VAP-OV-001_实验室器皿清洗效果验证方案.(03.03)

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1、ValidationProtocol验证方案VAPNumber：VAP-OV-001Version版本：00ValidationProtocolforCleaningMethodforApparatusinLaboratory实验室器具清洗方法验证方案EffectiveDate生效日期：Page10/10ValidationProtocolforCleaningMethodforApparatusinLaboratory实验室器具清洗方法验证方案DistributionQC分发质量控制部Writtenby：QC撰写人Departmen

2、t（部门）华晓维Xiaowei.HuaDate（日期）Reviewedby：QC复核人Department（部门）安永宏SimonAnDate（日期）Approvedby：QAValidation批准人Department（部门）郭玉林牛莉珣YulinLisaGuo.NiuDate（日期）Approvedby：QA批准人Department（部门）江焕朝HuanchaoJiangDate（日期）ValidationProtocol验证方案VAPNumber：VAP-OV-001Version版本：00ValidationProtoco

3、lforCleaningMethodforApparatusinLaboratory实验室器具清洗方法验证方案EffectiveDate生效日期：Page10/10TableofContent目录1.0Objective目的2.0Scope范围3.0Reference参考文件4.0Description描述5.0Responsibilities职责6.0Definition定义7.0StandardOperatingProcedure(SOP)andTrainingProofQualification标准操作规程和培训证明的确认8.0

4、Procedure程序8.1UseSystemconfigurationsandcleaningagents系统配置和相关清洁剂8.2CommonlyusedapparatuscleaningDifficultiesandeasyofanalysis常用器具清洗难易程度分析8.3Laboratorytestsample实验室目前日常检测样品8.4Pollutionmethod污染方法8.5CleaningMethod清洗方法8.6Testmethodsandresults检测方法和结果。8.6.1VisualTest目测8.6.2TO

5、CTestTOC测试8.6.3ConductivityTest电导率测试9.0Deviation偏差10.0Attachment附件RevisionHistory修订历史ValidationProtocol验证方案VAPNumber：VAP-OV-001Version版本：00ValidationProtocolforCleaningMethodforApparatusinLaboratory实验室器具清洗方法验证方案EffectiveDate生效日期：Page10/101.01.0Objective目的Thisvalidationp

6、rotocolintendstodemonstratethattheSOP-01-022/01inQCLabiscorrectandeffectiveinPuraCaplaboratory.通过对普克QC实验室的SOP-01-022/01《玻璃仪器的洗涤和干燥规程》草案进行验证，证明此方法正确、有效。2.0Scope范围ThisprotocolappliestoSOP-01-022/01

7、re>validationbyQCpersonalinPuracap.该方案适用于普克QC人员SOP-01-022/01《玻璃仪器的洗涤和干燥规程》草案的验证程序。3.0Reference参考文件USP现行版CurrentUSPSOP-01-022/01SOP-01-022/01《玻璃仪器的洗涤和干燥规程》草案TP-01-101/00TP-01-101/00《纯化水检测方法》4.0Description

8、描述The5affirmedglasswaresandsamplesinQCLabarepollutedbymethodunder8.3item.ThenwecleanthembySOP-01-022/01