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纯化水系统验证方案2014.9.10.docx

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天方药业有限公司纯化水系统验证方案VOP-2014040330目录一、目的:.......................................................................................................................................2二、适用范围:...............................................................................................................................2三、职责:.......................................................................................................................................2四、内容:.......................................................................................................................................21、概述与风险评估:.............................................................................................................22、验证小组成员:.................................................................................................................33、验证指导与参考文献:.....................................................................................................44、验证人员培训及健康状况:.............................................................................................45、对纯化水分配系统进行设计确认:.................................................................................46、纯化水系统安装确认:.....................................................................................................97、运行确认:.......................................................................................................................138、性能确认:.......................................................................................................................209、偏差分析与整改:...........................................................................................................2210、结果分析与评价:.........................................................................................................2211、再验证:.........................................................................................................................2212、相关文件:....................................................................................................

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