GMP Publications - Code of Federal Regulation Handbooks by the FDA

EU and US GMPs with Annex 1

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978-1-935131-55-7

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

The EU GMPs include Chapters 1-9 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary
Includes Annex 1 Sterile Medicinal Products.

ICH Q7 - Good Manufacturing Practices



















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