GMP - PAT Handbook

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 Parts:

• Part 11 - Electronic Records; electronic Signatures – Scope and Application
• ICH Guideline on GMP for Active Pharmaceutical Ingredients (ICH Q7)
• 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