GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs

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US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application
Part 58 - Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
Part 600 - Biological Products: General
Part 601 - Licensing Biologics
Part 610 - General Biological Products Standards
Part 820 - Quality Systems Regulations


















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