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Q11 Development and Manufacture of Drug Substances November 2012

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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