| The Human Drug CGMP Notes is no longer being published. It was published from 1993-2003 as a periodic memo for FDA personnel intended to enhance field and headquarters communications on CGMP issues in a timely manner. The Notes was issued by the Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. FDA. Editions published during 2001 to 2003 were distributed internally and only made publicly available by a Freedom of Information Act request.
FDA has created the web site Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs for posting answers to questions about the CGMP regulations, statute, and related guidance. The format for these "Questions and Answers" is similar to the Notes and now includes participation by the other drug product centers in FDA, the Center for Veterinary Medicine and the Center for Biologics Evaluation and Research. Each answer is approved for posting in accordance with the good guidance practices regulations at 21 CFR 10.115.
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