed calibration should trigger a review of previous readings and that calibration should cover the entire monitoring system.
How often do fridge thermometers and probes need calibrating, and to what standard?Guidance
SPS says sensors should be calibrated annually to ±0.5 °C by a UKAS-accredited service, and the certificates kept. Calibration can be 2-point or 3-point. SPS says 3-point calibration is "a requirement in departments operating under an MHRA licence". That is SPS's reading: the MHRA and EU GDP texts are risk-based and set no number of points, while the HPRA asks for at least three.
What's agreed, and what isn't
Sources differ on this. The NHS England SW ICARS GP toolkit asks for yearly servicing and calibration and also a monthly check of the fridge reading against an independently powered external thermometer. The RPS guidance only says the thermometer should be calibrated. A simple monthly cross-check against a second thermometer is not the same as UKAS-traceable calibration.
How often do temperature monitoring devices need calibrating, and what does traceable mean?Guidance
WHO says temperature control and monitoring devices should be calibrated against a certified, traceable reference standard at least once a year unless otherwise justified, and calibration should show accuracy across the whole range the device is used over. Single-use devices supplied with a manufacturer's calibration certificate do not need recalibrating. For mapping studies, WHO Supplement 8 expects loggers with a 3-point traceable calibration certificate (one point below, one in the middle and one above the range) with error no more than ±0.5°C at each point.
What's agreed, and what isn't
'Unless otherwise justified' leaves room for longer intervals backed by stability data on the sensor. MHRA's 2016 GDP deficiency data includes a warehouse thermometer that "had not been calibrated across the operating range". Calibrating at one point only is a known inspection finding.
How often do we need to calibrate the thermometers and loggers in our warehouse?Guidance
EU GDP 3.3 does not set a fixed interval: equipment used to control or monitor the storage environment should be calibrated at defined intervals based on a risk and reliability assessment. Calibration should be traceable to a national or international measurement standard. Repair, maintenance and calibration should be done in a way that does not compromise product integrity, and records should be kept.
What's agreed, and what isn't
Storage calibration is risk-based, but transport monitoring equipment has a stated minimum of at least once a year (EU GDP 9.2). Many companies use annual calibration for storage too for consistency. The 2016 MHRA deficiency data cited a warehouse thermometer that had not been calibrated across its operating range, so the calibration range matters as well as the date.
How often does EU GMP say our temperature probes and recorders must be calibrated?Guidance
Chapter 3, paragraph 3.41 says measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods, with adequate records kept. It does not set the interval. Annex 15 adds that installation qualification includes calibration of instrumentation (3.9), and change control must consider the effect of a change on calibration (11.4).
What's agreed, and what isn't
An MHRA inspector replying on the Inspectorate blog in 2018 said "the general expectation is that equipment should be calibrated annually", which is interpretation rather than a GMP clause. GDP is firmer for transport: at least once a year (9.2). Whatever interval you choose, justify it from the instrument's history and risk, as ICH Q9(R1) Annex II.4 suggests for calibration schedules.
How often must temperature loggers used in vans and shipping boxes be calibrated?Guidance
EU GDP 9.2 says equipment used to monitor temperature during transport in vehicles or containers should be maintained and calibrated at regular intervals, at least once a year. Section 9.4 repeats that monitoring equipment in temperature-controlled vehicles should be maintained and calibrated at regular intervals.
What's agreed, and what isn't
This is one of the few fixed frequencies in EU GDP; storage monitoring calibration is risk-based instead. Single-use loggers are usually covered by the supplier's calibration certificate, which should be checked as part of supplier qualification.
We can't get our thermometers to an accredited calibration lab. Is an ice-water check acceptable?Guidance
WHO Supplement 10 describes an ice-point (ice-water bath) check for use where a full 3-point calibration by an accredited laboratory is not possible. It checks accuracy at one temperature (0°C) only. It needs a calibrated reference thermometer more accurate than the device under test, distilled-water ice and careful technique. A passing device is labelled as valid for one year (unless the manufacturer or regulator says otherwise). A failing device is adjusted, has its sensor replaced, or is withdrawn, with a non-conformity report. Results should be kept at least until the next check, preferably for three years.
What's agreed, and what isn't
WHO presents this as a fallback with stated limitations, not an equivalent to accredited multi-point calibration. For UK GDP or GMP sites, where accredited calibration is readily available, a single-point ice check is unlikely to satisfy an inspector as the only calibration, though it is a useful intermediate check.
What calibration does the HPRA expect for temperature monitoring probes?Guidance
Probes should be calibrated at least annually against a traceable reference, at a minimum of three points across the range of use (examples given: 0, 15 and 30°C for ambient warehouse probes; -10, 0 and 10°C for fridge probes). Calibration should cover the entire monitoring system (probes, receiver, display), certificates should state the method and be reviewed and approved by the wholesaler, and a failed calibration should trigger a review of previous readings.
What's agreed, and what isn't
Auxiliary calibrated probes should be used so storage areas stay monitored during calibration; serial numbers and certificates of these should be kept. Recording probes should have an accuracy of at least +/-0.5°C and be independent of control probes. In IA-G0011 section 3.3 the ±0.5 °C figure applies to large-volume cold storage only; the HPRA's 2022 mapping slides (slide 9) repeat it generally.
How long must batch records for an investigational product be kept?Law
At least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used. For Great Britain the period comes from Commission Directive 2003/94/EC, Article 9(1), which the UK clinical trials regulations still reference; Article 9(2) adds that electronic systems must be validated, data backed up and audit trails maintained. For Northern Ireland, Delegated Regulation 2017/1569, Article 8(3) sets the same five years.
What's agreed, and what isn't
Sample retention for IMPs is two years after the last trial ends (2017/1569, Article 11). Keep the storage and shipping temperature records that support a batch's certification for at least as long as its batch documentation.
Can our QA lead or the person who reviews the data also be the administrator of the monitoring system?Guidance
The MHRA's GxP data integrity guidance says shared logins or generic user access should not be used for systems generating, amending or storing GxP data, and that system administrator rights "should not be assigned to individuals with a direct interest in the data (data generation, data review or approval)" (6.16). Audit trails identified as required should be switched on and users should not be able to amend or switch them off (6.13).
What's agreed, and what isn't
Administrator access should be kept to the fewest people possible for the size of the organisation, each with unique credentials so their actions show in the audit trail. In a cloud system the supplier usually holds platform administration; your own administrator roles still need the same separation.
Can we delete or ignore a temperature reading that we think was a faulty sensor spike?Guidance
Data may only be excluded where valid scientific justification shows it is not representative of what was measured. The justification must be documented and considered during data review. All data, even if excluded, should be kept with the original data set in a form that lets someone confirm the decision to exclude was valid.
What's agreed, and what isn't
In practice a suspected sensor fault should be handled as a deviation: investigate it, check the sensor (and calibration), and record the conclusion against the reading rather than removing it. MHRA does not give temperature-specific examples here.
Can we scan our paper temperature record sheets and then destroy the paper originals?Guidance
Yes, if the scan is a verified true copy. MHRA allows true copies to be kept in place of the original (for example a scan of a paper record) where a documented system verifies and records the integrity of the copy, by a dated signature or a validated process. Paper data may be kept using a validated scanning process, provided a documented process ensures the outcome is a true copy. Organisations should consider any risk of destroying the originals.
What's agreed, and what isn't
The guidance does not say how to verify each scan. A 'validated scanning process' is defined as one with added controls so each page need not be checked by a person. Without that, someone needs to check and sign each copy. Make sure the scan is legible for the whole retention period and keeps signatures, dates and corrections visible.
Does a simple digital fridge thermometer need validating as a computerised system, or is calibration enough?Guidance
MHRA says simple electronic devices with no configurable software and no electronic data retention, and it names thermometers as an example, "may only require calibration". More complex systems need validation for their intended purpose, and the effort grows with configurability, user intervention and data lifecycle risk. Where basic equipment does store data but overwrites it after a set volume, the data should be reviewed periodically, reconciled with paper records where needed, and extracted electronically where the device supports it.
What's agreed, and what isn't
A data logger with download software, configurable alarms or a cloud dashboard is not a 'simple' device in this sense, and validation expectations apply. MHRA also warns not to overlook apparently simple systems where data could be manipulated or repeated without detection.
Does an electronic temperature monitoring system need validating under HPRA GDP guidance?Guidance
The HPRA GDP guide says a computerised system relating to GDP processes should be shown, through validation or verification, to achieve results accurately, consistently and reproducibly before use, with the level of validation set by risk (complexity, bespoke vs off-the-shelf, customisation). It points to EU GMP Annex 11 for further information, and equipment qualification protocols should be approved by the RP.
What's agreed, and what isn't
The guide does not single out temperature monitoring systems or give data integrity (ALCOA+) detail; no HPRA GDP-specific data integrity guide was found. IA-G0011 adds that records must be retrievable, allow excursions to be identified, and that reviews must be recorded.
Does our electronic temperature monitoring system need an audit trail, and do we have to review it?Guidance
Where a computerised system captures, stores or reports raw data, MHRA expects it to keep audit trails showing all changes and deletions (who, what, when and why) while keeping the original data. Audit trails identified by risk assessment as required should be switched on, and users should not be able to amend or turn them off. Routine data review should include a documented audit trail review where risk assessment requires it, and this can be done by a validated exception report. It need not cover every log-on or keystroke.
What's agreed, and what isn't
For legacy systems without an audit trail, alternative controls such as an SOP and log books are allowed if shown to be effective, but MHRA expects demonstrated progress towards a compliant system and may cite a deficiency if remediation is not timely. The guidance does not set a review frequency; that comes from your own risk assessment. For a monitoring system, relevant entries include alarm limit changes, sensor reassignment, acknowledgements and any edits to readings.
Does our electronic temperature monitoring system need to be validated, and how long do we keep the data?Guidance
EU GDP 3.3.1 says a computerised system should be shown, through validation or verification, to achieve the desired results accurately, consistently and reproducibly before it is used. Data should be protected against accidental or unauthorised change, checked periodically for accessibility, and backed up regularly. Backups should be kept for the period in national legislation but at least five years, at a separate and secure location.
What's agreed, and what isn't
The guideline also expects a written description of the system and defined procedures for system failure, including data restoration. It does not prescribe audit trail features; the MHRA GxP data integrity guidance gives more detail. Cloud-hosted systems still need the separate, secure backup location to be demonstrable.
How long do we have to keep temperature records?Guidance
EU GDP chapter 4 says documents should be kept for the period stated in national legislation but at least five years, and records should be made at the time each operation is undertaken. Chapter 3.3.1 applies the same five-year minimum to backups of computerised system data.
What's agreed, and what isn't
Five years is a minimum; manufacturer, contract or other legal requirements may require longer. Records must be contemporaneous, so filling gaps afterwards is a data integrity failure (the 2016 MHRA deficiency data cites an RP who added fabricated readings).
How long do we need to keep fridge and room temperature records?Guidance
SPS's pharmacy records retention guidance, republished in September 2026, gives at least 5 years for medicine storage temperature records. This covers fridge and ambient readings, excursions, monitoring-system downloads and calibration records, and is based on GDP record-retention advice. For vaccines, it also gives at least 5 years for temperature logs and 11 years for refrigerator maintenance logs.
What's agreed, and what isn't
The Green Book (chapter 3), which SPS quotes, sets a floor of at least 1 year but says records should cover the full storage history of products held. Because vaccine shelf lives can be 4 years or more, SPS says 5 years generally covers it. The RPS guidance and NICE SC1 set no retention period. Care homes and GP practices often keep records for 1-2 years, which is shorter than the SPS figure.
How long must a manufacturer keep storage temperature records?Guidance
Chapter 4 does not name temperature records. Batch documentation must be kept for one year after batch expiry or at least five years after QP certification, whichever is longer (4.11). Critical documentation, including raw data relating to validation or stability that supports the marketing authorisation, must be kept while the authorisation is in force (4.12). Records must stay intact and readable for the whole period (4.1, 4.10).
What's agreed, and what isn't
Storage records that support a batch's release fall in practice with its batch documentation, and chamber records behind stability data with the MA-supporting raw data; this is a reading of 4.11 and 4.12, not their words. Longer periods may apply to products such as ATMPs (4.11). For investigational products the batch documentation period is five years after the last trial using the batch ends.
How long must a tissue establishment keep temperature monitoring records for tissues and cells used in patient treatment?Guidance
The HTA Guide to Quality and Safety Assurance says raw data such as temperature monitoring printouts must be kept for at least 10 years in their original format, and records critical to quality and safety for at least 10 years after expiry, clinical use or disposal. All critical equipment must have set operational limits, such as temperature, and be monitored, with calibration against a traceable standard where available and procedures for malfunction or failure. Transport conditions, including temperature and time limits, must be specified and validated, and shipping containers validated for their purpose.
What's agreed, and what isn't
After 10 years the guide allows raw data to be stored in another format. For electronic monitoring systems, 'original format' means the native data with its audit trail, which needs planning for system migrations.
How long must an API manufacturer keep records, including storage records?Guidance
Part II, 6.13 says records should be kept for at least one year after the batch's expiry date. For APIs with retest dates, records should be kept for at least three years after the batch is completely distributed.
What's agreed, and what isn't
Part II also requires controls to prevent omissions in data, for example "system turned off and data not captured" (5.43), and a back-up system where a breakdown would mean permanent loss of records (5.48). Both apply directly to a monitoring system.
How long should we keep temperature records?Guidance
WHO's model guidance gives two figures. Clause 9.3.1 says temperature records should be kept for at least one year after the end of the shelf life of the stored product, or as long as national law requires. Clause 9.2.3 says records generally should be kept for the minimum period under local law, but not less than three years. WHO Supplement 15 says downloaded transport logger data should in most cases be kept at least three years in a retrievable, non-volatile format.
What's agreed, and what isn't
The WHO document is inconsistent with itself, and national law takes precedence. In the UK, check the retention period required by your licence, GDP guidance or sector guidance. EMA's GMP Q&A on Annex 11 confirms electronic records have the same retention requirements as paper.
Once our GMP temperature monitoring system is validated, do we need to do anything else to keep it validated?Guidance
Yes. EU GMP Annex 11 requires computerised systems to be periodically evaluated to confirm they remain valid, looking at things like deviations, incidents, upgrades, performance, security and validation status. Backups should be made regularly and restoration checked, stored data checked for accessibility and readability, and audit trails reviewed regularly. Changes, including configuration changes, must go through a defined change procedure, and it should be possible to get clear printed copies of stored data.
What's agreed, and what isn't
Annex 11 sets no fixed interval. The EMA Q&A says the period for re-evaluation should be based on the system's criticality. Annex 11 is EU GMP guidance that continues to be applied in UK GMP. A revised Annex 11 has been in draft, so check for updates.
Our logger software backs up to a server every night. Does that count as archiving our temperature records?Guidance
No. MHRA distinguishes backup (a copy of current data for disaster recovery) from archive (long-term protected retention), and says backups "do not replace the need for the long term, retention of data". Backup and recovery should be validated and periodically tested, and each backup checked to confirm it worked. Archived records must be protected from undetected change or deletion and stay retrievable and readable, with metadata, throughout the retention period. Before a system is decommissioned, its records should be archived under a documented strategy, for example by keeping the software in a virtual environment or migrating to a format that keeps as much of the true copy as possible.
What's agreed, and what isn't
The MHRA guidance does not set a retention period for temperature data; it defers to the legislative requirements for each GXP area. Plan for what happens to historical logger data when you change monitoring supplier.
Our monitoring gateway was offline for a weekend and readings are missing. Is that a GMP problem?Guidance
It can be. Part II says computerised systems should have controls to prevent omissions in data, such as a system turned off and data not captured, and a record of any data change (5.43); where a breakdown could permanently lose records, a back-up system should be provided (5.48). Annex 11 asks that data stay accessible throughout the retention period and backups be checked for restoration (7.1, 7.2).
What's agreed, and what isn't
A gap is a deviation to investigate: when it started, whether the sensors buffered readings and backfilled them, and whether the product was at risk. A monitoring system that alarms when a sensor or gateway goes offline turns a silent gap into a prompt to act.
Our temperature monitoring system is cloud-hosted by the supplier. What does the MHRA expect us to have in place?Guidance
MHRA says you should understand the service provided, who owns the data, and how it is retrieved, retained and secured, including where the data is physically held and which laws apply there. Responsibilities should be set out in a technical agreement or contract that guarantees timely access to data, metadata and audit trails for you and for the authorities on request, and covers archiving and readability for the whole retention period. Arrangements must exist to restore the system to its validated state, business continuity should be in the contract and tested, and the need to audit the provider should be based on risk.
What's agreed, and what isn't
WHO Technical Supplement 6 describes software-as-a-service as an arrangement where the supplier "ensures the system maintenance and qualification". MHRA is clear that the regulated company keeps responsibility for the data and for validation for its intended use. Check what happens to your records if the contract ends or the supplier fails.
Our temperature monitoring system stores readings electronically. Can we just print and file the weekly reports instead of keeping the electronic data?Guidance
MHRA says raw data is the first capture of information, and where it was captured electronically in a dynamic state "paper copies cannot be considered as 'raw data'". Where a system can store data dynamically, it is not appropriate to keep static (printed or manual) records in preference to the electronic data. Retaining only a static record is possible only where it can be justified that it keeps the integrity of the original, including verified copies of raw data, metadata, audit trails and configuration settings, plus a documented check that the printouts are accurate. MHRA notes this approach is "likely to be demanding in its administration".
What's agreed, and what isn't
WHO Technical Supplement 15 (transport monitoring) lists printed hard copies as an acceptable retention format for downloaded logger data, so the WHO position is looser than MHRA's. For UK-regulated activity the MHRA expectation is the one inspectors apply. Printouts remain useful for review and signing, as long as the electronic record is kept as the original.
The monitoring system supplier gave us a validation pack. Is that enough to show the system is validated?Guidance
Not on its own. MHRA says computerised systems must be validated for their intended purpose, and "the acceptance of vendor-supplied validation data in isolation" from your configuration and intended use is not acceptable. Vendor testing done away from your process and IT setup is likely to be functional verification only, and may not meet performance qualification requirements. Vendor documents can feed into your validation, but you still need to show the system works as configured at your site.
What's agreed, and what isn't
How much site testing is needed depends on risk and complexity (MHRA section 4.3). WHO Supplement 6 expects installed monitoring systems to be qualified through IQ, OQ and PQ after a commissioning period. For SaaS systems the supplier may do much of the work, but the user still has to confirm the system meets its own requirements.
We are a small operation. How much data integrity control does the MHRA expect for our temperature records?Guidance
MHRA describes its guidance as a minimum expectation but asks for a risk-based approach where effort is "commensurate with the risk and impact" of a data integrity failure. Organisations are not expected to check data forensically as a routine, and a data integrity risk assessment is suggested to map processes and controls. Switching from electronic to paper, or back, does not remove the need for appropriate controls. The guidance encourages talking to the MHRA where your approach differs from what it describes.
What's agreed, and what isn't
The guidance does not cover medical devices. It is written for all MHRA-regulated GXP areas, so the examples are not always temperature-specific; you have to apply the principles to your own monitoring set-up. The MHRA Inspectorate blog (9 March 2018) confirmed the guide covers GDP as well as GMP and supersedes the March 2015 GMP-only guide.
We read the fridge display and write the temperature on a paper chart. Is that acceptable from a data integrity point of view?Guidance
Yes. A paper record of a manual observation can be the original record, but MHRA expects the risk to be assessed, and depending on how critical the data is, a second check or another way of capturing it may be justified. Records should be available where the work happens so people do not jot readings informally and copy them later, and blank forms should be controlled (for example numbered and reconciled). Where readings are transcribed from one record to another, the transcription should be checked by a second person or a validated system.
What's agreed, and what isn't
WHO TRS 1033 Annex 4 also gives writing a logger reading on a room log sheet as an example of an original record. If the device itself stores the data electronically, MHRA's view is that the stored electronic data is the raw data, and the paper chart is a secondary record.
We use a mix of paper logs and an electronic logger. Is a hybrid system acceptable?Guidance
Hybrid systems are allowed, but MHRA says it should be clearly documented what makes up the whole data set, and all records in that set should be reviewed and kept. MHRA also expects more data review for hybrid systems, because they are vulnerable to changes that cannot be attributed to anyone. WHO's data integrity guideline says where hybrid systems are used, even for an interim period, the risks should be assessed with documented mitigating controls, and replacing them "should be a priority with a documented CAPA plan".
What's agreed, and what isn't
The WHO view (replace hybrids as a priority) is firmer than MHRA's (control and review them). For small sites with a fridge logger plus a daily paper check, documenting which record is the original and how the two are linked is the practical minimum.
What should our documented review of temperature records actually include?Guidance
MHRA expects a procedure for reviewing and approving data, including a risk-based review of relevant metadata and audit trails. The review should be documented with a positive statement of whether or not issues were found, the date of the review and the reviewer's signature. A procedure should say what happens when an error or omission is found, with corrections that keep the original visible and traceable. Where you rely on summary reports from another organisation, such as a courier's or 3PL's temperature summary, MHRA says summaries are limited and you should assess the provider's data integrity controls first.
What's agreed, and what isn't
The guidance does not set how often reviews happen. WHO TRS 961 Annex 9 suggests reviewing temperature records monthly, with checks at least twice daily. UK sector guidance sets its own frequencies, so check those for your setting.
Can we keep temperature records in a shared spreadsheet or report alarms over WhatsApp?Interpretation
The MHRA data integrity blog for GDP says multi-user spreadsheets can make it impossible to show who made an entry, when, or whether it was overwritten. It suggests restricting spreadsheets to non-critical data, or locking and version-controlling them. It says a wholesaler's proposal to use WhatsApp for quality-critical event reporting was refused because it could not meet data integrity requirements. It also gives an example where an inspector could not trust ambient min/max records because the thermometer was uncalibrated and staff did not know how to use it.
What's agreed, and what isn't
Computerised systems are encouraged if appropriately qualified and controlled. The MHRA GxP Data Integrity guidance (2018) gives the detailed ALCOA expectations. The MHRA's 2016 GDP deficiency data shows what happens otherwise: gaps in temperature records that an RP admitted filling with fabricated readings, entries in pencil, unsigned records and unapproved corrections, all cited as major deficiencies. Missed readings should be recorded as missed, never back-filled. The blog also says paper temperature records transcribed into an electronic system should be checked by a person of appropriate seniority.
Is it acceptable to record or analyse temperature data in an Excel spreadsheet?Interpretation
EMA's GMP Q&A says spreadsheet templates should be checked for accuracy and version controlled, and formulas and files should be secured so they are not accidentally overwritten. Entry of the wrong data type should be blocked or flagged, and 'boundary checks' are encouraged. Formal validation is required at least for spreadsheets with custom code such as macros, and formulas should be verified. MHRA adds that electronic worksheets should be version controlled, and that data transfer into a worksheet should be validated and audit-trailed.
What's agreed, and what isn't
None of these sources says directly whether a spreadsheet can be the primary temperature record. Ordinary spreadsheets usually lack individual logins and audit trails, which MHRA expects for GXP data (sections 6.13 and 6.16). Using one as the master record therefore needs extra controls and justification. Using it to analyse data exported from a logger is easier to defend, as long as the original logger data is kept.
What data integrity failures in temperature records have MHRA GDP inspectors found at wholesalers?Interpretation
MHRA's 2016 GDP deficiency data includes a Responsible Person who admitted adding fabricated readings to fill gaps in temperature records. Other findings were records made in pencil, unsigned temperature records and unapproved corrections. Equipment findings included a warehouse thermometer not calibrated across its operating range, an ambient-area thermometer installed so readings were not taken from the calibrated probe, uncalibrated equipment used to monitor transport, and mapping that did not establish where to place thermometers.
What's agreed, and what isn't
The report is published to support self-inspection. It shows that inspectors treat gaps and fabricated or unattributed entries as serious. A missed reading should be recorded and explained as a gap, never filled in afterwards.
What GAMP category is a cloud temperature monitoring system?Interpretation
GAMP 5 (second edition, 2022) groups software as infrastructure, tools and IT services, standard system components, configured components, and custom applications and components (categories 1, 3, 4 and 5; category 2 has not been used since 2008). ISPE says categorisation applies to the components that make up a system and the categories should be viewed as a continuum. A configurable monitoring platform is usually assessed as configured (category 4), with any custom interfaces higher.
What's agreed, and what isn't
ISPE stresses that the software category is only one factor in a risk-based approach; the risk of each function to product and data matters more. GAMP 5 is industry guidance, not regulation, though inspectors know it well. Its second edition adds guidance on assessing cloud service providers and SaaS.
Can vaccines left over in the cool box at the end of a clinic go back in the fridge?Guidance
The SW ICARS toolkit says yes, provided there is evidence the cold chain was maintained. Returned vaccines should be labelled and used at the earliest opportunity. It says to use only validated medical-grade cool boxes and packs with validated min/max thermometers, to record temperatures at the start and end of each session, and to take only enough vaccine for the session. Domestic cool boxes should not be used.
What's agreed, and what isn't
The evidence for return comes from the session temperature record, so a cool box without a min/max reading cannot show the cold chain was maintained.
Can vaccines taken out to a clinic or care home be returned to the practice fridge if unused (Northern Ireland)?Guidance
Under PHA guidance, vaccines leaving the practice should be removed from the fridge just before transfer and carried only in a validated cool box with a min/max thermometer or data logger, with those readings kept for five years alongside the records of the fridge they return to. If they stayed within 2-8°C they can go back into the fridge marked 'use first'. Vaccines should not make the trip from fridge to clinic more than once. Cool packs must not touch the vaccines, and cool boxes should be kept out of direct sunlight.
What's agreed, and what isn't
The guidance assumes short transit times (it refers to under two hours for home or care home visits). For longer journeys, validate the cool box against the manufacturer's stated hold time.
Can we qualify insulated cold-chain shippers in an environmental chamber for Irish distribution?Guidance
IA-G0011 states that qualification should use actual transport conditions and that chamber studies 'are not considered to be reflective of actual conditions'. Studies should send containers with loggers to the furthest delivery location, cover seasonal extremes (possibly separate summer and winter pack-outs), full and empty loads, and any door openings during delivery. The time of packing, not dispatch, should be recorded so receivers can confirm receipt within the validated time.
What's agreed, and what isn't
Ice-pack conditioning and re-freezing times should form part of validation, and freezers used for ice packs are subject to the same qualification as product freezers. The position on chamber studies is a notable HPRA-specific statement; it is not wording from the EU GDP Guidelines.
Can we use an ordinary picnic cool box and ice packs to move fridge medicines between sites?Guidance
No. SPS says domestic cool boxes should not be used. Use cold chain containers and cool packs from a recognised medical supplier, whose manufacturer confirms the temperature range and hold time. Cool packs are usually conditioned at 2-8 °C. Ice packs or frozen packs are generally avoided unless the manufacturer specifically recommends them, because of the freezing risk. Medicines must not touch the packs. Cool boxes always need monitoring, preferably with a calibrated data logger, otherwise a min/max thermometer.
What's agreed, and what isn't
Cool boxes should be re-validated in line with the manufacturer's instructions under simulated real use. With refrigerated vehicles, the logistics provider must give per-delivery temperature evidence instead. Mini-fridges on vehicle power must be validated for engine-off periods on multi-stop routes. SPS gives no generic maximum transit time.
Do shipments of investigational products to trial sites need temperature monitoring?Guidance
The EU guideline on sponsors' handling and shipping of IMPs (effective 1 January 2023) says temperature monitoring of transport and storage conditions is necessary, the records should be kept and evaluated at delivery, and equipment critical to keeping the required conditions in transit should be qualified. Any deviation during shipment should be recorded and formally investigated with the manufacturer.
What's agreed, and what isn't
This is the EU text, which applies in Northern Ireland. For Great Britain the 2010 Annex 13 asks for shipping to the sponsor's instructions (44) and storage records to be reviewed before transfers between sites. In practice sponsors expect the same evidence either way.
Does a haulier or courier holding medicines in transit in Ireland need a wholesale authorisation?Guidance
The HPRA's position is that storage of medicinal products for more than 48 hours during transportation, or any storage of refrigerated product regardless of time, is storage requiring that premises to hold a WDA. A carrier that does not own the product and only transports it generally does not need a WDA under the same conditions.
What's agreed, and what isn't
The wholesaling guide words the refrigerated case more softly ('may be regarded as falling within' WDA requirements), so for any cold-chain cross-dock arrangement it is worth confirming with the HPRA. Contracted transport should be audited and covered by a service level agreement that includes sub-contracting.
Does the HPRA require refrigerated vans to be temperature mapped?Guidance
Where refrigerated vehicles or containers are the primary means of environmental control, IA-G0011 says they should be validated and monitored, including mapping to find hot and cold spots under worst-case conditions (loaded to capacity, seasonal extremes) and considering door openings, power sources and breakdowns. Loads at risk of freezing should be monitored with calibrated data loggers, and single-use monitors should be qualified.
What's agreed, and what isn't
Vehicle validation is not necessary if a validated container/packaging configuration provides the primary environmental control. The guide gives no mapping frequency for vehicles.
How do we qualify a refrigerated delivery van?Guidance
WHO Supplement 11 recommends a static mapping first to find hot and cold spots in the load space. This is followed by at least four tests: maximum and minimum payload in the warmest season, and maximum and minimum payload in the coldest season, ideally on a real worst-case route with multiple drops and door openings. The vehicle can be only provisionally qualified after the first season's tests, and fully qualified once both seasons are done, unless a test chamber is used to simulate them. An alternative is full qualification of each vehicle type plus an installation qualification for each new vehicle.
What's agreed, and what isn't
Requalification is expected after significant modifications and should be considered when monitoring shows unexplained variability. WHO sets no fixed interval.
If we use a 3PL or courier, what do we need in place?Guidance
EU GDP chapter 7 requires a written contract that sets out each party's duties. The contract giver is responsible for the outsourced activity, must assess the contractor's competence, and should audit before work starts and whenever it changes, with audit frequency based on risk. The contractor must not subcontract without the contract giver's prior evaluation and approval. Chapter 9.2 adds that transport providers must be told the transport conditions for each consignment.
What's agreed, and what isn't
EU GDP 3.2 also says contracted premises should be covered by their own wholesale authorisation. The 2016 MHRA deficiency data included missing transport contracts, no audits of contract acceptors, and 3PLs allowed to subcontract without review.
Is it still allowed to use non-temperature-controlled transport when it's below 20°C outside?Guidance
This was a temporary COVID-19 flexibility. MHRA guidance from April 2020 allowed non-temperature-controlled transport when ambient temperature was below 20°C. It required 'do not refrigerate' products to be identified and shipped appropriately below 8°C, with a risk assessment and mitigation. The same guidance allowed storage equipment to be used with limited qualification, completed retrospectively, and products to be held at transit hubs for up to 96 hours without a WDA(H).
What's agreed, and what isn't
The GOV.UK page has not been formally withdrawn, but it was framed as temporary and under regular review, and the 2023 MHRA GDP symposium gave delegates an 'update on the Covid Flexibilities'. Do not rely on these flexibilities today without confirming with the GDP Inspectorate. Wholesalers using them also had to record the decision and notify Covid19.GMDP@mhra.gov.uk.
What are the rules on using ice packs or cool packs in insulated boxes?Guidance
EU GDP 9.4 says cool packs must be placed so the product does not touch them directly. Staff must be trained to assemble insulated boxes, including seasonal configurations, and on reusing cool packs. There should be a system to control reuse so that incompletely cooled packs are not used by mistake, and frozen and chilled packs should be physically segregated. Delivery of sensitive products and control of seasonal temperature variation should be in a written procedure.
What's agreed, and what isn't
EU GDP 9.3 adds that container selection should consider external temperature extremes, maximum transit time including customs, and the qualification status of the packaging. Pack-out validation is expected but its method is not specified.
What are the temperature rules for transporting blood components?Guidance
Transit containers, packing materials and procedures should be validated to keep component surface temperature within range. Routine transport temperatures should be monitored periodically, with revalidation after any change to containers, packing or procedure. Containers should be equilibrated to storage temperature before filling, not exposed beyond their validated range and time, and dead air space minimised; melting ice must not touch components. For red cells the validated surface range is 2-10°C, with 10°C acceptable between supplier and hospital on one occasion of up to 12 hours. Donations intended for platelets must not drop below 18°C on the way from the donor session.
What's agreed, and what isn't
The Red Book accepts that red cells sometimes leave the supplier before they have cooled to 4 ±2°C. In that case the 2-10°C transport range may not be achievable and local judgement applies. A 2016 JPAC change notice used different wording, so use the live online Red Book.
What does Annex 15 expect when we ship finished product from the manufacturing site?Guidance
Section 6 says products should be transported in line with the conditions in the marketing authorisation, the label or the product specification file (6.1). Routes should be defined and seasonal variation considered (6.2). A risk assessment should cover delays, failure of monitoring devices, topping up liquid nitrogen and product susceptibility (6.3), and continuous monitoring and recording of critical environmental conditions should be performed "unless otherwise justified" (6.4).
What's agreed, and what isn't
GDP then applies from dispatch: transport loggers calibrated at least once a year (GDP 9.2) and a procedure for excursions. MHRA's 2016 GMP deficiency examples include air shipments with no justification for not having a logger in every pallet.
What extra temperature controls does the MHRA expect when we ship medicines by air?Guidance
MHRA air freight guidance says aircraft hold temperature control is limited, and the 'greatest and most frequent vulnerability' is on the airport tarmac during loading and unloading. It recommends minimising tarmac time, priority ramp handling, covered storage at transit airports and thermal blankets. It also lists pre-conditioned temperature-controlled vehicles with electronic monitoring for ground legs, and cargo hold temperatures of +15°C to +25°C. The IATA Time and Temperature Sensitive label must show the external handling range, and that range must match the air waybill or service agreement.
What's agreed, and what isn't
The guidance was published as part of Brexit contingency planning (2019) and draws on WHO TRS 961 Supplements 12 and 13. Its technical content still reflects general expectations. Any variation from an airline's branded pharma service should be agreed beforehand in an SOP.
Are ordinary vans or curtain-sided trailers acceptable for ambient medicines?Interpretation
The MHRA transport QRM blog says dark solid-sided vans with no compartment cooling are more likely to get hot in summer. It says curtain-sided trailers are at high risk of both high and low temperature excursions, and of theft. It calls temperature-controlled vehicles the industry-chosen answer and expects interim risk mitigation while fleets are replaced. Other risk controls it mentions include delivering at cooler times of day in summer and outsourcing to couriers better able to control temperature.
What's agreed, and what isn't
Uncontrolled vehicles are not banned outright; the expectation is a documented, data-backed route risk assessment. The 2016 MHRA deficiency data cited assessments with 'erroneous assumptions concerning UK climatic conditions'. Couriers should be chosen from an approved, risk-assessed list, not on price.
Can we send fridge lines in an insulated box instead of a refrigerated van?Interpretation
The MHRA blog says validated insulated containers can be used for small volumes of lower-risk products on journeys under three hours. Longer journeys need gel or ice packs, positioned so they never touch the product. Larger volumes, or journeys likely to be long or delayed, generally need refrigerated transport. Whatever the method, you must be able to show the required temperatures are maintained.
What's agreed, and what isn't
The three-hour figure is the blog author's practical guide, not an EU GDP limit. The blog calls routine temperature monitoring of all refrigerated deliveries best practice, especially for high-risk products such as vaccines, insulin and blood products, which are vulnerable to freezing as well as heat.
Do we need to keep and review the temperature data from each delivery?Interpretation
The MHRA blog says best practice is calibrated temperature monitoring that gives data for the entire journey. The wholesaler should keep this data for the required five years. Distributors should review the data for each consignment and have procedures for corrective action when something goes wrong. Each journey should be treated as unique, with length, complexity and season considered when choosing packaging and transport.
What's agreed, and what isn't
Monitoring every shipment is described as best practice, not an absolute requirement. The 2020 MHRA transport blog adds that where shipments are not individually monitored, "a very robust validation is required with clearly defined limits of validation".
Does a depot or freight site that holds our medicines overnight need to be on a wholesale licence?Interpretation
MHRA policy, set out in the inspector's blog, is that a site does not need to be named on a licence if ambient products are held there for less than 36 hours in transit and ownership has not transferred. Sites holding ambient products for more than 36 hours must be licensed. Sites holding refrigerated products must be licensed even for less than 36 hours, unless the products stay overnight in continuously refrigerated vehicles.
What's agreed, and what isn't
The policy only covers storage in transit; if picking, handling returns or decisions on resale happen there, the site must be on the licence. During COVID-19 the MHRA temporarily allowed up to 96 hours at a transit hub without a WDA(H), with a risk assessment. That was a temporary flexibility, not a change to this policy.
How do we know a cold pack is properly conditioned before packing a shipment?Interpretation
The MHRA freezer blog says checking whether a pack feels solid is 'a false test of conditioning'. Packs freeze from the outside, and over-frozen (supercooled) packs can freeze products below their range. Use packs only as the manufacturer's instructions or your own qualification define, use the right phase-change temperature for the product, and be able to trace how long each pack has been conditioned. Prevent mix-ups between conditioned and unconditioned packs, for example by numbering them or rotating freezers.
What's agreed, and what isn't
The blog notes some packs are fully conditioned in a soft gel state, so rules differ by product. Domestic freezers can take more than 24 hours to condition packs, so they may not suit a high-throughput pack-out.
How do we prove veterinary medicines stay in range in practice vehicles and courier deliveries?Interpretation
VMD expects vehicle cold storage to be researched, tested and validated before use. Records should show when the unit reached temperature, when medicines went in, and that they were removed before any excursion. Where vehicle ambient temperatures may exceed 25°C, use validated insulated containers or active cooling. For deliveries, including by courier, send validated test parcels through the real service at least twice a year, ideally in very cold and very warm weather, on the highest-risk routes identified by risk assessment. The test should show how long the packaging holds and that deliveries arrive within that time.
What's agreed, and what isn't
A thermometer left in a packed parcel in a room does not count as a valid test. Delivery to parcel collection boxes must be included in the validation, and the VMD suggests that in some cases the safest option is not to use it. Responsibility stays with the supplying premises even when a courier gives assurances.
If the customer collects the goods (ex-works), are we still responsible for transport temperature?Interpretation
Yes, according to the MHRA. The 2020 transport QRM blog says that although ex-works may suit the commercial terms, GDP makes the supplier responsible for delivering the medicine to the customer's delivery address. Using ex-works to step away from transport control is described as an abdication of responsibility that 'is not acceptable', and in one example it raised the supplier's inspection risk rating.
What's agreed, and what isn't
The 2016 MHRA deficiency data also cited 'customer collects' arrangements where GDP responsibilities had not been formalised. The practical answer is a written agreement defining who controls and monitors the journey, with the supplier keeping oversight.
What transport temperature failings did MHRA inspectors cite in their deficiency data?Interpretation
The MHRA 2016 GDP deficiency data gives these transport examples. There was no sound assessment of whether ambient products needed temperature control across all transport routes, including third-party distributors. Uncontrolled ambient transport was used with no risk assessment. Transport temperature was monitored with uncalibrated equipment. Risk assessments contained erroneous assumptions about UK climate. Companies could not show ambient products stayed within limits for the whole journey. 'Customer collects' arrangements had not been formalised.
What's agreed, and what isn't
These were major deficiencies. They confirm that ambient products are in scope for transport temperature control, a point small wholesalers often miss.
What does the HTA expect if the mortuary loses power or runs out of fridge space?Guidance
PFE2(i) requires documented contingency plans for power failure or shortage of refrigerated space, and says bodies should not be stored unrefrigerated or more than one to a tray. HTA contingency guidance adds that all temporary storage facilities need temperature monitoring and regularly tested alarm and call-out systems. Hiring temporary units or using funeral directors should not be the only contingency arrangement. The HTA expects an escalating, tested set of arrangements, mutual aid with neighbours, and capacity shortages recorded on the risk register.
Brexit happened. Which version of the EU GMP Guide applies to a manufacturer in Great Britain?Law
Regulation C17 of the Human Medicines Regulations 2012 lets the MHRA publish its own GMP and GDP guidelines. Until it does, C17(3) says the guidelines published or adopted by the European Commission "as they applied immediately before IP completion day" (31 December 2020) continue to apply. The MHRA's 2020 note on EU guidance says Great Britain uses the versions as they stood at that date, while Northern Ireland uses the current EU versions.
What's agreed, and what isn't
Since 1 January 2025 C17 covers the whole UK (amended by the Windsor Framework regulations, SI 2024/832), and no later gov.uk page restates the GB and Northern Ireland split for GMP guidelines. In practice the MHRA still points manufacturers to EudraLex Volume 4 and the Orange Guide, which Pharmaceutical Press updated in 2026 for the revised Annex 19. Texts adopted after 2020, such as the 2022 Annex 1, are a point to confirm with your inspector if you rely on a GB-only reading.
Do the blood storage rules apply to a hospital blood bank, or only to blood establishments?Law
They apply to hospital blood banks too. Regulation 9 requires the person managing a hospital blood bank to keep a quality system that gives effect to the EDQM Good Practice Guidelines (reg 9(1)(b)), make sure storage, transport and distribution conditions meet Part 4 of the Schedule, and validate all Part 4 processes that apply to its activities. Documentation must be available for inspection, traceability data must be kept for at least 30 years, and serious adverse event records for at least 15 years.
What's agreed, and what isn't
Regulation 9 does not itself specify how storage must be monitored (continuous, alarms, mapping); that detail comes in through the EDQM Good Practice Guidelines the quality system must give effect to. MHRA inspectors apply those, GMP-style expectations and the Red Book in practice. The 30-year requirement covers traceability data, not necessarily raw temperature logs, so a local retention decision is needed for those. For blood bank refrigerator and freezer temperature charts, the RCPath and IBMS retention guidance (6th edition, October 2025, section 6.1.5) says 15 years; that is professional guidance, not law. The retention table on the records and data integrity page compares the periods.
Is following GDP actually a legal requirement for a UK wholesaler, or just best practice?Law
It is a legal condition of the licence. Regulation 43 of the Human Medicines Regulations 2012 requires a licence holder to comply with the GDP guidelines and to provide and maintain staff, premises, equipment and facilities for handling, storage and distribution as are necessary to maintain the quality of the products. It also requires a quality system setting out responsibilities, processes and risk management measures.
What's agreed, and what isn't
For Great Britain, the guidelines are those published under, or applying by virtue of, regulation C17; in practice this means the EU GDP Guidelines 2013/C 343/01 as they stood at the end of the Brexit transition period, unless the MHRA replaces them. Northern Ireland licence holders follow the European Commission guidelines directly. The regulation sets the duty; the detail of temperature control sits in the GDP guidelines, not the statute.
Is following GMP a legal requirement for a UK manufacturer, or guidance we can choose to follow?Law
It is a legal condition of the licence. Regulation 37(2) of the Human Medicines Regulations 2012 requires a manufacturer's licence holder to comply with the principles and guidelines of good manufacturing practice, and 37(6) requires the staff, premises and equipment necessary for the stages of manufacture and assembly. Regulation 38(3)(a) applies the same duty to importers.
What's agreed, and what isn't
The regulation sets the duty; the detail on storage, monitoring, calibration and qualification sits in the EU GMP Guide (EudraLex Volume 4), which the MHRA applies. The MHRA's licensing page says that to qualify for a manufacturer's licence you must show you comply with EU GMP and pass regular GMP inspections.
What makes GMP a legal requirement for a manufacturer in Ireland?Law
The Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539/2007), regulation 10(1), says a manufacturing authorisation holder must not manufacture medicinal products except in line with Schedule 2 and the principles and guidelines of GMP in the GMP Directive (Commission Directive 2003/94/EC). Schedule 2 requires premises, installations and equipment for handling, storage and distribution necessary to maintain product quality.
What's agreed, and what isn't
This is the regulation as made; later amendments implementing the EU's replacement GMP directive were not checked here. The HPRA inspects against the EU GMP Guide and grades deficiencies as critical, major or other, as the MHRA does.
Do we need a written temperature control policy, and what should it cover?Guidance
SPS says every organisation that stores or transports medicines should have a local temperature control policy, tailored to how many fridges, freezers and ambient areas it has and how critical the medicines are. The policy should cover responsibility and accountability for storage, choosing storage areas, setting up new fridges and freezers including the set point, monitoring and recording, routine maintenance, temperature during transport, handling excursions, and "contingency plans in the event of breakdown of temperature controls".
What's agreed, and what isn't
SPS does not name roles. It identifies the regulators as the GPhC for registered pharmacies, the CQC for hospitals, GP practices and care homes, and the MHRA for specials and wholesale licence holders.
Does changing our insulated shipper or heating settings need formal change control in Ireland?Guidance
Yes, the HPRA GDP guide gives a change of insulated shipper for cold-chain products, a change to heating system settings and relocation of a storage area as examples of changes needing change control. Changes should be evaluated for impact on quality and traceability, including validation, and approved by relevant managers and the RP before implementation.
What's agreed, and what isn't
Such changes can also be mapping or qualification triggers under IA-G0011. The guide notes wholesalers working to other accredited standards should do a gap analysis against GDP.
Does the community pharmacy flu and COVID-19 vaccination service specify fridge requirements?Guidance
The 2026/27 NHS England advanced service specification requires the contractor to have SOPs for the service, including procedures to ensure cold chain integrity, with escalation, record-keeping and staff training covered. Vaccination must be done with appropriate cold chain management, including appropriate and timely action when temperatures deviate. Staff must follow the SOPs, which should be reviewed regularly and after any significant incident.
What's agreed, and what isn't
The specification does not set reading frequencies or equipment standards. It relies on the Green Book and on the pharmacy's own SOPs, so the detail sits in UKHSA guidance and GPhC inspection expectations.
How does the HPRA grade GDP inspection findings, and where do temperature failures fit?Guidance
The HPRA uses Critical, Major and Other. Critical means a significant risk to patients or public health (example: activity increasing the risk of falsified medicines reaching patients). Major means a deviation resulting, or likely to result, in a product not complying with its authorisations, and HPRA names failure to comply with required storage and transport conditions as an example; combinations of related lower findings can be escalated.
What's agreed, and what isn't
The current HPRA inspections page gives no temperature example at Critical level. However, the HPRA's GDP Information Day slides (3 May 2022) listed 'storage of products requiring refrigeration at ambient temperatures' as an example of a possible Critical deficiency, the same example as MHRA Guidance Note 6. In practice a severe temperature failure could be graded Critical by either regulator.
How much effort should go into the risk assessment behind our monitoring, mapping and calibration decisions?Guidance
ICH Q9(R1) says the effort, formality and documentation of quality risk management should be commensurate with the level of risk, and risk evaluation should be based on scientific knowledge and link to protecting the patient. Formality is not binary, and "resource constraints should not be used to justify the use of lower levels of formality". Its Annex II gives uses that fit monitoring directly: setting calibration and maintenance schedules, the extent of qualification, and the adequacy of storage and transport conditions.
What's agreed, and what isn't
Q9(R1) also asks for subjectivity to be managed and for decisions to rest on relevant data, so a requalification interval backed by trend data from continuous monitoring is easier to defend than one chosen by habit.
How often does the HPRA inspect wholesalers and what is published afterwards?Guidance
The HPRA wholesaling guide says routine inspections take place at least once every three years, more often for large wholesalers or those with poor compliance, and new wholesalers may be inspected about 12 to 18 months after the authorisation is granted. Inspection reports are sent within 15 days; routine and application inspections result in a GDP certificate or a 'statement of non-compliance with GDP', both published to EudraGMDP. The HPRA may refuse, suspend or revoke a WDA under S.I. No. 538 of 2007.
What's agreed, and what isn't
Published frequencies vary between HPRA documents: the GDP inspections web page says the first routine follow-up usually takes place 18 to 24 months after the initial (application) inspection, a different starting point from IA-G0008, and later ones are risk-based, and the general sale guide cites a six-month to five-year cycle. HPRA annual reports record 130 GDP inspections at wholesalers and distributors in 2024 and 128 in 2025. We found no HPRA publication of inspection reports; the HPRA's inspection material describes reports being issued to the company only.
How often does the Responsible Person have to review temperature records under HPRA guidance?Guidance
IA-G0011 repeatedly states that temperature records should be checked daily and independently reviewed (and, for ambient storage, approved) on a monthly basis by the Responsible Person, with a record of the review kept. Deviations outside limits should be notified promptly to the RP and investigations documented.
What's agreed, and what isn't
Where alarms notify staff audibly in real time and out of hours, the guide allows the frequency of checking monitoring records to be extended if the rationale is documented and justified. The EU GDP Guidelines do not specify a monthly RP review; this is HPRA-specific detail.
If our home care agency looks after a client's medicines, are we responsible for fridge storage?Guidance
NICE NG67 says responsibility for storing medicines usually stays with the person and their family or carers. Where a social care provider has agreed to take it on, recommendation 1.10.4 asks for sound processes, including seeking health professional advice on safe storage if needed, identifying the need for fridge storage, assessing the need for secure storage and reviewing storage needs. Recommendation 1.10.1 asks for a risk assessment of transport arrangements where the provider is involved.
What's agreed, and what isn't
NG67 sets no temperature monitoring requirement for people's homes. The 2015 NHS Pharmaceutical QA Committee guidance also excludes patients' own homes from its scope.
If we outsource mapping, calibration or monitoring, who is responsible when it goes wrong?Guidance
You are. ICH Q10, 2.7 says the pharmaceutical company is ultimately responsible for processes that assure control of outsourced activities, with a written agreement between contract giver and acceptor. Management review should include feedback on outsourced activities (4.1), and deviations go through CAPA with effort proportionate to risk (3.2.2).
What's agreed, and what isn't
MHRA's 2015 GMP deficiency examples include mapping by a contractor that the company had not approved. Approve the protocol before the study, review and approve the report, and audit the supplier. For a monitoring platform, Annex 11 asks for formal agreements with suppliers and service providers (clause 3).
We make or store investigational medicinal products. Which GMP rules apply in Great Britain and Northern Ireland?Guidance
Since the amended UK clinical trials regulations took effect on 28 April 2026, the MHRA says GMP for IMPs means the principles in Commission Directive 2003/94/EC for Great Britain and Commission Delegated Regulation 2017/1569 for Northern Ireland. The MHRA says separate GB guidelines for IMPs, intended to reflect the 2010 EU Annex 13, will be published in their own document.
What's agreed, and what isn't
Until that GB guide appears, the 2010 Annex 13 is the reference for GB: it asks the QP to verify conditions of storage and shipment (40) and for storage records at the original site to be reviewed before a transfer between trial sites (47). The MHRA page cites "Directive (EU) 2017/1559", which appears to be a typo.
What does NICE say care homes must have in place for medicines storage temperatures?Guidance
NICE SC1 recommendation 1.12.2 says a care home's process for storing medicines safely should include how and where medicines are stored, including fridge medicines and skin creams. It should also cover secure storage accessible only to authorised staff, and "the temperatures for storing medicines and how the storage conditions should be monitored". Recommendation 1.12.3 asks providers to assess each resident's storage needs.
What's agreed, and what isn't
NICE does not give temperature ranges, a check frequency, a fridge type or a retention period. It leaves these to the provider's process. Answers to 'do we need a dedicated medicines fridge?' or 'how often should we check the room?' therefore come from SPS, RPS, CQC or local ICB guidance, not NICE.
What experience does the HPRA expect of a Responsible Person, and can the RP be contracted?Guidance
The HPRA GDP guide treats evidence of six months' full-time direct GDP experience as a minimum, plus knowledge of the WDA conditions, the products and their storage needs, and the relevant law. A contract RP is allowed but needs a contract, must fulfil all RP duties under EU GDP 2.2, and time on site should be based on a documented risk assessment, with a record of time spent in the role.
What's agreed, and what isn't
Suitability is assessed case by case at application and on inspection, and part-time RPs must show they are contactable and present enough. This six-month minimum is HPRA-specific; the MHRA's comparable guidance sets one year's practical experience, so multi-country RPs should check each authority's text.
What is the Orange Guide, and is it different from the EU GMP Guide?Guidance
The Orange Guide is the MHRA's compilation "Rules and Guidance for Pharmaceutical Manufacturers and Distributors", published by Pharmaceutical Press. Its publisher describes it as the single source of European and UK guidance and UK legislation on the manufacture and distribution of medicines, including the EU GMP Guide as applied in the UK, the Qualified Person code of practice and guidance on investigational medicines. The Green Guide is the separate book for distributors (GDP).
What's agreed, and what isn't
It reproduces the EU GMP texts rather than replacing them, so the clauses you cite (for example Chapter 3, 3.19) are the same. The MHRA's GMP page lists the 2022 Orange and Green Guides; the Orange Guide is now sold as an online subscription and was updated in 2026 for Annex 19. The 2017 edition added an MHRA section on temperature control and monitoring.
What temperature-control knowledge and availability does the MHRA expect from a wholesale RP?Guidance
MHRA Guidance Note 6 says the RP must have at least one year's practical experience of the licensed activities. They must have the technical knowledge to understand storage conditions and temperature control and how to transport medicines. The RP should be continuously contactable, resident in the UK, and should personally know the conditions needed for safe storage and distribution of the products traded. RP duties include approving returns to saleable stock and deciding the final disposition of returned or rejected products.
What's agreed, and what isn't
GN6 says the term 'Deputy RP' is not legally recognised; only the named RP carries legal responsibility, including for delegated tasks such as daily temperature checks. The RP must receive written reports on delegated duties and keep records showing oversight.
Who in a GP practice is responsible for the vaccine fridge?Guidance
The SW ICARS toolkit, following Green Book chapter 3, says at least two people should be nominated, one from nursing and one from administration or management. They are responsible for ordering, receiving and looking after vaccines and for maintaining the cold chain. It also recommends a quarterly vaccine management review, at least weekly stock rotation checks, and orders every two to four weeks to avoid stockpiling.
What's agreed, and what isn't
The toolkit's list of avoidable breaches includes unclear roles and missed checks during staff absence. Naming deputies and setting up cross-cover is part of the expectation, not an optional extra.
Who should be responsible for checking ward temperatures and acting on out-of-range readings?Guidance
The 2015 NHS Pharmaceutical QA Committee document says there should be "clear lines of responsibility" for checking temperatures, recording results, reporting out-of-limit results, investigating them, and ensuring the affected medicines are assessed before anyone decides to keep using them. Its template fridge record has a space for who out-of-limit results should be reported to. It says out-of-limit results should always be reported to the appropriate person in the clinical area.
What's agreed, and what isn't
No national source in this set names a specific role, such as nurse in charge or ward pharmacist. SPS and RPS both leave it to local policy. The archived SPS 2020 COVID-19 vaccine fridge guide said checks could be delegated, but responsibility stayed with the clinical supervisor, who should review the log at least weekly.
Do the GPhC standards for registered pharmacies set a fridge temperature requirement?Interpretation
Not explicitly. Standard 4.3 says medicines and medical devices must be obtained from a reputable source, safe and fit for purpose, stored securely, safeguarded from unauthorised access, supplied safely and disposed of safely. There is no temperature wording. In practice, GPhC inspectors assess cold chain under 4.3. For example, a 2026 published improvement action plan recorded 4.3 as not met because a pharmacy recorded temperatures for only one of its two medicines fridges, and the unrecorded fridge showed an out-of-range maximum. The fixes included calibrated thermometers, daily recording for both fridges, and noting the reasons for anomalies.
What's agreed, and what isn't
The expectation of daily records and action on out-of-range readings comes from inspection practice and SPS/RPS guidance, not from the text of the standard. An individual action plan shows one inspector's finding and is not a GPhC policy statement.
How often do MHRA GMP inspectors actually cite storage temperature and calibration?Interpretation
In MHRA's published 2019 GMP deficiency data, covering 258 inspections and 1,648 deficiencies, Chapter 3, 3.19 (storage conditions provided, checked and monitored) was cited in 38 inspections and 3.41 (calibration) in 41. Annex 11 (computerised systems) was cited in 95 inspections and Annex 15 (qualification and validation) in 117. In the 2018 data (286 inspections) the figures were 49 for 3.19, 49 for 3.41, 87 for Annex 11 and 154 for Annex 15.
What's agreed, and what isn't
These are our counts from MHRA's spreadsheets, which record each EU GMP clause cited; one inspection can cite a clause more than once. Most 3.19 and 3.41 citations were graded Other, with some Majors and no Criticals. MHRA has published no GMP deficiency data after 2019. The 2019 summary ranks 3.41 eighth and 3.19 ninth among the most cited clauses in 2017.
What cold chain evidence will a CQC inspector ask a GP practice for?Interpretation
Inspectors expect evidence that the cold chain is maintained from receipt of vaccines to administration, following the national (PHE, now UKHSA) recommendations. They may ask for the fridge temperature log, maintenance checks and a policy on what to do if a temperature breach occurs, and may look in the fridge. CQC says the cold chain policy should cover handling from delivery to administration, transport of vaccines outside the practice, actions after a breach and how learning from incidents is shared. At least two trained, designated staff should be responsible for ordering, receiving and caring for vaccines.
What's agreed, and what isn't
The mythbuster still names Public Health England, whose functions passed to UKHSA; the Green Book chapter 3 and the UKHSA protocol remain the reference documents.
What temperature monitoring problems do MHRA GMP inspectors actually find at manufacturers?Interpretation
MHRA's 2016 GMP deficiency examples include: alarm limits wider than the product storage range; temperature and humidity captured only as twice-daily spot readings with no max/min data; no acceptance criteria for external calibration of warehouse probes; a receiving area not monitored against its limit; API shipped without temperature monitoring or control; and a standards fridge checked only weekly with no max/min readout. Import findings included no justification for not having a logger in every air-freight pallet, and procedures allowing mean kinetic temperature to assess excursions without investigating the cause.
What's agreed, and what isn't
These are examples from one year's dosage-form inspections, published to support self-inspection, not new requirements. More recent MHRA GMP deficiency datasets are summary-level and do not give comparable temperature examples.
What temperature-related problems do MHRA GDP inspectors most often find?Interpretation
In the MHRA's published 2016 GDP deficiency data, a sample of 148 of 1,428 inspections, major findings under premises and equipment included the following. Mapping was not adequate to show the areas were suitable or to place thermometers at the extremes. Cold chain deviations were recorded but not put through CAPA. A warehouse thermometer had not been calibrated across its operating range. An ambient thermometer was installed so readings did not come from the calibrated probe. A fridge had ice build-up, read 0.6°C, and had unrecorded changes to its control dial.
What's agreed, and what isn't
This is the only GDP-specific deficiency report found on GOV.UK. The 2018 and 2019 deficiency files published on GOV.UK are GMP data, and later GDP data were not found. Patterns may have changed since 2016. The MHRA warns against focusing only on these deficiencies at the expense of risks specific to your business.
20-minute compliance check
Would your records answer these questions?
In 20 minutes we go through how you prove temperature control to your inspector: monitoring, alarms, mapping, calibration and excursions. You get the gaps in writing. No product tour.