GMP Publications - Code of Federal Regulation Handbooks by the FDA

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

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978-1-935131-34-2

US FDA Title 21 CFR Parts

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

Canadian GMP - GUI-0001

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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