GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook

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978-1-935131-29-8

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
Part 820 - Quality Systems Regulations

Auditor's Check Lists

Part 11 Electronic Systems Auditor's Checklist
GMP Auditor's Checklist
Quality Systems Regulation Auditor Checklist

















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