Dear colleagues,

it is a common practice to introduce in the shipment boxes of clinical samples, dataloggers to record the temperature during transportation. My question is the following: is this practice mandatory? If the courier has validated the boxes, demonstrating that the system maintains the temperature for the expected duration of the transport at the expected conditions (or in "extreme" conditions), is it also mandatory to include a datalogger?

If so, could anyone indicate a reference document where this rule is stated? it could be a regulatory document, guideline, or a deviation reported by inspectors of GCP/GCLP.

Thank you in advance for your wise advice