制药设备验证导则.pdf

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1、目录1.范围...............................................................................................................................................22.规范性引用文件.................................................................................................

2、..........................23.术语和定义...................................................................................................................................23.1制药机械（设备）验证.............................................................................

3、.......................23.2用户需求标准（URS）......................................................................................................23.3设计确认............................................................................................................

4、................23.4制药机械（设备）新产品设计确认................................................................................23.4安装确认(IQ)......................................................................................................................23.5运行确认(OQ

5、)....................................................................................................................23.6性能确认(PQ).....................................................................................................................23.7验证方案..

6、..........................................................................................................................33.8验证文件............................................................................................................................34

7、.验证...............................................................................................................................................34.1验证原则......................................................................................................

8、......................34.2验证目的............................................................................................................................34.3验证范围..............................................