Links - 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 and 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.

On this Internet page by FDA you can find all Guides to Inspections providing interpretation guidance e. g. on the validation of computer systems, on cleaning validation or on sterile manufacture.

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 Guidelines as well as Question and Answer Documents about GMP related topics including information about GMP Inspection procedures
 

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 will find:
Manual of Policies and Procedures: Training and Communications; Formal Meetings between CDER and CDER's External Constituents, MAPP 4512.1.

IMDRF (International Medical Device Regulators Forum) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence. IMDRT publishes a number of GMP relevant Guidelines.