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质量实施工作小组关于 Q8,Q9 和 Q10 的问与答(R4)
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
Q8_Q9_Q10_Question_and_Answer.pdf
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