EU guide to good manufacturing practice for medicinal products for human and veterinary use

This brochure contains the second official edition of the EU Guide to Good Manufacturing Practice (GMP), the corresponding Commission Directives for GMP for medicinal products and investigational medicinal products for human use and for veterinary medicinal products as well as a glossary. Having been restructured in 2005 and further revised later on, the current EU GMP Guide comprises three parts: Part I Basic Requirements for Medicinal Products, Part II Basic Requirements for Active Substances used as Starting Materials, and Part III GMP Related Documents. The Annexes 1 to 19 cover additional requirements relevant to specific areas. The latest revisions concern the Chapters 2, 3, 5, 6 and 8 (in Part I), Part II and the Annexes 15 and 16. This edition has been extended by the Commission Delegated Regulation (EU) No. 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use - applicable from 25 May 2015.