通用技术文档(CTD)模块3:质量部分CMC中英文目录-夜雨聆风

通用技术文档(CTD)模块3:质量部分CMC中英文目录

Module 3: Quality模块3：质量

3.1 模块3的目录

3.1 Table of Contents of Module 33.1 模块3目录

3.2 主体数据

3.2 Body of Data3.2 主体数据

3.2.S 原料药

3.2.S Drug Substance3.2.S 原料药

编号	英文	中文
3.2.S.1	General Information	基本信息
3.2.S.1.1	Nomenclature	命名
3.2.S.1.2	Structure	结构
3.2.S.1.3	General Properties	一般性质
3.2.S.2	Manufacture	生产
3.2.S.2.1	Manufacturer(s)	生产商
3.2.S.2.2	Description of Manufacturing Process and Process Controls	生产工艺和过程控制的描述
3.2.S.2.3	Control of Materials	物料控制
3.2.S.2.4	Controls of Critical Steps and Intermediates	关键步骤和中间体的控制
3.2.S.2.5	Process Validation and/or Evaluation	工艺验证和/或评价
3.2.S.2.6	Manufacturing Process Development	生产工艺的开发
3.2.S.3	Characterisation	表征
3.2.S.3.1	Elucidation of Structure and Other Characteristics	结构解析及其他特性
3.2.S.3.2	Impurities	杂质
3.2.S.4	Control of Drug Substance	原料药的质量控制
3.2.S.4.1	Specification	质量标准
3.2.S.4.2	Analytical Procedures	分析方法
3.2.S.4.3	Validation of Analytical Procedures	分析方法的验证
3.2.S.4.4	Batch Analyses	批分析
3.2.S.4.5	Justification of Specification	质量标准的制定依据
3.2.S.5	Reference Standards or Materials	对照品
3.2.S.6	Container Closure System	包装系统
3.2.S.7	Stability	稳定性
3.2.S.7.1	Stability Summary and Conclusion	稳定性总结和结论
3.2.S.7.2	Post-Approval Stability Protocol and Stability Commitment	批准后稳定性研究方案和承诺
3.2.S.7.3	Stability Data	稳定性数据

3.2.P 制剂

3.2.P Drug Product3.2.P 制剂

编号	英文	中文
3.2.P.1	Description and Composition of the Drug Product	剂型及产品组成
3.2.P.2	Pharmaceutical Development	产品开发
3.2.P.2.1	Components of the Drug Product	处方组成
3.2.P.2.1.1	Drug Substance	原料药
3.2.P.2.1.2	Excipients	辅料
3.2.P.2.2	Drug Product	制剂
3.2.P.2.2.1	Formulation Development	处方开发
3.2.P.2.2.2	Overages	过量投料
3.2.P.2.2.3	Physicochemical and Biological Properties	理化和生物学特性
3.2.P.2.3	Manufacturing Process Development	生产工艺的开发
3.2.P.2.4	Container Closure System	容器密封系统
3.2.P.2.5	Microbiological Attributes	微生物属性
3.2.P.2.6	Compatibility	相容性
3.2.P.3	Manufacture	生产
3.2.P.3.1	Manufacturer(s)	生产商
3.2.P.3.2	Batch Formula	批处方
3.2.P.3.3	Description of Manufacturing Process and Process Controls	生产工艺和工艺控制的描述
3.2.P.3.4	Controls of Critical Steps and Intermediates	关键步骤和中间体的控制
3.2.P.3.5	Process Validation and/or Evaluation	工艺验证和/或评价
3.2.P.4	Control of Excipients	辅料的控制
3.2.P.4.1	Specifications	质量标准
3.2.P.4.2	Analytical Procedures	分析方法
3.2.P.4.3	Validation of Analytical Procedures	分析方法的验证
3.2.P.4.4	Justification of Specifications	质量标准的制定依据
3.2.P.4.5	Excipients of Human or Animal Origin	人源或动物源辅料
3.2.P.4.6	Novel Excipients	新型辅料
3.2.P.5	Control of Drug Product	制剂的质量控制
3.2.P.5.1	Specification(s)	质量标准
3.2.P.5.2	Analytical Procedures	分析方法
3.2.P.5.3	Validation of Analytical Procedures	分析方法的验证
3.2.P.5.4	Batch Analyses	批分析
3.2.P.5.5	Characterization of Impurities	杂质分析
3.2.P.5.6	Justification of Specification(s)	质量标准的制定依据
3.2.P.6	Reference Standards or Materials	对照品
3.2.P.7	Container Closure System	容器密封系统
3.2.P.8	Stability	稳定性
3.2.P.8.1	Stability Summary and Conclusion	稳定性总结和结论
3.2.P.8.2	Post-Approval Stability Protocol and Stability Commitment	批准后稳定性研究方案和承诺
3.2.P.8.3	Stability Data	稳定性数据

3.2.A 附录

3.2.A Appendices3.2.A 附录

编号	英文	中文
3.2.A.1	Facilities and Equipment	设施和设备
3.2.A.2	Adventitious Agents Safety Evaluation	外源因子安全性评价
3.2.A.3	Excipients	辅料

3.3 参考文献

3.3 Literature References3.3 参考文献