For WDA holders, pharmacies and GP practices
MHRA GDP temperature checklist
One A4 page on what the GDP guidelines and the Green Book expect for storing medicines and vaccines: mapping, monitoring, alarms, calibration, and what to do when a fridge goes out of range. Free to download.
- GDP chapters 3 and 9, in plain English
- The Green Book's four Rs for vaccine fridges
- What to record during an excursion
The usual gaps
Where inspections go wrong
- 01
A daily reading that misses the night.
The Green Book asks for a reading each working day. A min/max shows the extremes, but not when they happened or for how long.
- 02
No excursion procedure.
GDP 9.2 asks for a procedure for investigating and handling excursions. Too often the first one is written during the incident.
- 03
The wrong fridge.
The Green Book says ordinary domestic fridges must not be used for vaccines.
How JTF does it
One team, three steps
- 01
Storage and mapping
Mapping before use, monitoring at the extremes, and re-mapping after significant changes.
- 02
Monitoring, alarms and calibration
Alarm levels set and tested, and calibration traceable to national standards.
- 03
Excursions and records
What to do first, what to record, and how long to keep it.
“Sematics has completely taken the stress out of temperature monitoring.”
Questions
Before you book
Is this official MHRA guidance?
No. It's a summary of the GDP guidelines and the Green Book, chapter 3, with links to both. The source documents are what an inspector works from.
Does it apply to GP practices?
The Green Book section does. The GDP section is for wholesale distribution (WDA holders).
How long should we keep fridge records?
The Green Book says at least one year, and five years will generally cover a vaccine's full storage history. GDP asks for at least five years for distribution records.
Sources
- EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01), applied in Great Britain by the MHRA
- MHRA: Good manufacturing practice and good distribution practice (GOV.UK)
- The Human Medicines Regulations 2012, regulation 43 (wholesale dealer licence holders)
- UKHSA, The Green Book, chapter 3: Storage, distribution and disposal of vaccines
- UKHSA: Protocol for ordering, storing and handling vaccines
- CQC: GP mythbusters (includes vaccine storage)