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GDP temperature control for wholesalers

What WDA holders and Responsible Persons must show: mapped stores, calibrated monitoring, alarms, qualified transport and records, from the MHRA and the GDP guidelines.

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Reviewed by Jake Farrow, Managing DirectorLast reviewed 19 October 2026

If you hold a wholesale dealer's authorisation, the MHRA expects you to store and transport medicines within their labelled conditions and to prove it, and the Responsible Person answers for that proof. This page walks the chain from the RP's desk: storage, monitoring, mapping, transport, returns and outsourcing. The one thing to remember: GDP sets outcomes and leaves most numbers to you, so every interval and limit needs a written, risk-based reason.

Why it matters

Temperature is a licence condition

A wholesaler sits between the manufacturer and every pharmacy, hospital and practice it supplies, so a failure in your store or your van travels downstream to patients who cannot see it. The regulator grades it accordingly: MHRA Guidance Note 6 gives storage of refrigerated products at ambient temperature as a possible Critical finding, and defines a Major as a deficiency that may cause non-compliance with the marketing authorisation, in particular its storage and transport conditions.

Nothing is out of scope because its label is silent. The EMA's GDP Q&A says leaving products with no labelled storage condition unmonitored is not acceptable, because their stability data assume defined climate conditions.

What the rules say

Law, guidelines, then the Inspectorate's view

Regulation 43 of the Human Medicines Regulations 2012 makes compliance with the GDP guidelines a legal condition of the licence, and requires the staff, premises, equipment and quality system needed to maintain product quality. For Great Britain the guidelines are in practice the EU GDP Guidelines 2013/C 343/01 as retained; Northern Ireland follows the Commission's text directly. The MHRA GDP Inspectorate inspects and enforces.

The guidelines set outcomes. The MHRA's detailed interpretation is mostly in Inspectorate blog posts on refrigerated storage, mapping, transport and returns and transport risk. Blogs are not law, but they show what inspectors look for. If you also trade in Ireland, the HPRA publishes formal numbered guides; see MHRA and HPRA compared. If you also hold a manufacturer's licence, see GMP storage, mapping and monitoring.

What Guidance Note 6 asks of the RP

Guidance Note 6 says the RP needs at least one year's practical experience of the licensed activities and the technical knowledge to understand storage conditions, temperature control and transport. They should be continuously contactable, resident in the UK, approve returns to saleable stock and decide the final disposition of returned or rejected products. 'Deputy RP' is not a legally recognised term: you can delegate daily temperature checks, but the named RP keeps the responsibility, receives written reports and keeps records showing oversight.

The mapping blog adds that the RP should be involved in the whole mapping process, supervise routine monitoring and be consulted on any excursion. For applicants, Guidance Note 6 expects mapping with a clear methodology and evidence of transport validation before the first inspection.

What good looks like

Storage and monitoring the inspector will recognise

For fridge lines the 2016 blog expects a pharmaceutical refrigerator: fan-circulated, monitored by a calibrated electronic min/max thermometer accurate to ±0.5 °C that can be read without opening the door, with no ice box. Walk-in cold rooms need an electronic recording device measuring load temperature in one or more places, and alarms for power loss as well as temperature. The freezer blog says most frozen medicines need −15 °C to −20 °C and ice boxes are 'not supported in any circumstance'. In every case, keep the monitoring probe independent of the unit's control probe, as the HPRA and the recorder standard EN 12830 both ask.

EU GDP 3.3 asks for alarms set appropriately and regularly tested, and calibration at risk-based intervals, traceable to a national standard. Section 3.3.1 asks for computerised monitoring to be validated before use, with backups kept at least five years at a separate, secure location, and the MHRA's data integrity guidance does not accept a supplier's validation pack in isolation from your own configuration. Detail is on monitoring and alarms, mapping, justifying probe positions and records.

An RP's routine, from the sources

No single source gives a calendar, so this one is assembled from several. Where a frequency is a minimum from one source rather than a UK rule, it says so.

  • Every day: read or review the monitoring for every area, record any deviation and the action taken, and tell the RP (MHRA 2016 blog). WHO goes further with twice-daily checks, seven days a week.
  • Every consignment: check incoming cold chain deliveries and review the temperature data for outgoing ones (MHRA 2016 blogs).
  • Routinely: the RP reviews and signs off the records (MHRA); the HPRA asks for a monthly review in Ireland.
  • Every six months: test alarms at their set points, if you follow WHO's minimum; EU GDP gives no interval.
  • Every year: calibrate transport monitoring equipment (EU GDP 9.2, at least annually) and service fridges (MHRA blog, at least annually).
  • At self-inspection: review the mapping risk assessment and re-mapping interval (MHRA mapping blog).

In SematicsScheduled intraday check reports, repeating at whatever interval you set, with minimum, maximum and average for every asset, every alarm and its actions, and time within limits. Set them to your checking frequency.How it works

Transport, returns and outsourcing

Your responsibility runs to the customer's door, and the 2020 blog says ex-works terms do not change that. Every route needs a risk assessment, qualified vehicles or packaging, and monitoring or a validation sound enough to stand in for it; the transport page covers this in full.

Returns are where control is easiest to lose. EU GDP 6.3 allows a fridge line back into stock only with documented evidence that it stayed in its authorised conditions throughout: delivery, examination, opening and repacking, collection and return to your fridge. Chapter 7 makes you responsible for anything you outsource, with a written contract, an audit before work starts and no subcontracting without your approval, and section 3.2 says contracted storage premises should hold their own authorisation. We recommend the written agreement also requires the contractor to report any excursion to you within one working day of the event, with the data (our recommendation; GDP sets no deadline).

Worked example

An RP's Monday morning

This is an illustrative example; the site, times and readings are invented.

08:15. The RP reviews the weekend alarm log. Cold room 2 alarmed at 02:40 on Sunday and reached 8.9 °C for 35 minutes before the on-call operative closed a door left ajar. What they do: check the stock positions against the mapping, quarantine the affected batches, ask the marketing authorisation holder for stability data, and decide disposition on that evidence. What they record: the deviation, the root cause, the MAH reply, the decision and a CAPA for door alarms.

10:00. A customer without a wholesale authorisation asks to return a fridge line delivered on Friday. It has no record of how the stock was kept since delivery, and the return falls outside the MHRA's 24-hour window, so the RP declines, as EU GDP 6.3 requires evidence of storage throughout.

11:30. A proof of delivery shows the courier used a subcontractor nobody approved. Chapter 7 requires your prior evaluation, so the RP raises it with the courier and books an audit.

Where it is unclear

Where the numbers disagree

Much of the detail a wholesaler needs is either unstated or contested. Returns windows run from the MHRA's 24 hours for refrigerated returns in GB to EU GDP's 'for example 10 days', which is not the UK expectation (returns). RP experience is one year for the MHRA and six months for the HPRA (RP experience). Transit storage is 36 hours for the MHRA and 48 for the HPRA (storage in transit).

Intervals are left to you: re-mapping, alarm testing and calibration have no single UK figure. And the MHRA discourages mean kinetic temperature in wholesale "without robust supporting information and methodology".

Inspection findings

What the 2016 deficiency data show

The MHRA GDP Inspection Deficiency Data 2016, explained on the Inspectorate blog, sampled 148 of 1,428 inspections and counted major findings only. The quality system drew a Major in 22% of sampled inspections, transportation in 13%, the RP in 12%, and temperature control under section 3.2.1 in 9%.

The temperature examples are specific. Mapping did not show the areas were suitable or where thermometers should go; cold chain deviations were recorded but never put through CAPA; a warehouse thermometer was not calibrated across its operating range; a fridge had ice build-up, read 0.6 °C and had unrecorded changes to its dial; and an RP admitted adding fabricated readings to fill gaps. Transport findings included uncontrolled ambient delivery with no risk assessment, uncalibrated transport monitoring and 'customer collects' arrangements never formalised. The report itself recommends not using these deficiencies "as a point of focus at the expense of risks that may be higher for their particular organisation".

This is the only GDP-specific dataset found on GOV.UK. The 2023 symposium reported 1,189 deficiencies across 473 inspections without a published breakdown.

Share of sampled GDP inspections with a Major finding, 2016
Quality system (1.2)22%
Transportation (9.2)13%
Responsible Person (2.2)12%
Temperature control (3.2.1)9%

MHRA GDP Inspection Deficiency Data 2016: 148 of 1,428 inspections sampled, Majors only. Four of the areas reported.

In summary

The short version

  • Treat GDP as a licence condition: regulation 43 makes it law, the guidelines set the detail.
  • Make sure the named RP can show oversight of every delegated temperature check.
  • Map, monitor, alarm and calibrate every storage area, and validate the monitoring system for your use.
  • Control every route to the customer's door, including couriers and ex-works collections.
  • Accept cold chain returns only with evidence of storage throughout.
  • Put CAPA behind every deviation, and never back-fill a missed reading.
  • Where the sources differ, assess the risk and record your reasoning.

Wholesalers (WDA)

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.

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
Can a wholesaler use a domestic fridge, or one just labelled 'medical', for fridge lines?Interpretation

The MHRA inspector's blog says a pharmaceutical refrigerator is required for refrigerated medicinal products. It describes these as fan-circulated for a uniform temperature and fast pull-down after door opening, monitored by a calibrated electronic min/max thermometer accurate to ±0.5°C that can be read without opening the door. Quoting the Green Guide, it warns that a fridge 'purported to be medical or pharmaceutical' is not automatically suitable. It should have no internal ice box and no internal dials that can be knocked.

What's agreed, and what isn't

The blog is aimed at wholesale (GDP) storage; other settings such as GP practices and pharmacies follow their own guidance (for example the Green Book and SPS), which is broadly similar. When buying, the blog suggests checking how long the unit holds temperature during a power cut and how it copes with hot spells.

Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Can we use a domestic freezer, or the ice box of a fridge, for frozen medicines or cold packs?Interpretation

The MHRA freezer blog says refrigerator ice boxes are 'not supported in any circumstance' for GDP use. It warns that domestic freezers may have auto-defrost cycles causing high excursions and are less able to hold a narrow range. Freezers storing medicines should be dedicated, or shown not to be affected by freezing cold packs. Most frozen medicines need -15°C to -20°C, and freezers must be qualified, monitored and mapped like refrigerators.

What's agreed, and what isn't

The blog does not ban domestic freezers outright; it lists their drawbacks and leaves the choice to qualification evidence. It also flags that combined fridge-freezers on one compressor can compromise both compartments. If you only stock a few frozen lines, it suggests not holding them or outsourcing.

Source
Use of Freezers MHRA, 20 June 2017
Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
If a medicine has no storage conditions on the label, do we still need to monitor its temperature?Interpretation

Yes. EMA's GDP Q&A says it is not acceptable to leave storage unmonitored. A product without a storage statement has been justified by stability data at 25°C/60% RH or 30°C/65% RH (long term) and 40°C/75% RH (accelerated), reflecting climate zones I and II. Controls should therefore keep conditions relevant to those zones, temperature should be monitored during storage and transport, and appropriate monitoring limits should be set.

What's agreed, and what isn't

The Q&A does not give a specific numerical limit; you have to set and justify one. It applies to EU GDP, which MHRA applies in the UK through its GDP guidance, but check MHRA's own position for UK-specific nuance.

Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Is it a problem if our pharmacy fridge is packed full, or we chill gel packs in it?Interpretation

Quoting the Green Guide, the MHRA blog says enough space should be kept for air circulation, products should not touch the walls or floor, and if a fridge is filled to capacity, the effect on temperature distribution should be investigated. Where non-refrigerated items such as unconditioned gel packs go into the fridge, the temperature rise they cause should be assessed. Stock of different status (incoming, quarantine, returned, outgoing) should be segregated.

What's agreed, and what isn't

No fill limit is given; the expectation is evidence (for example mapping at full load) rather than a percentage rule. The 2017 freezer blog makes the same point for freezers, recommending dedicated units for medicines rather than shared use for conditioning cold packs.

Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Where should the temperature probe go in a fridge, and how should we stock it?Interpretation

The MHRA blog says calibrated probes should be placed centrally, preferably between products, and not in the door. Products should be stored in an orderly way on shelves, not on the floor, so air can circulate. The fridge should be cleaned regularly and serviced at least annually, any alarm tested routinely at specified temperatures, stock rotated first expiry first out, and no food or drink kept in it.

What's agreed, and what isn't

This placement advice is a general default. EU GDP and the MHRA mapping blog expect permanent probes to be placed where mapping shows the extremes, which may not be the centre. Where these conflict, follow your mapping data and document why.

Status
Interpretation
Applies to
Wholesalers (WDA)
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
Can a returned fridge line go back into saleable stock in Ireland?Guidance

HPRA policy is that cold-chain products may only be returned to saleable stock where there is no reasonable possibility the cold chain was compromised. Examples given are where the batch was recorded on distribution and the whole delivery-and-return process is validated, or where a unique monitoring device attached to the product shows whether it left refrigerated conditions.

What's agreed, and what isn't

This closely mirrors EU GDP section 6.3, which already requires documented evidence of authorised storage throughout and lists the same chain of steps (delivery, examination, re-packing, collection, return to the fridge); the HPRA adds the attached-monitor option. If any deviation occurred, EU GDP requires a risk assessment demonstrating product integrity. Returns criteria should be established in procedures.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Can we use mean kinetic temperature (MKT) to justify an ambient excursion in Ireland?Guidance

Only under strict conditions. IA-G0011 says MKT applies only to controlled room temperature products (e.g. 'Do not store above 25°C'), never to refrigerated products, cannot compensate for poor premises control, and storage temperatures should not exceed 30°C at any point if MKT is used. The MA holder should be consulted on whether MKT is applicable, and excursions outside labelled conditions should still be documented, investigated and reported to the MA holder.

What's agreed, and what isn't

Use of MKT should be described in a written procedure and the number of excursions above label limits kept limited. Whether MKT is acceptable for a given product depends on the product's stability data, so the MAH's view is decisive.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
For a general sale (GSL) wholesaler in Ireland, how should a temperature deviation be classified in our own deviation system?Guidance

The HPRA's model quality system for general sale wholesalers gives 'temperature deviations' as an example of a Major deviation (potential to compromise product quality) in the company's own classification scheme, alongside a Critical tier (e.g. failure to quarantine unsuitable product) and a Minor tier. Its temperature SOP template requires initial mapping or a documented RP-approved risk assessment, worst-case probe placement and daily max/min recording.

What's agreed, and what isn't

This is a company-level deviation classification example, not the HPRA's inspection grading. The guide says inspection frequency for these distributors is risk-based, between six months and five years.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What does GDP say we must do when a temperature excursion happens in transit?Guidance

EU GDP 9.2 says a deviation such as a temperature excursion during transport should be reported to the distributor and to the recipient of the affected products, and a procedure should be in place for investigating and handling excursions. Risk assessment of delivery routes should decide where temperature controls are needed.

What's agreed, and what isn't

The guideline does not define how long an excursion has to last before it counts, or who decides whether the product can be used. In practice the RP decides disposition, using stability information from the manufacturer or marketing authorisation holder. MHRA inspectors have warned that such data is often not directly comparable to the excursion.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
What does the HPRA say we must do after a temperature excursion?Guidance

The HPRA defines an excursion as a deviation from labelled storage conditions 'for any duration of time' in storage or transport. Excursions should be notified immediately to the RP, affected product quarantined until the investigation outcome is known, the manufacturer/MAH consulted on quality impact, the investigation and outcome documented, and corrective actions implemented. If a recall may be required, the HPRA should be notified immediately.

What's agreed, and what isn't

Excursions in fridges or freezers used only to condition ice packs should be investigated with equal thoroughness. The guide does not set a minimum duration below which an excursion can be ignored, which differs from informal commentary elsewhere about very short excursions.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers, 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
Can we use mean kinetic temperature (MKT) to show an excursion didn't matter?Interpretation

Generally no. Quoting the Green Guide, the MHRA blog says MKT is only appropriate where the marketing authorisation holder gives an acceptable MKT value for the specific product and the temperature record is complete from leaving the manufacturer. In practice MKT fails where there is no complete temperature record for the consignment. Use of MKT in wholesale "without robust supporting information and methodology is therefore discouraged".

What's agreed, and what isn't

The 2020 MHRA transport blog repeats the concern, describing attempts to apply MKT to underestimate the impact of excursions. MKT may still appear in manufacturer stability justifications; the point is that a wholesaler cannot use it on its own to excuse poor control.

Status
Interpretation
Applies to
Wholesalers (WDA)
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
Is it acceptable to accept a load after an excursion if the stock is probably fine?Interpretation

The MHRA transport QRM blog says it is 'rare to find sound scientific justification' for accepting a load after an excursion. It notes that manufacturer stability information is often not directly comparable to the excursion. It says the most common reason for acceptance is commercial, which may put patients at risk and undermines risk management. The acceptable range is the product's labelled storage conditions.

What's agreed, and what isn't

This is inspector commentary, not a ban; release after an excursion remains possible with product-specific evidence from the marketing authorisation holder and an RP decision. The blog also says risk assessment 'should not be used' to justify an unsuitable practice (see also the 2020 COVID GDP blog).

Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Do refrigerated vans have to be temperature mapped?Guidance

Yes, if temperature-controlled vehicles are used. EU GDP 9.4 says temperature mapping under representative conditions should be carried out and should take account of seasonal variations, and the monitoring equipment should be maintained and calibrated. For temperature-sensitive products, qualified equipment (thermal packaging, temperature-controlled containers or vehicles) should be used between manufacturer, wholesaler and customer.

What's agreed, and what isn't

No method, duration or re-mapping interval is specified. 'Seasonal variations' is generally read as summer and winter mapping, but the guideline does not say so. Customers can ask for evidence that products stayed within their temperature conditions, and you should be able to provide it.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Do we have to temperature map a storage area before we start putting medicines in it?Guidance

Yes. EU GDP 3.2.1 says an initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. The permanent monitoring devices should then be placed according to the mapping results, in the areas that experience the extremes of fluctuation. Mapping should be repeated according to a risk assessment or whenever significant modifications are made to the facility or the temperature-controlling equipment.

What's agreed, and what isn't

The guideline does not say how to map, how many sensors to use, how long to run it, or a fixed re-mapping interval; these are left to the company's risk assessment. 'Representative conditions' is not defined, which is why MHRA inspectors have also expected loaded and seasonal mapping (see the MHRA mapping blog).

Status
Formal guidance
Applies to
Wholesalers (WDA)
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
In Ireland, does the HPRA expect an ambient warehouse to be mapped in both summer and winter, and empty and full?Guidance

Yes. The HPRA temperature guide (IA-G0011) says warehouses should be mapped in the empty and full states and that mapping should be performed during both summer and winter to assess worst-case conditions. Mapping should be repeated after significant modification to the premises, changes in stock layout or changes to the heating system, and areas such as skylights and controlled drug cabinets should be included.

What's agreed, and what isn't

The guide does not set a fixed re-mapping interval (e.g. every X years); re-mapping is trigger-based. It also flags turning heating off overnight or at weekends as something to consider. The EU GDP Guidelines themselves only say mapping should be done 'under representative conditions'; the explicit summer/winter and empty/full wording is HPRA elaboration.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers
Last checked
18 October 2026
Our Irish storage area is tiny. Do we need a full temperature mapping study?Guidance

The HPRA GDP guide says an initial mapping exercise must be performed and documented for areas greater than a few square metres; for room-temperature areas smaller than that, a risk assessment can be used instead. Continuous monitoring probes should then be placed according to the mapping or risk assessment in all storage areas, including pick-face, quarantine and returns, with at least a max/min thermometer read and reset daily.

What's agreed, and what isn't

This mirrors EU GDP 3.2.1, which has the same 'few square meters' concession; the HPRA wording makes mapping a 'must' above that size. 'A few square metres' is not defined numerically. The concession applies to room-temperature areas only; IA-G0011 still expects mapping to inform probe locations in small fridges. Products with no labelled storage condition may be stored at temperatures not exceeding 30°C according to the same guide.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Our store is just a small room at room temperature - do we need a full mapping study?Guidance

EU GDP 3.2.1 makes a specific allowance: for small premises of a few square metres at room temperature, an assessment of potential risks (for example heaters) should be conducted and temperature monitors placed accordingly. This is offered instead of the formal mapping exercise described for larger storage areas.

What's agreed, and what isn't

'A few square metres' is not defined. The MHRA's 2016 mapping blog, aimed at small storage areas and small fridges, still describes a mapping exercise with calibrated probes, so many inspectors will expect some recorded data, not only a desk-based risk assessment. The allowance covers room-temperature premises only, not fridges or cold rooms. Check with your inspector if in doubt.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
We're applying for a new WDA(H) - do we need mapping done before the inspection?Guidance

Yes. MHRA Guidance Note 6 says applicants must be inspection-ready at the point of application. That includes being able to show a temperature mapping exercise of the proposed wholesale area with a clear methodology, and evidence of transport validation. Applicants should also give details of ambient and cold chain storage, transport arrangements, computerised systems and business contingency plans.

What's agreed, and what isn't

GN6 does not define what counts as adequate transport validation. For small applicants using couriers, this usually means courier qualification plus packaging or lane qualification evidence. The MHRA mapping blog notes that new applicants are often unclear about mapping expectations.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
When does the HPRA expect a walk-in cold room or large fridge to be re-mapped?Guidance

IA-G0011 says large refrigerators and walk-in cold rooms should be mapped on installation in the empty and full states, with an ambient probe outside the unit. Re-mapping is expected after significant changes such as repair or replacement of the refrigeration unit, changes to internal layout, changes to set points, and changes to how duty/back-up condensers are run, including swapping which is main and which is back-up; if units are routinely rotated, both should be in the mapping study. Moving a small fridge may also require re-mapping.

What's agreed, and what isn't

These are specific triggers that go further in detail than the EU GDP text. The guide's wording varies in strength: re-mapping after a change to how duty/back-up condensers are run 'is required', while moving a fridge 'may' require it, and most other triggers use 'should'. None of it is a legal requirement. No fixed periodic re-mapping frequency is given.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers
Last checked
18 October 2026
When we qualify a cold room or freezer, which alarm tests should be in the OQ?Guidance

WHO Supplement 7 says OQ is normally done empty and includes alarm tests: at least one high and one low alarm test, plus door-open alarms, and every notification route (sounder, strobe, remote or SaaS service, SMS or phone) needs to be tested. OQ also covers empty mapping for at least 24 hours, door-opening recovery and a power-failure holdover test.

What's agreed, and what isn't

WHO writes for storage and distribution, but the supplement covers ultra-low freezers, freezers, cold rooms and controlled ambient stores, and its steps match the Annex 15 OQ. Do not start PQ until OQ deviations are closed (2.6).

Status
Formal guidance
Applies to
Manufacturers, Laboratories, Wholesalers (WDA)
Last checked
19 October 2026
How often should we re-map, and what is the RP's role?Interpretation

The MHRA blog says the risk assessment from mapping should define and justify how often future mapping is done, and should be reviewed regularly, for example during self-inspection. Mapping should be repeated for seasonal variation and if the storage area is reconfigured. The RP should be involved in the whole mapping process, aware of the findings and recommendations, supervise routine daily min/max monitoring, and be consulted on any temperature excursion.

What's agreed, and what isn't

No fixed re-mapping interval is set by EU GDP or this blog. Annual or summer/winter mapping is a common industry convention, not an MHRA rule. Be ready to justify whatever interval you choose.

Source
Temperature mapping - an introduction MHRA, 14 July 2016
Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
How should a small wholesaler actually carry out a temperature mapping exercise?Interpretation

The MHRA mapping blog says to map before stock is stored if possible, using dummy product in empty fridges, freezers and cold stores, and to repeat the mapping when fully stocked and to cover seasonal variation. Cover the highest point of storage and problem areas such as heaters, lighting, windows, doors, loading bays and mezzanines. Include CD rooms, packing, returns and quarantine areas. Use enough calibrated probes for the size of the area, then risk-assess the data to place permanent probes at hot and cold spots.

What's agreed, and what isn't

The blog notes that EU GDP requires mapping but 'does not state how this should be done'. It gives no probe numbers, grid spacing or duration. Larger sites often use specialist third parties. The blog does not answer how long each mapping run should last.

Source
Temperature mapping - an introduction MHRA, 14 July 2016
Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What does 'initial temperature mapping' actually involve, and does it have to cover summer and winter?Interpretation

The Commission's Q&A describes initial mapping as placing sensors at the points a risk analysis shows to be most critical (for example different heights, near a sunny window, next to doors), measuring over a period, and then putting the monitoring sensors where the greatest fluctuation occurred. It says mapping should be done in different seasons, when the highest and lowest temperatures are reached.

What's agreed, and what isn't

WHO Technical Supplement 8 agrees on two-season mapping for areas affected by seasonal variation, but says it is "typically" not necessary for cold rooms and freezer rooms. The Commission Q&A does not make that exception. For ambient warehouses, plan for both seasons. For refrigerated rooms, justify your choice.

Status
Interpretation
Applies to
Wholesalers (WDA)
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
Do we need temperature alarms, and do they have to be tested?Guidance

Yes. EU GDP 3.3 says appropriate alarm systems should be in place to alert when there are excursions from pre-defined storage conditions. Alarm levels should be set appropriately and alarms regularly tested to make sure they work.

What's agreed, and what isn't

The guideline does not define test frequency, alarm delay, or out-of-hours response. The MHRA's 2020 transport blog gave an example where poorly set alarms failed to trigger, giving false assurance that stock was in range. Alarm set points, delays and call-out arrangements should be justified in your own procedures.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 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 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 the HPRA expect from temperature alarms?Guidance

Where possible, monitoring systems should have alarms that immediately notify relevant personnel. Alarm set points may include alert and action limits (alert limits set so preventive action can be taken before an excursion), and provision should be made for an out-of-hours response. Alarms should be checked regularly at their set points without exposing product to out-of-specification temperatures, with records kept, and alarm nominees trained.

What's agreed, and what isn't

Probes may be placed in a load simulator to avoid nuisance alarms from door openings. For cold rooms, section 3.3 says 'Alarms should be fitted to the unit'. The freezer section (3.4) expects alarms on large and walk-in units and smaller units holding at-risk product; for small fridges an alarm is 'if fitted'. The guide gives no specific test frequency.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers
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
How many temperature probes do we need in our storage area?Interpretation

The European Commission's GDP Q&A says the number of probes and where they go depend on a risk analysis of the site, and placement should agree with the mapping results. It gives no fixed number.

What's agreed, and what isn't

WHO gives more concrete starting points. For walk-in spaces the number of monitoring points depends on size and on variations seen during mapping. For a refrigerator or freezer at least one monitoring point is needed, and WHO notes some regulators want two (warmest and coldest points). The Q&A states it is not legally binding.

Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
How often should we read the fridge thermometer, and what do we do if it's out of range?Interpretation

The MHRA blog says refrigerated stock should be monitored daily with a calibrated min/max device that has a calibration certificate. Records should show any deviation and the corrective action taken. As best practice, take a further reading later the same day to show the deviation was transient and the temperature is back in range. The RP should be informed of any deviation and should routinely review and sign off the records.

What's agreed, and what isn't

'Daily' is the minimum the blog describes; continuous electronic monitoring is now common and EU GDP expects alarms. The blog also expects records to be free from alterations and a trained deputy to cover absences. The blog does not say how to judge whether stock is still usable; that needs RP assessment and manufacturer stability data.

Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What monitoring does a walk-in cold room need compared with a small fridge?Interpretation

Quoting the Green Guide, the MHRA blog says large commercial fridges and walk-in cold rooms should be monitored by an electronic temperature recording device that measures load temperature in one or more places, depending on size. Alarms should be fitted for power outages as well as temperature excursions. Condensate from chillers should not collect inside, and as much maintenance as possible should be done from outside the unit.

What's agreed, and what isn't

The number of sensors is not specified; it should follow mapping results. The 2016 MHRA deficiency data cited a walk-in fridge with dirt build-up around the fans and no cleaning schedule, so cleaning records are part of compliance.

Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What temperatures should we set our alarms at?Interpretation

The Commission's Q&A says alarm settings should be chosen to guarantee a timely alert to staff when conditions move outside the predefined storage conditions. It does not give specific values.

What's agreed, and what isn't

WHO Supplement 6 suggests configuring both pre-alarms (triggered before the temperature goes out of range) and alarms after it goes out of range, with only authorised users able to set limits. MHRA's 2016 GMP deficiency data shows what goes wrong: alarms were set at 18 to 26°C for materials needing 2 to 25°C, so excursions between 25 and 26°C would not be flagged. Any alarm delay used to avoid nuisance alarms from door openings should be justified.

Status
Interpretation
Applies to
Wholesalers (WDA), All settings
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
How often do we need to calibrate the thermometers and loggers in our warehouse?Guidance

EU GDP 3.3 does not set a fixed interval: equipment used to control or monitor the storage environment should be calibrated at defined intervals based on a risk and reliability assessment. Calibration should be traceable to a national or international measurement standard. Repair, maintenance and calibration should be done in a way that does not compromise product integrity, and records should be kept.

What's agreed, and what isn't

Storage calibration is risk-based, but transport monitoring equipment has a stated minimum of at least once a year (EU GDP 9.2). Many companies use annual calibration for storage too for consistency. The 2016 MHRA deficiency data cited a warehouse thermometer that had not been calibrated across its operating range, so the calibration range matters as well as the date.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
How often must temperature loggers used in vans and shipping boxes be calibrated?Guidance

EU GDP 9.2 says equipment used to monitor temperature during transport in vehicles or containers should be maintained and calibrated at regular intervals, at least once a year. Section 9.4 repeats that monitoring equipment in temperature-controlled vehicles should be maintained and calibrated at regular intervals.

What's agreed, and what isn't

This is one of the few fixed frequencies in EU GDP; storage monitoring calibration is risk-based instead. Single-use loggers are usually covered by the supplier's calibration certificate, which should be checked as part of supplier qualification.

Status
Formal guidance
Applies to
Wholesalers (WDA), 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
What calibration does the HPRA expect for temperature monitoring probes?Guidance

Probes should be calibrated at least annually against a traceable reference, at a minimum of three points across the range of use (examples given: 0, 15 and 30°C for ambient warehouse probes; -10, 0 and 10°C for fridge probes). Calibration should cover the entire monitoring system (probes, receiver, display), certificates should state the method and be reviewed and approved by the wholesaler, and a failed calibration should trigger a review of previous readings.

What's agreed, and what isn't

Auxiliary calibrated probes should be used so storage areas stay monitored during calibration; serial numbers and certificates of these should be kept. Recording probes should have an accuracy of at least +/-0.5°C and be independent of control probes. In IA-G0011 section 3.3 the ±0.5 °C figure applies to large-volume cold storage only; the HPRA's 2022 mapping slides (slide 9) repeat it generally.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers
Last checked
18 October 2026
Can our QA lead or the person who reviews the data also be the administrator of the monitoring system?Guidance

The MHRA's GxP data integrity guidance says shared logins or generic user access should not be used for systems generating, amending or storing GxP data, and that system administrator rights "should not be assigned to individuals with a direct interest in the data (data generation, data review or approval)" (6.16). Audit trails identified as required should be switched on and users should not be able to amend or switch them off (6.13).

What's agreed, and what isn't

Administrator access should be kept to the fewest people possible for the size of the organisation, each with unique credentials so their actions show in the audit trail. In a cloud system the supplier usually holds platform administration; your own administrator roles still need the same separation.

Status
Formal guidance
Applies to
Manufacturers, Laboratories, Wholesalers (WDA)
Last checked
19 October 2026
Does an electronic temperature monitoring system need validating under HPRA GDP guidance?Guidance

The HPRA GDP guide says a computerised system relating to GDP processes should be shown, through validation or verification, to achieve results accurately, consistently and reproducibly before use, with the level of validation set by risk (complexity, bespoke vs off-the-shelf, customisation). It points to EU GMP Annex 11 for further information, and equipment qualification protocols should be approved by the RP.

What's agreed, and what isn't

The guide does not single out temperature monitoring systems or give data integrity (ALCOA+) detail; no HPRA GDP-specific data integrity guide was found. IA-G0011 adds that records must be retrievable, allow excursions to be identified, and that reviews must be recorded.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Does our electronic temperature monitoring system need to be validated, and how long do we keep the data?Guidance

EU GDP 3.3.1 says a computerised system should be shown, through validation or verification, to achieve the desired results accurately, consistently and reproducibly before it is used. Data should be protected against accidental or unauthorised change, checked periodically for accessibility, and backed up regularly. Backups should be kept for the period in national legislation but at least five years, at a separate and secure location.

What's agreed, and what isn't

The guideline also expects a written description of the system and defined procedures for system failure, including data restoration. It does not prescribe audit trail features; the MHRA GxP data integrity guidance gives more detail. Cloud-hosted systems still need the separate, secure backup location to be demonstrable.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
How long do we have to keep temperature records?Guidance

EU GDP chapter 4 says documents should be kept for the period stated in national legislation but at least five years, and records should be made at the time each operation is undertaken. Chapter 3.3.1 applies the same five-year minimum to backups of computerised system data.

What's agreed, and what isn't

Five years is a minimum; manufacturer, contract or other legal requirements may require longer. Records must be contemporaneous, so filling gaps afterwards is a data integrity failure (the 2016 MHRA deficiency data cites an RP who added fabricated readings).

Status
Formal guidance
Applies to
Wholesalers (WDA)
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 keep temperature records in a shared spreadsheet or report alarms over WhatsApp?Interpretation

The MHRA data integrity blog for GDP says multi-user spreadsheets can make it impossible to show who made an entry, when, or whether it was overwritten. It suggests restricting spreadsheets to non-critical data, or locking and version-controlling them. It says a wholesaler's proposal to use WhatsApp for quality-critical event reporting was refused because it could not meet data integrity requirements. It also gives an example where an inspector could not trust ambient min/max records because the thermometer was uncalibrated and staff did not know how to use it.

What's agreed, and what isn't

Computerised systems are encouraged if appropriately qualified and controlled. The MHRA GxP Data Integrity guidance (2018) gives the detailed ALCOA expectations. The MHRA's 2016 GDP deficiency data shows what happens otherwise: gaps in temperature records that an RP admitted filling with fabricated readings, entries in pencil, unsigned records and unapproved corrections, all cited as major deficiencies. Missed readings should be recorded as missed, never back-filled. The blog also says paper temperature records transcribed into an electronic system should be checked by a person of appropriate seniority.

Source
I don't believe it! MHRA, 25 May 2018
Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What data integrity failures in temperature records have MHRA GDP inspectors found at wholesalers?Interpretation

MHRA's 2016 GDP deficiency data includes a Responsible Person who admitted adding fabricated readings to fill gaps in temperature records. Other findings were records made in pencil, unsigned temperature records and unapproved corrections. Equipment findings included a warehouse thermometer not calibrated across its operating range, an ambient-area thermometer installed so readings were not taken from the calibrated probe, uncalibrated equipment used to monitor transport, and mapping that did not establish where to place thermometers.

What's agreed, and what isn't

The report is published to support self-inspection. It shows that inspectors treat gaps and fabricated or unattributed entries as serious. A missed reading should be recorded and explained as a gap, never filled in afterwards.

Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Can we qualify insulated cold-chain shippers in an environmental chamber for Irish distribution?Guidance

IA-G0011 states that qualification should use actual transport conditions and that chamber studies 'are not considered to be reflective of actual conditions'. Studies should send containers with loggers to the furthest delivery location, cover seasonal extremes (possibly separate summer and winter pack-outs), full and empty loads, and any door openings during delivery. The time of packing, not dispatch, should be recorded so receivers can confirm receipt within the validated time.

What's agreed, and what isn't

Ice-pack conditioning and re-freezing times should form part of validation, and freezers used for ice packs are subject to the same qualification as product freezers. The position on chamber studies is a notable HPRA-specific statement; it is not wording from the EU GDP Guidelines.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Does a haulier or courier holding medicines in transit in Ireland need a wholesale authorisation?Guidance

The HPRA's position is that storage of medicinal products for more than 48 hours during transportation, or any storage of refrigerated product regardless of time, is storage requiring that premises to hold a WDA. A carrier that does not own the product and only transports it generally does not need a WDA under the same conditions.

What's agreed, and what isn't

The wholesaling guide words the refrigerated case more softly ('may be regarded as falling within' WDA requirements), so for any cold-chain cross-dock arrangement it is worth confirming with the HPRA. Contracted transport should be audited and covered by a service level agreement that includes sub-contracting.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Does the HPRA require refrigerated vans to be temperature mapped?Guidance

Where refrigerated vehicles or containers are the primary means of environmental control, IA-G0011 says they should be validated and monitored, including mapping to find hot and cold spots under worst-case conditions (loaded to capacity, seasonal extremes) and considering door openings, power sources and breakdowns. Loads at risk of freezing should be monitored with calibrated data loggers, and single-use monitors should be qualified.

What's agreed, and what isn't

Vehicle validation is not necessary if a validated container/packaging configuration provides the primary environmental control. The guide gives no mapping frequency for vehicles.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
How do we qualify a refrigerated delivery van?Guidance

WHO Supplement 11 recommends a static mapping first to find hot and cold spots in the load space. This is followed by at least four tests: maximum and minimum payload in the warmest season, and maximum and minimum payload in the coldest season, ideally on a real worst-case route with multiple drops and door openings. The vehicle can be only provisionally qualified after the first season's tests, and fully qualified once both seasons are done, unless a test chamber is used to simulate them. An alternative is full qualification of each vehicle type plus an installation qualification for each new vehicle.

What's agreed, and what isn't

Requalification is expected after significant modifications and should be considered when monitoring shows unexplained variability. WHO sets no fixed interval.

Status
Formal guidance
Applies to
Transport, Wholesalers (WDA)
Last checked
18 October 2026
If we use a 3PL or courier, what do we need in place?Guidance

EU GDP chapter 7 requires a written contract that sets out each party's duties. The contract giver is responsible for the outsourced activity, must assess the contractor's competence, and should audit before work starts and whenever it changes, with audit frequency based on risk. The contractor must not subcontract without the contract giver's prior evaluation and approval. Chapter 9.2 adds that transport providers must be told the transport conditions for each consignment.

What's agreed, and what isn't

EU GDP 3.2 also says contracted premises should be covered by their own wholesale authorisation. The 2016 MHRA deficiency data included missing transport contracts, no audits of contract acceptors, and 3PLs allowed to subcontract without review.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Is it still allowed to use non-temperature-controlled transport when it's below 20°C outside?Guidance

This was a temporary COVID-19 flexibility. MHRA guidance from April 2020 allowed non-temperature-controlled transport when ambient temperature was below 20°C. It required 'do not refrigerate' products to be identified and shipped appropriately below 8°C, with a risk assessment and mitigation. The same guidance allowed storage equipment to be used with limited qualification, completed retrospectively, and products to be held at transit hubs for up to 96 hours without a WDA(H).

What's agreed, and what isn't

The GOV.UK page has not been formally withdrawn, but it was framed as temporary and under regular review, and the 2023 MHRA GDP symposium gave delegates an 'update on the Covid Flexibilities'. Do not rely on these flexibilities today without confirming with the GDP Inspectorate. Wholesalers using them also had to record the decision and notify Covid19.GMDP@mhra.gov.uk.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
What are the rules on using ice packs or cool packs in insulated boxes?Guidance

EU GDP 9.4 says cool packs must be placed so the product does not touch them directly. Staff must be trained to assemble insulated boxes, including seasonal configurations, and on reusing cool packs. There should be a system to control reuse so that incompletely cooled packs are not used by mistake, and frozen and chilled packs should be physically segregated. Delivery of sensitive products and control of seasonal temperature variation should be in a written procedure.

What's agreed, and what isn't

EU GDP 9.3 adds that container selection should consider external temperature extremes, maximum transit time including customs, and the qualification status of the packaging. Pack-out validation is expected but its method is not specified.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
What extra temperature controls does the MHRA expect when we ship medicines by air?Guidance

MHRA air freight guidance says aircraft hold temperature control is limited, and the 'greatest and most frequent vulnerability' is on the airport tarmac during loading and unloading. It recommends minimising tarmac time, priority ramp handling, covered storage at transit airports and thermal blankets. It also lists pre-conditioned temperature-controlled vehicles with electronic monitoring for ground legs, and cargo hold temperatures of +15°C to +25°C. The IATA Time and Temperature Sensitive label must show the external handling range, and that range must match the air waybill or service agreement.

What's agreed, and what isn't

The guidance was published as part of Brexit contingency planning (2019) and draws on WHO TRS 961 Supplements 12 and 13. Its technical content still reflects general expectations. Any variation from an airline's branded pharma service should be agreed beforehand in an SOP.

Source
Guidance on air freight of medicines MHRA, 9 October 2019
Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Are ordinary vans or curtain-sided trailers acceptable for ambient medicines?Interpretation

The MHRA transport QRM blog says dark solid-sided vans with no compartment cooling are more likely to get hot in summer. It says curtain-sided trailers are at high risk of both high and low temperature excursions, and of theft. It calls temperature-controlled vehicles the industry-chosen answer and expects interim risk mitigation while fleets are replaced. Other risk controls it mentions include delivering at cooler times of day in summer and outsourcing to couriers better able to control temperature.

What's agreed, and what isn't

Uncontrolled vehicles are not banned outright; the expectation is a documented, data-backed route risk assessment. The 2016 MHRA deficiency data cited assessments with 'erroneous assumptions concerning UK climatic conditions'. Couriers should be chosen from an approved, risk-assessed list, not on price.

Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Can we send fridge lines in an insulated box instead of a refrigerated van?Interpretation

The MHRA blog says validated insulated containers can be used for small volumes of lower-risk products on journeys under three hours. Longer journeys need gel or ice packs, positioned so they never touch the product. Larger volumes, or journeys likely to be long or delayed, generally need refrigerated transport. Whatever the method, you must be able to show the required temperatures are maintained.

What's agreed, and what isn't

The three-hour figure is the blog author's practical guide, not an EU GDP limit. The blog calls routine temperature monitoring of all refrigerated deliveries best practice, especially for high-risk products such as vaccines, insulin and blood products, which are vulnerable to freezing as well as heat.

Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Do we need to keep and review the temperature data from each delivery?Interpretation

The MHRA blog says best practice is calibrated temperature monitoring that gives data for the entire journey. The wholesaler should keep this data for the required five years. Distributors should review the data for each consignment and have procedures for corrective action when something goes wrong. Each journey should be treated as unique, with length, complexity and season considered when choosing packaging and transport.

What's agreed, and what isn't

Monitoring every shipment is described as best practice, not an absolute requirement. The 2020 MHRA transport blog adds that where shipments are not individually monitored, "a very robust validation is required with clearly defined limits of validation".

Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Does a depot or freight site that holds our medicines overnight need to be on a wholesale licence?Interpretation

MHRA policy, set out in the inspector's blog, is that a site does not need to be named on a licence if ambient products are held there for less than 36 hours in transit and ownership has not transferred. Sites holding ambient products for more than 36 hours must be licensed. Sites holding refrigerated products must be licensed even for less than 36 hours, unless the products stay overnight in continuously refrigerated vehicles.

What's agreed, and what isn't

The policy only covers storage in transit; if picking, handling returns or decisions on resale happen there, the site must be on the licence. During COVID-19 the MHRA temporarily allowed up to 96 hours at a transit hub without a WDA(H), with a risk assessment. That was a temporary flexibility, not a change to this policy.

Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
How do we know a cold pack is properly conditioned before packing a shipment?Interpretation

The MHRA freezer blog says checking whether a pack feels solid is 'a false test of conditioning'. Packs freeze from the outside, and over-frozen (supercooled) packs can freeze products below their range. Use packs only as the manufacturer's instructions or your own qualification define, use the right phase-change temperature for the product, and be able to trace how long each pack has been conditioned. Prevent mix-ups between conditioned and unconditioned packs, for example by numbering them or rotating freezers.

What's agreed, and what isn't

The blog notes some packs are fully conditioned in a soft gel state, so rules differ by product. Domestic freezers can take more than 24 hours to condition packs, so they may not suit a high-throughput pack-out.

Source
Use of Freezers MHRA, 20 June 2017
Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
If the customer collects the goods (ex-works), are we still responsible for transport temperature?Interpretation

Yes, according to the MHRA. The 2020 transport QRM blog says that although ex-works may suit the commercial terms, GDP makes the supplier responsible for delivering the medicine to the customer's delivery address. Using ex-works to step away from transport control is described as an abdication of responsibility that 'is not acceptable', and in one example it raised the supplier's inspection risk rating.

What's agreed, and what isn't

The 2016 MHRA deficiency data also cited 'customer collects' arrangements where GDP responsibilities had not been formalised. The practical answer is a written agreement defining who controls and monitors the journey, with the supplier keeping oversight.

Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
What transport temperature failings did MHRA inspectors cite in their deficiency data?Interpretation

The MHRA 2016 GDP deficiency data gives these transport examples. There was no sound assessment of whether ambient products needed temperature control across all transport routes, including third-party distributors. Uncontrolled ambient transport was used with no risk assessment. Transport temperature was monitored with uncalibrated equipment. Risk assessments contained erroneous assumptions about UK climate. Companies could not show ambient products stayed within limits for the whole journey. 'Customer collects' arrangements had not been formalised.

What's agreed, and what isn't

These were major deficiencies. They confirm that ambient products are in scope for transport temperature control, a point small wholesalers often miss.

Status
Interpretation
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Does changing our insulated shipper or heating settings need formal change control in Ireland?Guidance

Yes, the HPRA GDP guide gives a change of insulated shipper for cold-chain products, a change to heating system settings and relocation of a storage area as examples of changes needing change control. Changes should be evaluated for impact on quality and traceability, including validation, and approved by relevant managers and the RP before implementation.

What's agreed, and what isn't

Such changes can also be mapping or qualification triggers under IA-G0011. The guide notes wholesalers working to other accredited standards should do a gap analysis against GDP.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
How does the HPRA grade GDP inspection findings, and where do temperature failures fit?Guidance

The HPRA uses Critical, Major and Other. Critical means a significant risk to patients or public health (example: activity increasing the risk of falsified medicines reaching patients). Major means a deviation resulting, or likely to result, in a product not complying with its authorisations, and HPRA names failure to comply with required storage and transport conditions as an example; combinations of related lower findings can be escalated.

What's agreed, and what isn't

The current HPRA inspections page gives no temperature example at Critical level. However, the HPRA's GDP Information Day slides (3 May 2022) listed 'storage of products requiring refrigeration at ambient temperatures' as an example of a possible Critical deficiency, the same example as MHRA Guidance Note 6. In practice a severe temperature failure could be graded Critical by either regulator.

Source
GDP inspections HPRA, undated
Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
How much effort should go into the risk assessment behind our monitoring, mapping and calibration decisions?Guidance

ICH Q9(R1) says the effort, formality and documentation of quality risk management should be commensurate with the level of risk, and risk evaluation should be based on scientific knowledge and link to protecting the patient. Formality is not binary, and "resource constraints should not be used to justify the use of lower levels of formality". Its Annex II gives uses that fit monitoring directly: setting calibration and maintenance schedules, the extent of qualification, and the adequacy of storage and transport conditions.

What's agreed, and what isn't

Q9(R1) also asks for subjectivity to be managed and for decisions to rest on relevant data, so a requalification interval backed by trend data from continuous monitoring is easier to defend than one chosen by habit.

Status
Formal guidance
Applies to
Manufacturers, Laboratories, Wholesalers (WDA)
Last checked
19 October 2026
How often does the HPRA inspect wholesalers and what is published afterwards?Guidance

The HPRA wholesaling guide says routine inspections take place at least once every three years, more often for large wholesalers or those with poor compliance, and new wholesalers may be inspected about 12 to 18 months after the authorisation is granted. Inspection reports are sent within 15 days; routine and application inspections result in a GDP certificate or a 'statement of non-compliance with GDP', both published to EudraGMDP. The HPRA may refuse, suspend or revoke a WDA under S.I. No. 538 of 2007.

What's agreed, and what isn't

Published frequencies vary between HPRA documents: the GDP inspections web page says the first routine follow-up usually takes place 18 to 24 months after the initial (application) inspection, a different starting point from IA-G0008, and later ones are risk-based, and the general sale guide cites a six-month to five-year cycle. HPRA annual reports record 130 GDP inspections at wholesalers and distributors in 2024 and 128 in 2025. We found no HPRA publication of inspection reports; the HPRA's inspection material describes reports being issued to the company only.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
How often does the Responsible Person have to review temperature records under HPRA guidance?Guidance

IA-G0011 repeatedly states that temperature records should be checked daily and independently reviewed (and, for ambient storage, approved) on a monthly basis by the Responsible Person, with a record of the review kept. Deviations outside limits should be notified promptly to the RP and investigations documented.

What's agreed, and what isn't

Where alarms notify staff audibly in real time and out of hours, the guide allows the frequency of checking monitoring records to be extended if the rationale is documented and justified. The EU GDP Guidelines do not specify a monthly RP review; this is HPRA-specific detail.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What experience does the HPRA expect of a Responsible Person, and can the RP be contracted?Guidance

The HPRA GDP guide treats evidence of six months' full-time direct GDP experience as a minimum, plus knowledge of the WDA conditions, the products and their storage needs, and the relevant law. A contract RP is allowed but needs a contract, must fulfil all RP duties under EU GDP 2.2, and time on site should be based on a documented risk assessment, with a record of time spent in the role.

What's agreed, and what isn't

Suitability is assessed case by case at application and on inspection, and part-time RPs must show they are contactable and present enough. This six-month minimum is HPRA-specific; the MHRA's comparable guidance sets one year's practical experience, so multi-country RPs should check each authority's text.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What temperature-control knowledge and availability does the MHRA expect from a wholesale RP?Guidance

MHRA Guidance Note 6 says the RP must have at least one year's practical experience of the licensed activities. They must have the technical knowledge to understand storage conditions and temperature control and how to transport medicines. The RP should be continuously contactable, resident in the UK, and should personally know the conditions needed for safe storage and distribution of the products traded. RP duties include approving returns to saleable stock and deciding the final disposition of returned or rejected products.

What's agreed, and what isn't

GN6 says the term 'Deputy RP' is not legally recognised; only the named RP carries legal responsibility, including for delegated tasks such as daily temperature checks. The RP must receive written reports on delegated duties and keep records showing oversight.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What temperature-related problems do MHRA GDP inspectors most often find?Interpretation

In the MHRA's published 2016 GDP deficiency data, a sample of 148 of 1,428 inspections, major findings under premises and equipment included the following. Mapping was not adequate to show the areas were suitable or to place thermometers at the extremes. Cold chain deviations were recorded but not put through CAPA. A warehouse thermometer had not been calibrated across its operating range. An ambient thermometer was installed so readings did not come from the calibrated probe. A fridge had ice build-up, read 0.6°C, and had unrecorded changes to its control dial.

What's agreed, and what isn't

This is the only GDP-specific deficiency report found on GOV.UK. The 2018 and 2019 deficiency files published on GOV.UK are GMP data, and later GDP data were not found. Patterns may have changed since 2016. The MHRA warns against focusing only on these deficiencies at the expense of risks specific to your business.

Status
Interpretation
Applies to
Wholesalers (WDA)
Last checked
18 October 2026

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