Storing medicines and vaccines: what the GDP guidelines and the Green Book expect
A summary of the source documents, which inspectors work from. Part A is for wholesale distribution (WDA holders). Part B is for vaccine fridges in pharmacies and GP practices.
Part A: GDP for WDA holders
(EU GDP guidelines 2013/C 343/01, applied in Great Britain by the MHRA; Human Medicines Regulations 2012, reg. 43)
Storage areas (3.2.1)
- Map each storage area before use, under representative conditions.
- Place the monitoring where the mapping found the extremes.
- Re-map after significant changes to the facility or the cooling equipment, or as your risk assessment sets.
- For small rooms at room temperature, assess the risks (heaters, for example) and place the monitors to match.
Equipment (3.3)
- Calibrate the monitoring equipment at defined intervals, set by risk, and traceable to national or international standards.
- Have alarms that alert you to excursions from the storage conditions, with levels set appropriately.
- Test the alarms regularly, and keep the record.
- Carry out repairs and calibration without putting stock at risk, and keep records.
Computerised systems (3.3.1)
- Validate the monitoring system before use, and keep a written description of it.
- Only authorised people can enter or change data, and the data is protected.
- Back up the data at regular intervals, and keep the backups for at least five years.
Transport (9.2)
- Hold the storage conditions in transit.
- Report any excursion to the distributor and the recipient.
- Have a written procedure for investigating and handling temperature excursions.
Quality oversight (chapter 2)
- Your Responsible Person reviews each excursion and records the decision on the stock.
Part B: Vaccine fridges
(UKHSA, the Green Book, chapter 3)
The fridge
- Use a specialised pharmaceutical fridge. Ordinary domestic fridges must not be used.
- Store no food, drink or clinical specimens with the vaccines.
- Give each fridge a unique ID, keep it locked or in a locked room, leave room for air to circulate, and protect the plug.
- Have a maintenance contract with at least yearly servicing and calibration of the temperature gauge.
- Keep records of servicing, defrosting, cleaning, calibration and electrical testing.
Monitoring
- Keep +2 °C to +8 °C, aiming for +5 °C.
- Use at least one max–min thermometer that is independent of mains power, calibrated annually.
- Read and record at least once each working day, at the same time, on a standard form, and sign each entry.
- Follow the four Rs: read, record, reset, react. Reset after each reading, and act on anything outside +2 °C to +8 °C, recording what you did.
- Keep the records for at least one year. Five years will generally cover a vaccine's full storage history.
If the fridge fails or goes out of range
- Keep the door closed until you've assessed the situation.
- Find the last reliable reading, and the time and cause of the change.
- Quarantine the affected vaccines in the cold chain, labelled, and don't use them until advised.
- Report it through your local incident scheme, and record every detail.
Where a logger helps:
- A max–min thermometer shows the extremes since the last reset, but not when they happened or for how long.
- A continuous logger shows both, which is what an incident assessment needs.
Sources:
Want us to go through it with your records?
Book a free 20-minute compliance check: we look at your current records, alarms and calibration against this list and tell you what an inspector would ask about. Book a 20-minute check or call 0121 794 8092.
