Medicinal product is not cargo with a temperature requirement attached. It is a regulated article whose distribution history is part of its quality record. We run the pharmaceutical lanes on that basis.
Qualification, not calibration
Every chamber, vehicle and shipper on a pharmaceutical lane is qualified: mapped empty and loaded, in summer and winter conditions, with the mapping report held on file and re-executed on a defined cycle. Calibration of the probes is the easy part. Qualification of the environment they sit in is the work.
The documentation set
- Temperature mapping report per chamber and per vehicle type.
- Route qualification covering worst-case ambient and worst-case dwell.
- Deviation log with root cause and CAPA closure for every excursion.
- Released record per consignment, countersigned at the point of delivery.
Excursion handling
An excursion is not a failure of the service. It is an event that must be detected, quarantined, investigated and closed. Product that leaves the band is held pending assessment rather than delivered and explained afterwards. The trace on this page shows a genuine 8.6 °C peak from a receiving-bay door event: detected, flagged, quarantined and released after assessment against the product stability data.
The regulator does not ask whether you had an excursion. It asks what you did about the one you had.
