Guidelines for The Classification of Deficiencies Observed During Inspection of Drug Manufacturers

FDA CIRCULAR NO. 2019-003 14 FEB 2019 Subject:  GUIDELINES FOR THE CLASSIFICATION OF DEFICIENCIES OBSERVED DURING INSPECTION OF DRUG MANUFACTURE  ...
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Notice on the Adoption of the PIC/S Guide to GMP

Administrative Order (AO) No. 2012-008, or the rules on the “Adoption and Implementation of the Pharmaceutical Inspection Cooperation Scheme (PIC/S)...
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Creation of Technical Working Group for the Effective Implementation of the PICS/GMP Guide for Medicinal Products

FDA MEMORANDUM CIRCULAR NO. 2018-003 13 July 2018 TO : All Drug Establishments and concerned Offices, Officers, and Personnel within...
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Authority of FDA Inspectors

FDA Circular 2012-011   05 September 2012   TO: ALL FDA Inspectors and Drug Establishments   SUBJECT: Authority of FDA...
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