GMP Publications - Code of Federal Regulation Handbooks by the FDA

ICH Q7, Q8, Q9, Q10 and Q11

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978-1-935131-62-5

International Conference on Harmonisation Regulations

ICH Q7 - GMP Guide for Active Pharmaceutical Ingredients
ICH Q8(R2) - Pharmaceutical Development
ICH Q9 - Quality Risk Management
ICH Q10 - Pharmaceutical Quality System
ICH Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)























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