GMP References

GMP Reference and Guidance Documents

A great collection of source documents from the FDA, standards organizations, and industry associations. Take the mystery out of the regulations by finding out what they really say and mean. Most of these documents are free.

American National Standards Institute (ANSI)

American Society for Quality (ASQ)

American Society for Testing & Materials (ASTM)

Biotechnology Industry Organization (BIO)

Code of Federal Regulations (CFR) Titles

Drug Information Association (DIA)

FDA Center for Devices and Radiological Health (CDRH) Guidelines

FDA Center for Drug Evaluation and Research (CDER) Regulatory Guidance - your starting point for searching their guidance and enforcement

FDA Code of Federal Regulations (CFR) and ICH Handbooks from GMP Publications, Inc.

FDA - "A risk-based approach to pharmaceutical current Good Manufacturing Practices (cGMP) for the 21st century - previous reports, guidances, and additional information"

FDA Foreign Language documents and ICH information

FDA Warning Letters

Food and Drug Law Institute (FDLI)

International Society for Pharmaceutical Engineers (ISPE)

International Standards Organization (ISO)

Medical Device Manufacturers Association (MDMA)

National Institute of Standards and Technology (NIST)

Pharmaceutical Distribution Security Alliance (PDSA)

Pharmaceutical Research and Manufacturers of America (PHRMA)

Regulatory Affairs Professionals Society (RAPS) - Regulatory Focus - News

United States Pharmacopeia (USP)

revised 1/21/2016