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GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP - PAT Handbook

978-1-935131-31-1

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 System Regulation

FDA Guidance for Industry

Part 11 - Electronic Records; electronic Signatures – Scope and Application
ICH Guideline on GMP for Active Pharmaceutical Ingredients (ICH Q7)
Current Good Manufacturing Practices (cGMP) for Drugs Auditor’s Check List
PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
Drug Manufacturing Inspections: Compliance Manual for FDA Staff (7356.002)
Quality Systems Approach to Pharmaceutical CGMP Regulations

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