PDA TR 52

This technical report describes the overall quality system for distribution of pharmaceutical products and is meant to assist manufacturers in assuring that quality, integrity, and efficacy of the product are not compromised in the distribution channels, including handling, storage, transportation and distribution. It applies to all parties involved, including, but not limited to, the manufacturer, the holder of the marketing authorization, third party Logistics Service Providers (termed 3PLs), wholesale distributors, and transportation carriers. Anyone involved with the shipping and distribution of pharmaceutical products will benefit from Technical Report No. 52: Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain.