GMP Publications - Code of Federal Regulation Handbooks by the FDA

EU and US GMPs with Annexes 11 and 15

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978-1-935131-53-3

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 Systems Regulations

European Union

The EU GMPs include Chapters 1-9 - EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

European Union (EU) Annexes

Annex 11 - Computerized Systems
Annex 15 - Qualification and Validation















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