Guidance library · 72 questions

Vaccine and medicines storage in GP 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.

Reviewed by Jake Farrow, Managing DirectorLast reviewed 19 October 2026

A GP practice is expected to follow Green Book chapter 3 for its vaccine fridges, and CQC will ask to see that it does. What makes a practice different is that it is usually closed at weekends, it takes vaccines out to clinics and home visits, and it is the provider that decides what happens after a breach. The full cold chain teaching, with a worked excursion, is on Vaccine fridges.

Why it matters

The practice owns the decision and the consequences

When a vaccine fridge fails, UKHSA's incident guidance says the provider where the breach happened decides, case by case, after advice from the screening and immunisation team, the health protection team and the manufacturer. If the vaccines are used, the prescriber or provider takes responsibility, so the reasoning must be well documented.

Closed periods are where practices are most exposed. The Green Book asks for readings each working day and says nothing about weekends, so a reading on Monday morning has to cover the whole weekend through the max/min memory. A fridge that failed on Friday evening may not be noticed until Monday, and the max/min reading cannot say when it started. SPS's excursion guidance says to assume the worst case from the last reset, which over a weekend can mean treating stock as out of range for about 72 hours.

What the rules say

Green Book, CQC and your contract

The national reference is Green Book chapter 3. For practices it adds one specific duty: at least two named people, one from the nursing team and one from administration or management, responsible for ordering, receiving and caring for vaccines, including cold chain recording, stock rotation and disposal.

CQC's GP mythbuster 17 is CQC's reading of that guidance and shows what an inspector will ask for: the fridge temperature log, maintenance checks and a policy on what to do after a breach. 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.

Contracts can add their own wording. The NHS England GP COVID-19 vaccination enhanced service specification (2024–26, now expired) required max/min thermometers in every fridge storing vaccine and readings "on all working days". That version ran to March 2026, so check the one in force. In Northern Ireland, the PHA guidance for GP practices asks for a data logger as back-up and same-day reporting of significant breaches to HSC Trust Medicines Information and the PHA duty room.

What good looks like

A routine built around opening hours

The NHS England South West ICARS cold chain toolkit, regional guidance built on the Green Book, is the clearest description of a practice routine. It recommends fridge checks in the closing routine before weekends and bank holidays, and downloading data loggers weekly, ideally on first entering the premises after the weekend and before the first vaccines of the week are given. It also names unclear roles and missed checks during staff absence among avoidable breaches, so deputies and cross-cover are part of the expectation.

CQC is clear that a logger does not replace the daily manual check. Even with one fitted, you still read and record the minimum, maximum and current temperatures and reset each working day, and CQC warns that reviewing a logger only weekly or monthly risks missing breaches.

A practice cold chain routine
  1. Trained staffEvery working day
    • Read current, max and min
    • Record and sign
    • Reset the thermometer
    • React to anything outside +2 °C to +8 °C
  2. Trained staff, with coverAround closuresWeekends and bank holidays
    • Fridge check in the closing routine
    • Logger download on first entry, before the first vaccine
  3. Named vaccine leadsWeekly to quarterly
    • Weekly stock rotation and expiry check
    • Order every two to four weeks
    • Quarterly vaccine management review
  4. Named vaccine leadsEvery year
    • Fridge service
    • Thermometer calibration
    • Maintenance log kept with the fridge

Drawn from Green Book chapter 3, CQC GP mythbuster 17 and the NHS England SW ICARS toolkit.

Worked example

A flu clinic at a care home

This is an illustrative example. A nurse takes vaccines to a care home for a morning clinic. Following the Green Book and the SW ICARS toolkit, she uses a validated medical-grade cool box with a validated max/min thermometer, takes only enough vaccine for the session, keeps the vaccines in their original packaging and wrapped so they do not touch the cool packs, and records the cool box temperature at the start and end of the session.

Back at the practice, the end-of-session record shows the box stayed within +2 °C to +8 °C, so the unused vaccines can go back in the fridge, marked with the return date and time and used first. If the thermometer had not been read, there would be no evidence the cold chain held, and the stock would be risk assessed as for a fridge excursion.

Where it is unclear

Paper, loggers and weekends

Whether an alarmed, continuously monitored system could replace the daily paper record is not answered by CQC: see logger versus daily reading. Check with your ICB or inspector before dropping paper records. Reading frequency also varies by nation, from once each working day in England to twice daily recommended in Scotland: see once or twice a day. For weekends, no source sets a rule, so assess how long a failure could go unnoticed and how much stock you hold, and record your reasoning in your cold chain policy. Our recommendation below gives a default to start from.

In summary

The short version

  • Name at least two vaccine leads, one nursing and one administrative, and set up deputies for absence.
  • Read, record, reset and react every working day, even with a data logger fitted.
  • Add a fridge check to the closing routine before weekends and bank holidays.
  • Check the weekend before the first vaccine on Monday, using logger data where you have it.
  • Use validated cool boxes with a max/min thermometer for clinics, recorded at the start and end of each session.
  • After a breach, quarantine, report to the screening and immunisation team, and record who advised and who decided.

GP practices

Questions, answered from the source

Last checked 18 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
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.

Status
Formal guidance
Applies to
Care homes, Community pharmacy, GP practices
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
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.

Status
Interpretation
Applies to
GP practices
Last checked
18 October 2026
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.

Status
Interpretation
Applies to
GP practices
Last checked
18 October 2026
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.

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

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

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

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

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

Source
Keep your vaccines healthy poster and magnet UKHSA, 3 September 2026
Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
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.

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

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

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

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

Status
Formal guidance
Applies to
GP practices, Community pharmacy, Care homes
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
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.

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

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

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

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

Source
Guidance on vaccine storage and handling (Version 1) Public Health Scotland, March 2023
Status
Formal guidance
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
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.

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

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

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

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

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

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

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

Status
Formal guidance
Applies to
GP practices
Last checked
18 October 2026
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.

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

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

Source
Guidance on vaccine handling and storage in GP practices (V4) Public Health Agency (NI), August 2024
Status
Formal guidance
Applies to
GP practices
Last checked
18 October 2026
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.

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

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

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

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

Status
Formal guidance
Applies to
GP practices, Community pharmacy
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
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.

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

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

Status
Formal guidance
Applies to
GP practices
Last checked
18 October 2026
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.

Status
Interpretation
Applies to
GP practices
Last checked
18 October 2026
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.

Source
Vaccine update: issue 369, February 2026 UKHSA, 11 March 2026
Status
Interpretation
Applies to
GP practices, Community pharmacy
Last checked
18 October 2026
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.

Source
Vaccine update: issue 374, August 2026 UKHSA, 28 August 2026
Status
Interpretation
Applies to
GP practices, Community pharmacy
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 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
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
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
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.

Source
Guidance on vaccine handling and storage in GP practices Public Health Agency (NI), 30 September 2024
Status
Formal guidance
Applies to
GP practices
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
GP practices
Last checked
18 October 2026
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.

Status
Formal guidance
Applies to
GP practices
Last checked
18 October 2026
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.

Source
Guidance on vaccine handling and storage in GP practices Public Health Agency (NI), 30 September 2024
Status
Formal guidance
Applies to
GP practices
Last checked
18 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 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.

Status
Formal guidance
Applies to
GP practices, 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
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.

Status
Interpretation
Applies to
GP practices
Last checked
18 October 2026
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.

Status
Interpretation
Applies to
GP practices
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
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
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.

Status
Formal guidance
Applies to
GP practices, Transport
Last checked
18 October 2026
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.

Source
Guidance on vaccine handling and storage in GP practices Public Health Agency (NI), 30 September 2024
Status
Formal guidance
Applies to
GP practices, Transport
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
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.

Status
Formal guidance
Applies to
GP practices
Last checked
18 October 2026
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.

Status
Interpretation
Applies to
GP practices
Last checked
18 October 2026

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