GMP

GMP Regulations

	Part 21 of the “Code of Federal Regulations” defines the GMP requirements of the USA for the manufacture of medicinal products and pharmaceutical substances. The current GMP (cGMP) can be found at the following links: 21 CFR 210 21 CFR 211 Here you can download almost all FDA guidelines of CDER (Human Drugs) directly and free of charge from the internet. In addition, new GMP developments will be announced promptly and new drafts published. Here you can download almost all FDA guidelines of CBER (Biologics) directly and free of charge from the internet. In addition, new GMP developments will be announced promptly and new drafts published. Sie finden auf dieser Internetpage der FDA sämtliche Guides to Inspections, die Interpretationshilfen z.B. zur Validierung von Computersystemen, zur Reinigungsvalidierung oder zur Sterilherstellung geben. Here you will find the EC-GMP Guide and the 18 annexes. Here you also find the EC Directives 91/356 and 91/412 which constitute the foundation for the GMP Guide. Here you will find the regulations and directives applicable in the EU for human pharmaceuticals. Here you will find the Notice for Applicants for Human Pharmaceuticals issued by the EC. Here you will find Quality, Biotechnology, Safety, Environment and Clinical Guidelines issued by the EC. Here you will find the regulations and directives applicable in the EU for veterinary pharmaceuticals.. Here you will find the Notice to Applicants for Veterinary Pharmaceuticals issued by the EC. Here you will find the Guidelines for Efficacy Testing, Environmental Risks, Production and Control of Immunological Veterinary Pharmaceuticals and Quality Guidelines. Here you will find Guidelines concerning EMEA, e.g. Guidelines for the Blood Products Working Party, Biotechnology Working Party Guidelines, Quality Working Party Guidelines, etc. Here you can order the European Pharmacopoeia. Here you will find the website of the Pharmaceutical Inspection Convention Scheme (PIC/S).   Here you can download the ICH Guidelines from the internet free of charge. You can follow the current status of new ICH Guidelines here. You will find the Division of Drug Management and Policies of the World Health Organization (WHO) here. On this page you will find information on Guidelines, Certification Scheme, International Pharmacopoeia, etc. Here you can download the Medizinproduktegesetz (German Law on Medical Devices). Here you will find:  Manual of Policies and Procedures: Training and Communications; Formal Meetings between CDER and CDER’s External Constituents, MAPP 4512.1. Here you will find: Prescription Drug User Fee Program (PDUFA) in the FDA Modernization Act of 1997: PDUFA Reauthorization Performance Goals and procedures Section III “Meeting Management Goals”.