洁净区设备清洁验证方案编号：bc-sop-qr-052-01题目：共9页第1页洁净区设备清洁验证方案洁净区清洁验证方案版次：□新订□替代：制定人：年月日审批会签：（验证小组）批准人：年月日生效日期：年月日编号：bc-sop-qr-052-01题目：共9页第2页洁净区设备清洁验证方案目录一、目的.....................................................................................................................................3二、范围.....................................................................................................................................3三、职责.......................................................................................................................................3四、参考依据................................................................................................................................4五、验证内容及方法.....................................................................................................................41、清洁方法验证原理...........................................................................................................42、生产设备描述.....................................................第1页共9页.............................................................53.清洁方法描述....................................................................................................................53.1设备清洁规程.............................................................................................................53.2清洁的常规要求.........................................................................................................54、清洗可接受标准的建立.....................................................................................................64.1残留量限度建立的原则...............................................................................................64.2可接受标准的确定........................................................................错误。未定义书签。5、取样方法及取样方案.........................................................................................................65.1取样方法....................................................................................................................65.2各设备的取样方案......................................................................................................76、相关方法及验证要求.........................................................................................................76.1表面化学残留的检验方第2页共9页法...........................................................................................76.2取样方法的回收率试验...............................................................................................87、清洁效果评价....................................................................................................................88、验证安排及验证进度.........................................................................................................88.1人员培训....................................................................................................................88.2验证实施....................................................................................................................88.3数据整理分析及报告.............................................................................................
