Guidelines for Good Distribution Practices of Medical Products.

This document lays down guidelines for good distribution practices for medical products in order to facilitate efficient and effective distribution of medical products with assured quality, safety and efficacy. These guidelines apply equally to products for human and for veterinary use and cover products for which a prescription is required, products, which may be provided without a prescription, biologicals and vaccines.
The set guidelines include regulations concerning the distribution of medical products; the organizational structure and management of each entity including duties and responsibilities of all personnel, their training and qualifications; the quality assurance system in place in every organization; the premises, warehousing and storage; the vehicles and equipment used to distribute, store or handle medical products; the shipment of containers and the containers labelling; the dispatch and receipt to and from authorized people; the transportation pf products and the protection of products in transit; the documentation; the repackaging and labelling restrictions; the complaints; the recalls of medical products; the returned products; the counterfeit medical products; the contracts which must cover any activity relating to the distribution of a medical product which is delegated to another person; the self-inspection which is part of the quality assurance system.