Temperature monitoring during transport
Every temperature-sensitive shipment carries a calibrated logger placed with the product; the record is reviewed on receipt and excursions handled before release.
EU GDP chapter 9 requires that the required storage conditions are maintained during transport, and that temperature-sensitive products are shipped with monitoring where the route or product warrants it. In practice most cold-chain shipments carry a single-use or reusable logger.
Practical rules
- Position the logger where the shipper qualification showed the worst case, not on top of the outer packaging.
- Use loggers whose calibration covers the transport range, with a documented interval.
- Start the logger with a recorded time and, if possible, a stabilisation period before packing.
- On receipt: download, review against limits, and file the trace with the shipment record.
- Excursions: quarantine, assess with product data, document the decision.
Where loggers are reused, their calibration and battery status become part of the dispatch checklist.
Frequently asked questions
- Do ambient (15–25 °C) shipments need a logger?
- Where the route risk assessment indicates the range could be breached — summer road transport, air freight tarmac exposure — yes. The assessment must be documented.
References
- [1]EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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