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23US11.210.211.CanadaGMPs.ICHQ7.8.9.10
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 July 2020

International Conference on Harmonisation Regulations

ICH Q7 - Good Manufacturing Practice guide for API
ICH Q8(R2) - Pharmaceutical Development
ICH Q9(R1) - Quality Risk Management
ICH Q10 - Pharmaceutical Quality System


















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