GMP Publications - Code of Federal Regulation Handbooks by the FDA

Clinical Manufacturing Handbook

Clinical-Manufacturing-Handbook

Clinical (IP) Manufacturing Handbook

Over 450 pages of Federal Laws, and Guidance for manufacturers of Clinical Investigational Products (IP).

Covers Pharmaceuticals, Devices and Biologics and includes the predicate rules.

• 21 CFR Part 11, Electronic Records; Electronic Signatures,
• 21 CFR Parts 210/211, Drug GMPs,
• 21 CFR Parts 600, General Biologic, 601 Licensing, 610 Biologic GMPs
• 21 CFR Part 820, Quality System Regulations
• cGMPs for Phase 1 Investigational Drugs, July 2008
• EU EudraLex - Volume 4 - Good Manufacturing Practice (GMP)
   - Chapter 1 - Pharmaceutical Quality System
   - Chapter 2 - Personnel
   - Chapter 3 - Premise and Equipment
   - Chapter 4 - Documentation
   - Chapter 5 - Production
   - Chapter 6 - Quality Control
   - Chapter 7 - Outsourced activities
   - Chapter 8 - Complaints and Product Recall
   - Chapter 9 - Self Inspection
• Annex 1 Manufacture of Sterile Medicinal Products
• ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients


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