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Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals

Date: May 08, 2000


HUMAN DRUG CGMP NOTES is a periodic memo for FDA personnel on Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals, issued by the Division of Manufacturing and Product Quality, HFD-320, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855.

This level 2 guidance document represents the agency's current thinking on Current Good Manufacturing Practice for human use pharmaceuticals. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

The memo is an internal FDA issuance intended to enhance field/headquarters communications on CGMP issues in a timely manner. The document is a forum to hear and address CGMP questions, provide updates on CGMP projects, and clarify and help apply existing policy to day to day activities of FDA staff.

HUMAN DRUG CGMP NOTES does not supplant existing policy development/issuance mechanisms. Although our intended readership is FDA field and headquarters personnel, many people in the pharmaceutical industry have expressed significant interest in the document. Whereas we cannot currently extend our distribution list, for the paper edition, to non-FDA personnel, the memo is fully releasable under the Freedom of Information Act. In addition, we are making the issuance available electronically to interested persons outside FDA. For additional information contact C. Russ Rutledge: phone (301) 594-2455; FAX (301) 594-2202; Internet e-mail at rutledgec@cder.fda.gov; or paper mail at the above address.

 

Human Drug CGMP Notes -2000

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Human Drug CGMP Notes -1996

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Human Drug CGMP Notes -1995

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