The shipping, return and destruction of unused products should be carried out in accordance with the written procedures laid down in the protocol. All unused products sent outside the manufacturing plant should, as far as possible, either be returned to the manufacturer or destroyed in accordance with clearly defined instructions.
Investigational products should be shipped in accordance with the orders given by the sponsor.
A shipment is sent to an investigator only after the following two-step release procedure: (i) the release of the product after quality control ("technical green light"); and (ii) the authorization to use the product, given by the sponsor ("regulatory green light"). Both releases should be recorded.
The sponsor should ensure that the shipment will be received and acknowledged by the correct addressee as stated in the protocol.
A detailed inventory of the shipments made by the manufacturer should be maintained, and should make particular mention of the addressee's identification.
Investigational products should be returned under agreed conditions defined by the sponsor, specified in written procedures, and approved by authorized staff members.
Returned investigational products should be clearly identified and stored in a dedicated area. Inventory records of returned medicinal products should be kept. The responsibilities of the investigator and the sponsor are dealt with in greater detail in the WHO guidelines on GCP (3).
The sponsor is responsible for the destruction of unused investigational products, which should therefore not be destroyed by the manufacturer without prior authorization by the sponsor. Destruction operations should be carried out in accordance with environmental safety requirements.
Destruction operations should be recorded in such a manner that all operations are documented. The records should be kept by the sponsor.
If requested to destroy products, the manufacturer should deliver a certificate of destruction or a receipt for destruction to the sponsor. These documents should permit the batches involved to be clearly identified.