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2. Current Good Manufacturing Practice (CGMP) Regulations | FDA

   www.fda.gov/.../current-good-manufacturing-practice-cgmp-regulations

   This web page provides links to resources to help drug manufacturers comply with the CGMP regulations; including guidance documents, federal regu Regulations help to ensure quality drug...

3. Facts About the Current Good Manufacturing Practice (CGMP) | FDA

   www.fda.gov/.../facts-about-current-good-manufacturing-practice-cgmp

   The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals. Consumers expect that each batch...

4. Guidance for Industry, Q7A Good Manufacturing Practice Guidance...

   www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance...

   This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for...

5. eCFR :: 21 CFR Part 211 -- Current Good Manufacturing Practice...

   www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211

   Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

6. CFR - Code of Federal Regulations Title 21 - Food and Drug...

   www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.1

   Sec. 210.1 Status of current good manufacturing practice regulations. (a) The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contain the minimum current good...

7. CFR - Code of Federal Regulations Title 21 - Food and Drug...

   www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=210

   For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 210.1 - Status of current good manufacturing practice regulations. § 210.2 -...

8. The Electronic Code of Federal Regulations - eCFR

   www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210

   (a) The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to ...

9. Current Good Manufacturing Practices (CGMPs) for Food and Dietary...

   www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good...

   CGMP regulations generally address matters including appropriate personal hygienic practices, design and construction of a food plant and maintenance of plant grounds, plant equipment, sanitary...

10. CFR - Code of Federal Regulations Title 21 - Food and Drug...

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211

    The information on this page is current as of Aug 30, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 211.1 - Scope. § 211.3 -...

11. eCFR :: 21 CFR Part 211 -- Current Good Manufacturing Practice...

    www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211?toc=1

    General requirements. § 211.82: Receipt and storage of untested components, drug product containers, and closures. § 211.84: Testing and approval or rejection of components, drug product containers, and closures. § 211.86: Use of approved components, drug product containers, and closures. § 211.87