Quality through procedures and documented evidence

Regular GDP training addresses the handling of pharmaceutical products at the different stages of transport. Staff knowledge forms part of transport preparation alongside equipment and documented procedures. Discussions about quality should therefore consider both product handling and the conditions required during carriage.

Temperature mapping and validation are carried out regularly for vehicles and containers. The quality management system also includes internal audits and ongoing process improvement. These activities concern how transport is organised and how pharmaceutical distribution standards are followed throughout the operation.

The procedures apply to a carton of samples as well as a full load of medicines. The products being carried are connected to people's health and well-being. Quality discussions should therefore relate to the actual cargo and the documentation of its handling.

A documented chain of custody starts when the shipment is collected from the customer. Any deviation is recorded, investigated and addressed in a report. Contingency plans include backup cooling and alternative routing. When assessing the process, consider the transport documentation alongside the account of any such events.

Shipments are covered by carrier's liability insurance. Additional cover is available for products with a high value, and insurance documents can be supplied on request. If these matters are relevant to your planned transport, include them in the questions you prepare about the particular shipment.

Prepare questions about insurance documents and possible additional cover for high-value products. You can also discuss chain of custody records and deviation reporting. This provides a basis for considering both quality procedures and available insurance arrangements in relation to the cargo concerned.