确保通过审核的步骤FAQ

本FAQ文件是网络研讨会的后续追踪,“确保通过审核的步骤:有效风险评估设计”。关于洁净室的设计、制药过程中的粒子和微生物控制以及风险评估方法,提出了许多值得思考的问题。在网络研讨会期间和之后提交的问题如下所示。

问题分类:
• 监测要求
• 悬浮粒子监测
• 方法验证
• 审核&风险评估
• 清洁和卫生处理
• 应用

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