Current Edition

Good Distribution Practices – Why and to What Detail GDP-contracts between Sponsors/Manufacturers and Distributors are Needed

A revision of the European GDP-guideline has been published for public consultation on December 31, 2011. Although defining the requirements for the wholesale distribution of medicinal products, the guideline is a useful guide for defining rules and roles in the distribution chain of investigational medicinal products. Claudio Lorck at Temmler Werke GmbH describes the reasons for having quality agreements with distribution/transport companies, and the main topics to be described for distribution of IMPs without usage of a depot.