The EU Good Distribution Practice guidelines (2013/C 343/01, chapter 9) call for qualified equipment for temperature-sensitive medicines and for the storage conditions stated on the packaging to be held throughout transport. A specification therefore buys qualification rather than a box: under what conditions, at what load and after how many repeats it holds, and for how long.
| Clause | What the specification states |
|---|---|
| Target range | Lower and upper limit of the labelled storage condition together; freezing harms the product as much as heat |
| Qualification report | Summer and winter profile, duration, fill ratio, number of repeats, sensor points, raw record |
| Instructions for use | How many plates, placed where, frozen how long before; fixed permanently to the container |
| Coolant | Plates never touch the medicine; frozen and chilled plates are kept apart |
| Logger | Recording interval, readable report format, calibration at least once a year |
The guidelines tie container choice to the expected outside temperature extremes and the longest transport time. Ask for the report at the fill ratio your institution will use, and validate in the hottest month on the longest route. When a limit is exceeded or data is missing, the quality owner decides whether the product is used.
