Definition

Standards for the distribution of medicinal products to ensure quality and integrity are maintained through the supply chain, including storage and transport.

Example

Wholesalers and distributors must hold a GDP authorisation and comply with temperature control, traceability, and recall procedures.

Regulatory source

EU GDP Guidelines, WHO GDP

Common mistakes

Failing to qualify transporters or to monitor temperature during shipping. Incomplete documentation for receipt and dispatch.

Inspector question

How do you qualify and monitor your distribution partners and transport conditions?

Related terms