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质量实施工作小组关于 Q8,Q9 和 Q10 的问与答(R4)现行
目录
1. 简介 .............................................................................................................. 1
1.1 一般声明....................................................................................................2
2. 质量源于设计 ...........................................................................................3
2.1 设计空间....................................................................................................3
2.2 实时放行检测...........................................................................................5
2.3 控制策略.....................................................................................................8
3. 药品质量体系(PQS)...........................................................................9
4. 影响 GMP 检查实施的新 ICH 质量指导原则...............................11
5. 知识管理 ......................................................................................................12
6. 软件解决方案 ............................................................................................14
Q8910 Q&As(R4) .pdf
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