It provides further clarification on the principles and concepts described in guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance. English (EN) (538.36 KB - PDF) English (EN) (460.79 KB - PDF)

ich m4q推荐控制策略的每个要素在申报资料的合适章节进行报告，包括： 生产工艺的描述与工艺控制（3.2.s.2.2）； 物料控制（3.2.s.2.3）； 关键步骤和中间体的控制（3.2.s.2.4）； 原料药控制（3.2.s.4）； 容器密闭系统（3.2.s.6）。 7. 工艺验证/评价 7.1 总则

2023年11月1日 · Q11 Development and Manufacture of Drug Substances/化学药品的研发与生产

discussed in ICH Q8 for drug product, a greater understanding of the drug substance and its manufacturing process can create the basis for more flexible regulatory approaches. The degree of

addition, ICH Q11 provides further clarification on the principles and concepts described in ICH Guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) as they pertain to the development and

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...

ICH Q11 is applicable to drug substances as defined in the Scope sections of the ICH Q6A and Q6B guidances, but might also be appropriate for other types of products following consultation with...

This guidance was developed within the Q11 Expert Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH...

ich q11 中描述市售化学品的“非药用市场” 是为了排除那些声称作为市售化学品的中间 体。 ich q11 明确指出了市售化学品和定制 合成化学品之间的区别。如果使用市售化学品 作为起始原料，申请人通常不需要论证，而如 果使用了定制合成化学品作为起始原料 ...

2018年8月7日 · q11指南中规定质量风险管理可以在各种活动(包括生产工艺设计选择、评估质量属性以及确定生产工艺参数)中使用，从而保证正常生产批次产品的质量。