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纯化水系统验证方案2014910.doc

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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:.......................................................................................................77、运行确认:.........................................................................................................................118、性能确认:.........................................................................................................................179、偏差分析与整改:.............................................................................................................1910、结果分析与评价:...........................................................................................................1911、再验证:...........................................................................................................................1912、相关文件:................................................................

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