Human Drug CGMP Notes
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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Human Drug CGMP Notes -2000 (Choose the version that fits your needs) |
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Human Drug CGMP Notes -1999 (Choose the version that fits your needs) |
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Human Drug CGMP Notes -1995 (Choose the version that fits your needs) |
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