FDA: Q11 Development and Manufacture of Drug Substances

This guideline describes approaches to developing process and drug substance 66 understanding and also provides guidance on what information should be provided in 67 CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles 68 and concepts described in ICH guidelines on Pharmaceutical Development (Q8), 69 Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they 70 pertain to the development and manufacture of drug substance.