US, Canada GMPs, ICH Q7, Q8, Q9 & Q10

Title 21 CFR Parts:

• 21 CFR Part 11 - Electronic Records/Electronic Signatures (ERES)
• 21 CFR Part 11 - Scope & Application 2003
• 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