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GMP Publications - Code of Federal Regulation Handbooks by the FDA

US and EU GMPs with ICH Q7, Q8(R2), Q9, Q10

US.EU-GMPs.ICHQ7.8.9.jpg
978-1-935131-96-0

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

European Union

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

International Conference on Harmonisation Regulations

ICH Q7 - Good Manufacturing Practice guide for API
ICH Q8(R2) - Pharmaceutical Development
ICH Q9 - Quality Risk Management
ICH Q10 - Pharmaceutical Quality System














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