UKAS accredited calibration laboratory No. 10723

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Guidance library · 47 questions

Temperature control on hospital wards and in pharmacy

Ward fridges, treatment rooms that run warm, weekend checks and who acts on an alarm: the guidance for hospitals and hospital pharmacy.

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Reviewed by Jake Farrow, Managing DirectorLast reviewed 19 October 2026

Ward and clinic medicines should sit in pharmacy-specification fridges and monitored rooms, with a reading at least daily, alerts that reach a person when nobody is nearby, and a stepwise process when a reading goes out of range. Most of the working detail comes from NHS SPS and the 2015 NHS Pharmaceutical QA Committee guidance, with RPS setting the professional principle. The one thing to remember: every out-of-range result needs a named person to act on it and a record of what they decided.

Why it matters

Busy clinical areas, quiet weekends, and displays that can be wrong

Ward medicines are stored in clinical areas that can run warm in hot weather and are not always staffed. The 2015 NHS Pharmaceutical QA Committee document says areas staffed for only part of the week may need more control and monitoring than areas that are always occupied (NHS Pharmaceutical QA Committee, 2015).

Equipment can mislead as well. An RPS case study describes a vaccine fridge whose built-in display read normally while an independent thermometer showed 0 °C. The display was faulty and all the vaccines were destroyed. Afterwards every fridge was given a second, external thermometer. That is the case for monitoring that is independent of the fridge's own control, the first requirement of the recorder standard EN 12830.

What the rules say

Professional guidance, NHS technical guidance and local policy

The RPS professional guidance says fridges must be designed for medicines and monitored 'on each working day using a calibrated maximum-minimum thermometer', that storage outside the manufacturer's range needs a full risk assessment, and that there must be a policy for excursions. It sets the principle but not the method.

The method comes from SPS and the 2015 QA Committee document. The 2015 document gives a model pharmacy-specification fridge (no freezer box or door shelves, fan circulation, a lock) and asks for 'clear lines of responsibility' for checking, recording, reporting and investigating. SPS covers excursions, alerts and sensors. Neither names a role such as nurse in charge; that is for trust policy.

Some areas have their own rules. SPS notes that departments holding a wholesale dealer's licence must still meet those requirements in full, and reads an MHRA licence as needing 3-point calibration; the MHRA and EU GDP texts are risk-based and set no number of points, while the HPRA asks for three. Blood fridges follow the Red Book, which keeps red cells out of 2 °C to 6 °C storage for under 30 minutes where possible. It also allows up to 60 minutes out, with the unit then quarantined for 6 hours or more, no more than three times, and transfusion should finish within 4 hours (7.3.2.6). For what the product probe should sit in, see blood product simulants: water, glycerol or a validated block.

What good looks like

Every day: read, record, reset, and let the alert do the night shift

The 2015 document asks for min/max readings at least daily in every medicines storage area, with a reset after each reading and the thermometer in the worst-case position found by mapping or risk assessment. SPS says room storage would ideally sit between 15 °C and 25 °C (SPS on ambient storage).

Because audible alarms can be missed, SPS calls networked alerts by SMS, email or phone "the most robust means of alerting users" out of hours. It suggests a fridge alert just inside the limit, such as 7.5 °C, a delay 'as short a period as practically possible', and an alarm that re-sounds after a set period if still out of range.

Every year, and when things change

SPS says sensors should be calibrated annually to ±0.5 °C by an accredited service, with certificates kept. Its mapping guidance describes 8 to 25 loggers in an ambient room, at least 48 hours of data, initial ambient mapping in summer and winter, and fridges mapped full. It makes re-mapping risk-based rather than fixed.

Worked example

Monday 08:15: the alert log shows a Saturday excursion

This is an illustrative example. The nurse in charge opens the ward fridge record on Monday and finds a maximum of 10.4 °C since Friday. The networked alert log shows the fridge rose above 8 °C at 14:20 on Saturday and came back into range three hours later; the alert reached the site team, who found the door had not latched after a delivery.

Because the log gives the duration, the assessment can be specific. The stock is labelled 'DO NOT USE', the pharmacy assesses each product against its SmPC or the SPS stability tool, and the outcome is recorded with batch numbers. SPS lists three outcomes: usable with a shortened expiry, usable with extra patient monitoring, or discarded. Who may authorise a shortened expiry is set by local policy.

The SPS excursion process
  1. Fix the obvious causeDoor, power, sensor position. Keep the door shut.
  2. QuarantineLabel the stock 'DO NOT USE' until it has been assessed.
  3. Record the excursionMaximum, minimum and total time out of range.
  4. Assess each productSmPC, SPS stability tool or manufacturer's medical information.
  5. Decide and labelUsable, usable with a shorter expiry, or discard and reorder.
  6. Report and preventIncident procedure, batch numbers, actions to stop a repeat.

From SPS, Managing temperature excursions (2024). Vaccines also follow UKHSA vaccine incident guidance.

Where it is unclear

Where the sources differ

RPS asks for a reading each working day, which leaves weekends to local risk assessment (weekends and closed periods). The 2015 document quarantines ambient stock earlier than current SPS advice in hot weather (room temperature in heatwaves), and mean kinetic temperature is treated differently in clinical areas and wholesale (MKT). SPS and UKHSA use 20 minutes as the point below which a one-off fridge rise is unlikely to matter (NHS clinical guidance that does not apply to WDA or MIA holders, for whom every excursion is a deviation), but other regulators define excursions differently (any duration, 5 or 20 minutes), and probe placement advice varies (centre or mapped extremes).

In summary

The short version

  • Store cold chain medicines in pharmacy-specification fridges, not domestic or laboratory units.
  • Read, record and reset min/max thermometers at least daily in every storage area.
  • Use networked alerts that reach a named person out of hours, and log every alert.
  • Write down who checks, who is told and who decides about stock after an excursion.
  • Follow the SPS excursion process: quarantine, record, assess, decide, report.
  • Calibrate sensors yearly and map rooms and fridges, re-mapping on risk and change.
  • Blood fridges and licensed pharmacy areas follow their own additional rules.

Hospitals and wards

Questions, answered from the source

Last checked 19 October 2026. Each answer links to its source and says whether it is law, formal guidance or interpretation.

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."

Status
Formal guidance
Applies to
Care homes, GP practices, Hospitals and wards, Dental, Community pharmacy
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories, Community pharmacy
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Blood, Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Care homes, GP practices, Hospitals and wards, Community pharmacy
Last checked
18 October 2026
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.

Source
Storing medicines at ambient temperatures NHS SPS, 24 June 2026
Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Care homes, Community pharmacy
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards, Care homes, GP practices
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Blood, Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Hospitals and wards, Care homes
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Community pharmacy, Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Blood, Hospitals and wards
Last checked
18 October 2026
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.

Source
Managing temperature excursions NHS SPS, 9 July 2024
Status
Formal guidance
Applies to
Hospitals and wards, Community pharmacy, GP practices
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Blood, Hospitals and wards
Last checked
18 October 2026
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.

Source
Managing temperature excursions NHS SPS, 9 July 2024
Status
Formal guidance
Applies to
Hospitals and wards, Community pharmacy, GP practices
Last checked
18 October 2026
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.

Source
Managing temperature excursions NHS SPS, 9 July 2024
Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Care homes, Community pharmacy
Last checked
18 October 2026
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.

Source
Managing temperature excursions NHS SPS, 9 July 2024
Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Care homes, Community pharmacy
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Care homes, Transport
Last checked
18 October 2026
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.

Status
Interpretation
Applies to
Wholesalers (WDA), Community pharmacy, Hospitals and wards
Last checked
18 October 2026
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.

Status
Interpretation
Applies to
Wholesalers (WDA), Community pharmacy, Hospitals and wards
Last checked
18 October 2026
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.

Status
Interpretation
Applies to
Hospitals and wards, GP practices
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards, Community pharmacy, GP practices, Care homes
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories, Blood
Last checked
19 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards, Care homes, GP practices, Community pharmacy
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Manufacturers, Laboratories
Last checked
19 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Care homes, Dental
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Blood, Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories, Community pharmacy
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards, GP practices, Community pharmacy, Care homes
Last checked
18 October 2026
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.

Status
Interpretation
Applies to
GP practices, Hospitals and wards, Community pharmacy
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories, Transport
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards, Laboratories, Wholesalers (WDA), GP practices, Community pharmacy
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories, Transport
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers, Hospitals and wards, Laboratories, Blood, Tissue and mortuary
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Transport, Hospitals and wards, GP practices, Community pharmacy
Last checked
18 October 2026
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.

Status
Law
Applies to
Blood, Hospitals and wards
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
Hospitals and wards
Last checked
18 October 2026

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