Regulations
What your inspector will ask about temperature, and how to show it
Each guide sets out what the rule says, what it means on site and the evidence an inspector, assessor or auditor expects, with the clause numbers. Written by the team that monitors 350+ UK sites and runs its own UKAS accredited calibration laboratory No. 10723.
The rules explained
Pick the rule you're inspected against
Most sites answer to one or two of these. Each guide starts with the short answer.
MHRA GDP
For WDA holders: mapping, monitoring, alarms, calibration, computerised systems and transport excursions.
Read the guideEU GMP and the Orange Guide
For manufacturers: storage, calibration, Annex 15 mapping and requalification, stability chambers, Annex 1 and record retention.
Read the guideGreen Book chapter 3
For GP practices, pharmacies and clinics: vaccine fridges at 2 to 8 °C, daily records and cold chain breaches.
Read the guideISO 15189
For medical laboratories: monitoring, traceable calibration, uncertainty and alarm limits in a UKAS assessment.
Read the guideISO/IEC 17025
What an accredited calibration means, and how to read the certificate before you file it.
Read the guideBRCGS
For food sites and cold stores: temperature limits, monitoring, calibration and corrective action at audit.
Read the guideEU GMP Annex 11 (computerised systems)
What a validated monitoring system looks like: data integrity, audit trails, access and backups.
Read the guideTemperature excursions
For every sector: what to do and record when storage goes out of range, from alarm to sign-off.
Read the guide
Checklists
The rules on one page
Free A4 checklists with the clauses, so you can see your gaps before an inspection or assessment.
- Checklist
MHRA GDP and Green Book temperature checklist
For WDA holders, pharmacies and GP practices: storage, mapping, alarms and excursion records.
Download the PDF - Checklist
ISO 15189 temperature checklist
For medical laboratories preparing for a UKAS assessment: monitoring, calibration, uncertainty and records.
Download the PDF
Sources
- EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01), applied in Great Britain by the MHRA
- UKHSA, The Green Book, chapter 3: Storage, distribution and disposal of vaccines
- ISO 15189:2022 Medical laboratories: requirements for quality and competence
- ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
- BRCGS Global Standard for Food Safety, Issue 9
- EudraLex Volume 4, Annex 11: Computerised Systems
20-minute compliance check
Want to know where your gaps are?
In 20 minutes we look at how you prove temperature to your inspector or auditor, and where the gaps are. You get a short list of what to fix first. No product tour.