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GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP Manufacturing Handbook

GMPManufacturing

GMP Manufacturing Handbook

Over 450 pages of Federal Laws, and Guidance for manufacturers. 

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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