Issue Date: November 20, 2012
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q11 Development and Manufacture of Drug Substances
This guidance describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) sections 3.2.S.2.2 – 3.2.S.2.6 (see the ICH guidance M4Q: The CTD – Quality (ICH M4Q)). It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities. In addition, this guidance provides further clarification on the principles and concepts described in the ICH guidances, Q8 Pharmaceutical Development (ICH Q8), Q9 Quality Risk Management (ICH Q9), and Q10 Pharmaceutical Quality System (ICH Q10), as they pertain to the development and manufacture of drug substance. Additional Guidance Resources • Q11 Development and Manufacture of Drug Substances—Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)
Download the Guidance Document
