UKAS accredited calibration laboratory No. 10723

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For WDA holders and Responsible Persons

What MHRA GDP requires of temperature

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. In practice that means mapping each storage area, placing calibrated monitoring at the extremes the mapping found, alarming and investigating every excursion, and keeping validated records for at least five years.

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Updated 18 October 2026Reviewed by Jake Farrow, Managing Director

At a glance

What it asks

GDP 3.2.1

Storage areas: map first, then monitor

What it says

Carry out an initial temperature mapping exercise on each storage area before use, under representative conditions. Place temperature monitoring equipment according to the results. Repeat the mapping after significant changes to the facility or the temperature-controlling equipment, or as your risk assessment sets. For small premises of a few square metres at room temperature, assess the potential risks (heaters, for example) and place the monitors to match.

What it means on site

A probe fitted by the door because that's where the cable reached is the most common gap. The monitoring must sit where your study found the hottest and coldest points, and the study must still describe the room as it is today: new racking, a new cooler or a moved door all count as changes.

How to evidence it

  • The mapping report and protocol for each storage area, with dates
  • A drawing or list linking each monitoring probe to a mapped extreme
  • Your risk assessment, and the trigger for re-mapping (seasonal or after changes)

GDP 3.3

Equipment: calibrated, alarmed and tested

What it says

Calibrate the equipment used to monitor storage conditions at defined intervals, based on a risk and reliability assessment, and make the calibration traceable to national or international standards. Have suitable alarm systems that alert you to excursions from pre-defined storage conditions. Set alarm levels appropriately and test the alarms regularly to make sure they work. Carry out repairs, maintenance and calibration so that the integrity of the medicines isn't compromised, and keep records.

What it means on site

Few sites can show the alarm test. An alarm that has never been triggered on purpose is an alarm nobody knows works. Calibration certificates also need to match the sensor in the unit today, not the one that was there last year.

How to evidence it

  • A calibration certificate for each monitoring sensor, in date, showing traceability
  • Alarm limits for each area and the reasoning behind them
  • A record of alarm tests: when, who, and what happened
  • Maintenance and repair records for the cooling equipment and the monitoring system

GDP 3.3.1

Computerised systems: validated and protected

What it says

Before you use a computerised system, show through validation or verification that it can achieve the intended results accurately, consistently and reproducibly. Keep a written description of the system. Only authorised people may enter or change data, and the data must be protected against deliberate or accidental change. Back the data up at regular intervals and keep the backups for at least five years at a separate, secure location.

What it means on site

Older monitoring software often runs on one PC under a desk, with shared logins and no backup. If that PC fails, the records for your next inspection can go with it.

How to evidence it

  • Validation or qualification records for the monitoring system (IQ, OQ, PQ)
  • A system description: what is monitored, where the data goes, who has access
  • User accounts and roles, with an audit trail of changes
  • How and where data is backed up, and for how long

GDP 9.2

Transport: the same control on the road

What it says

Maintain the required storage conditions during transport, within the defined limits stated by the manufacturer or on the outer packaging. If an excursion happens in transit, report it to the distributor and the recipient. Have a procedure for investigating and handling temperature excursions.

What it means on site

Vehicles are often monitored on a different system from the warehouse, or not at all. When an excursion happens on a delivery, the record needs to show the start, the peak, the duration and what was done.

How to evidence it

  • Monitoring records for each vehicle or shipper, linked to deliveries
  • Your written procedure for transport excursions
  • Records of excursions reported to the distributor and the recipient

GDP chapter 2

Quality oversight: the Responsible Person decides

What it says

Your Responsible Person makes sure the quality system is in place and working. For temperature, that means each excursion is reviewed and the decision on the affected stock is recorded.

What it means on site

Without the start time, the peak, the duration and the action on record, your RP can't release or reject the stock with confidence, and the decision can't be shown to an inspector later.

How to evidence it

  • An excursion record with readings, alarm, response and root cause
  • The RP's decision on the stock, signed and dated
  • Trends: repeat excursions on the same unit and what was changed

In the inspector's words

Questions to be ready for

The kind of questions an inspector, assessor or auditor puts. If you can answer each with a record, you're ready.

  1. “Show me the mapping for this room. Where are your probes, and why there?”
  2. “When did you last test this alarm, and what happened?”
  3. “Is this the sensor on this certificate?”
  4. “Who can change the alarm limits, and where would I see that they did?”
  5. “Talk me through your last excursion. What did your RP decide?”
  6. “How do you know the conditions held on this delivery?”

Where JTF fits

Where JTF fits

We map your storage as a managed service, place monitoring at the extremes the study finds, and provide calibration for every sensor we supply: traceable to national standards as standard, or UKAS accredited where you need it (temperature in our own UKAS accredited calibration laboratory No. 10723; other parameters through accredited partners). Sematics, our monitoring platform, keeps every reading, alarm, response and sign-off on one record your RP can review. Our UKAS accreditation covers temperature calibration; mapping and monitoring are carried out to the guidelines and the protocol we agree with you.

Checklist

MHRA GDP and Green Book temperature checklist

This page on one A4 sheet, plus the Green Book's rules for vaccine fridges.

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The 20-minute compliance check

See your own gaps, in writing

A free call with one of our specialists, then a branded report of what an inspector would find, yours to keep. This is an example.

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Example reportExample report: MHRA GDPA pharmaceutical wholesaler (fictional)Download the PDF
Example report: MHRA GDP
Page 1 of the example report: mhra gdpPage 2 of the example report: mhra gdpPage 3 of the example report: mhra gdp

Related

Keep reading

Questions

Common questions

Does GDP require continuous monitoring?

The guidelines don't use the word. They do require alarms that alert you to excursions from pre-defined storage conditions (3.3), which a manual check can't do overnight or at a weekend.

How long should we keep temperature records?

GDP asks for backups of computerised data to be kept for at least five years (3.3.1), and for distribution records to be kept for at least five years.

Does the mapping have to be UKAS-accredited?

The guidelines ask for mapping under representative conditions; they don't ask for an accredited study. Calibration of the monitoring equipment must be traceable to national or international standards.

Does this apply to GP practices and pharmacies?

GDP is for wholesale distribution. Vaccine fridges in GP practices and pharmacies follow the Green Book, chapter 3, which our checklist also covers.

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Sources

  1. EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01), applied in Great Britain by the MHRA
  2. MHRA: Good manufacturing practice and good distribution practice (GOV.UK)
  3. The Human Medicines Regulations 2012, regulation 43 (wholesale dealer licence holders)

This summary isn't official guidance. The source documents are what an inspector works from.

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