新版GMP验证文件(2010修订版)—空调净化验证方案(2012).doc

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1、.word格式.xxxxxx车间空调净化系统验证方案系统编号：xxxxxxxx验证类型：公用设施验证方案制定部门签名日期工程设备部方案审核部门签名日期工程设备部生产技术部质量部方案批准质量部经理签名批准日期.专业资料.学习参考..word格式.分发部门:工程设备部、质量部、生产技术部、xxxxxx车间xxxxxx目录1.概述..........................................................................................

2、................................................32.验证目的..................................................................................................................................33.验证范围.............................................................

3、.....................................................................34.验证小组成员及职责..............................................................................................................35.验证方案的起草、审批及培训..............................................

4、...............................................45.1验证方案的起草及审批......................................................................................................45.2验证方案的培训...............................................................................

5、..................................46.进度计划.................................................................................................................................47.验证..............................................................................

6、............................................................47.1预确认.................................................................................................................................47.2安装确认.................................................

7、............................................................................87.3运行确认.............................................................................................................................137.4性能确认...................................

8、..........................................................................................158偏差与异常情况处理............................................................................................................219变更与再验证周期........