Ctd 3.2.s.2.3
Webm4q(r1)中“2.3质量综述”与80号文中的“药学信息汇总表”对比,显而易见的是多了2.3.a附录和2.3.r区域性信息,更多见识不到的是在2.3.s原料药、2.3.p制剂部分的分级没有80号文细化,因为核心不同,m4格式对于模块2的要求更强调“总结”,并不是过多的数据堆积 ... Webused in the manufacture of the drug substance, as described in 3.2.S.2.3; • A discussion of the selection and justification of critical manufacturing steps, process controls, and …
Ctd 3.2.s.2.3
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WebSep 12, 2016 · 3.2.s.4.5质量标准的论证。 3.2.s.5 标准品或标准物质的信息。单纯参考dmf是不够的; 3.2.s.6包装系统信息。对于无菌原料药,应包括对其包装系统的描述以及对包装系统完整性的验证; 3.2.s.7 稳定性相关信息。包括原料药复验期或有效期。 2. 制剂部 …
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