FDA 发布 Q11《原料药开发与生产》最终指南
Q11 Development and Manufacture of Drug Substances
FDA 发布 Q11《原料药开发与生产》最终指南，说明原料药生产工艺的开发与理解方法，并要求在 CTD 模块 3 第 3.2.S.2.2 至 3.2.S.2.6 节提供相应信息。指南涵盖原料药开发与生产的相关方面，包括为降低杂质而设置的步骤。该文件还对 ICH Q8、Q9、Q10 中涉及原料药开发与生产的原则和概念作进一步说明。
该最终指南说明原料药开发与生产工艺的理解方法，并界定 CTD 模块 3 第 3.2.S.2.2 至 3.2.S.2.6 节应提供的信息。
GUIDANCE DOCUMENT
Final
- Issued by:
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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.
来源：FDA Pharmaceutical Quality Documents · fda.gov