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1、徐州金源臭氧设备有限公司新版GMP臭氧消毒灭菌验证方案编号：起草人:日期:年月日会审职务签字日期质量保证部经理质量检验部经理技术部经理工程部经理生产部生产总监批准职务签字日期质量受权人常务副总thetemplateisremoved,itshouldremovetemplatesbetweentheboltsandfittings,screwloosebracingsection,makingthetemplatebackandwalloff,verifythatiscorrect,beforeliftingthetemplate.Concrete
2、curingofconcretehasbeencompleted,shouldbecoveredandwaterconservation12h,castconcretewalls,columnscustomizationshouldbe第23页共23页徐州金源臭氧设备有限公司目录1.概述..............................................................32．验证目的.........................................................33.验证责任
3、.........................................................34．验证时间........................................................45．文件依据.........................................................56.培训.............................................................57.验证内容....................
4、.....................................67.1安装确认（IQ）...................................................67.1.1文件与资料确认.................................................67.1.2臭氧消毒系统设备性能参数确认...................................77.1.3测量仪表确认................................................
5、...87.2运行确认（OQ）...................................................87.2.1验证用检测仪表清单确认.........................................87.2.2臭氧浓度-时间分布确认..........................................97.3安装和运行确认结果汇总及结论....................................107.4性能确认（PQ）...........................
6、........................107.4.1微生物挑战性试验..............................................107.4.2异常情况处理程序……..........................................118.偏差.............................................................128.1偏差记录........................................................1
7、2thetemplateisremoved,itshouldremovetemplatesbetweentheboltsandfittings,screwloosebracingsection,makingthetemplatebackandwalloff,verifythatiscorrect,beforeliftingthetemplate.Concretecuringofconcretehasbeencompleted,shouldbecoveredandwaterconservation12h,castconcretewalls,colum
8、nscustomizationshouldbe第23页共23页徐州金源臭氧设备有限公司8.2偏差报告表..........
