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Links - Documents

FDA CGMP

GMP Guides from Industry Organisations

Pharmacopoeias

  • Documents have to be ordered
  • Documents can be downloaded

Links - GMP-Regulations

21 CFR 210 of the „Code of Federal Regulations“ regulates the US requirements for Food and Drugs. GMP requirements for finished pharmaceuticals can be found at Part 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 will find the Notice for Applicants for Human Pharmaceuticals issued by the EC.

Here you will find Quality, Biotechnology, Safety, Environment and Clinical Guidelines.

Here you will find Guidelines as well as Question and Answer Documents about GMP related topics including information about GMP Inspection

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.

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.

Links - Pharmaceutical Associations

The association of Pharmaceutical Research and Manufacturers of America (PhRMA) also has a section on its homepage commenting on current regulatory developments, e.g. new FDA Guidelines.

IPEC, the International Pharmaceutical Excipients Council is the world wide Trade Association of Manufacturers and users of Pharmaceutical Excipients.

The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) represents the worldwide research-based pharmaceutical industry and manufacturers of prescription medicines generally.

The European Chemical Industry Council is both the forum and the voice of the European chemical industry. It represents, directly or indirectly, about 40,000 large, medium andsmall chemical companies in Europe, which employ about two million people and account for more than 30% of world chemicals production.

Here you can find the European Federation of Pharmaceutical Industries and Associations.

Links - Regulatory Authorities

Here you will find the homepage of the European regulatory authority EMA.

Here you will find the supreme regulatory authorities of the various European member states.

The European Commission Public Health provides the legal framework for the pharmaceutical legislation in Europe.

At this address you will find the British Medicines and Healthcare products Regulatory Agency (MHRA).

Here you will find the homepage of the US Food and Drug Administration.

Links - Others

The API Compliance Institute has been founded to organise Third Party GMP Audits according to APIC Auditing Programme.

The Pharmaceutical Consulting Alliance is a leading Consulting Company in the field of GMP and Regulatory Compliance.

International Pharmaceutical Quality (IPQ) is one of the most important publications in the GMP environment. Each story provides an in-depth analysis of a key problem area or developing regulatory initiative. IPQ seeks to improve understanding of the issues and aid the development of harmonized global CMC and GMP policies and corporate quality systems.