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GMP Publications - Code of Federal Regulation Handbooks by the FDA

ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination

ICHQ7.8.9.10.12

International Conference on Harmonisation Regulations

ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination

  • ICH Q7 – Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)
  • ICH Q8(R2) – Pharmaceutical Development
  • ICH Q9(R1) – Quality Risk Management
  • ICH Q10 – Pharmaceutical Quality Systems
  • ICH Q12 – Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
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