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首页 (49)纯化水系统操作确认验证方案OQ006-004

(49)纯化水系统操作确认验证方案OQ006-004.doc

(49)纯化水系统操作确认验证方案OQ006-004

zhangqingkun198211
2018-09-08 0人阅读 举报 0 0 0 暂无简介

简介:本文档为《(49)纯化水系统操作确认验证方案OQ006-004doc》,可适用于医药卫生领域

RGP版本Release:页码Page:纯化水系统操作确认验证方案pureWaterSYSTEMOperationalQualificationProtocol编号ID:OQ修订记录Revisionhistory:版:初始版本ReleaseInitialRelease部门Function姓名Name签名Signature日期Date制定人Author验证代表Validationrepresentative审核人Reviewers维修保养部门代表Maintenancerepresentative批准人ApproverforEnglishversionQA经理QAmanager批准人Approverforbilingualversion管理者代表Managementrepresentative目的Purpose此文件的目的是为了建立书面上的依据表明纯水的产生储存管道的运行都是根据供应商的规格来操作并且能够根据用户需求生产储存和提供纯水。ThepurposeofthepresentOperationalQualificationProtocolistoestablishdocumentaryevidencethatPurifiedWaterSystem(Generation,StorageandDistribution)worksinaccordancewithoperationsupplierspecifications,anditisabletoproduce,storeandprovidewateraccordingtouserrequirements本文件检查水系统的自动化系统警报和回路中水的流速Thisprotocolwillchecktheautomatismandsystem'salarmsaswellasthepressureregulationofthewaterthroughtheloop认证策略STRATEGYOFTHEQUALIFICATION由有资质的技术人员进行认证包括几个测试的执行以此来验证安装是否合格。QualifiedtechnicalpersonnelwillcarryouttheverificationItwillconsistintheexecutionofseveralteststhatwillallowtheverificationthattheinstallationworksinaccordancewithitspurpose系统包括几个测试来验证安装的功能也包括一些不利情况或“最坏情况”测试来验证系统在紧张情况下的坚固性。Thesystemwillbesubjectedtoseveraltestsinordertoverifythefunctionalityoftheinstallation,anditwillbealsosubjectedtounfavorablesituationsor“worstcase”testsinordertoverifythesystem’srobustnessinfrontofstresssituations参考法规与文件Documentreferences文件编号ReferenceNo文件标题TitleURS药业厂房要求UserrequirementspecificationforJVbuildingSBEGPR验证主程序GeneralProcedureforvalidation职责RESPONSIBILITIES步骤Steps部门Department执行测试TestExecution技术代表和供应商Technicalrepresentativeandsupplier测试结果审核TestVerification验证部门代表Validationrepresentative验证报告撰写Writingthereport验证部门代表Validationrepresentative定义与缩写Definitionsandabbreviation缩写Shortform定义DefinitionPWPurifiedwaterROReverseosmosisEDIElectrodeionization系统简介Systemdescription见安装确认方案SeeIQprotocol验证方案设计理由qualificationstrategy进行操作验证测试来确认主要参数及合格标准Theoperationqualificationtestswillcarryouttoverifythecriticalparameterandacceptancecriteria重要参数Criticalparameter合格标准Acceptancestandards物理化学参数Physicalandchemicalparameters电导率(℃时)conductivity:μScm(℃)pH:HeavyMetals<Nitrates<微生物分析Microbiology总需求性生物量totalamountCFUml操作参数Operationparameters回程速度Returningspeed最小minimun:≥m/s纯水储罐和管道臭氧消毒浓度≥PPM验证测试QuAlificationTestS测试方案编号References测试名称DescriptionOQTest自动运行验证AutomatismqualificationOQTest操作参数证明QualificationofoperationalparametersOQTest产水储备分配的验证Qualificationforproductwater,storage,anddistribution合格标准Acceptancecriteria验证通过的条件:Operationalqualificationisacceptedif:执行所有的验证内容没有不可接受的偏差测试获得通过呈交的报告须是书面的并获得批准Allactivitieshavebeenperformed,Noblockinganomalyremains,Thereportiswrittenandapproved只有在顺利地执行安装确认并获得通过后才能开始进行操作确认OQcanonlystartiftheIQhasbeenperformedwithoutblockinganomaly前提Prerequisite完成Check安装确认的报告已通过TheIQreporthasbeenacceptedFORMCHECKBOX本方案已签署ThisprotocolisacceptedFORMCHECKBOX操作人员经过执行验证的训练OperatorsaretrainedforprocessvalidationexecutionFORMCHECKBOX目标OBJECTIVE验证指示器自动设备警报控制器具的正确性Verifythecorrectoperationofindicators,automatism's,alarmsandcontrolelementsoftheinstallation方法METHODOLOGY完成一个表格其中包括详细的安装过程中制造警报的列表和预计效果检查警报系统是否安装正确并且能够正确报警。TheverificationmatrixwillbecompletedwithadetailedalarmlisttobeperformedintheinstallationandtheexpectedeffectVerifythatthealarmsaretheexpectedonesandtheinstallationoperatescorrectly验收标准ACCEPTANCECRITERIA每一个警报系统和用户技术要求相符Eachofthealarmstriedperformtheexpectedeffects,inaccordancewithsupplierspecifications自动功能的验证Autorunverification警报系统Warmingsystem测量器具Measuringtool设定点Settingpoint动作action结果Result(CNC)原水箱液位传感器Lowliquidlevelofrawwatertank液位传感器LTliquidlevelswitchLL当原水箱内水量小于等于L时系统自动停止原水泵原水泵指示灯熄灭原水箱水量从L增加到L的过程中原水泵维持在停止状态。当原水箱内水量大于等于L时系统自动启动原水泵原水泵指示灯亮原水箱水量从L减少到L的过程中原水泵维持在运行状态。LL当原水箱内水量小于等于L时系统自动启动原水进水角座阀原水箱水量从L增加到L的过程中原水进水角座阀维持在运行状态。当原水箱内水量等于L时系统自动停止原水进水角座阀原水箱水量从L减少到L的过程中原水进水角座阀维持在停止状态。高压泵进口压力Highpressurepumpinlet压力开关PSPressureswitchbarbar高压泵接到启动命令后在原水泵运行的情况下压力开关PS达到bar并维持秒以上高压泵启动当压力开关PS小于等于bar时高压泵停止高压泵指示灯熄灭当压力开关PS从新达到bar并维持秒以上高压泵再次启动。Highpressurepumpreceivestheorderofstart,iftherawwaterpumpisinthestatusofrunning,pressureswitchPT≤reachesbarandsustainformorethans,highpressurepumpstartedwhenpressureswitchRO水箱液位传感器LowliquidlevelofROwatertank液位传感器LTliquidlevelswitchLL当RO水箱内水量小于等于L时系统自动停止中间水泵中间水泵指示灯熄灭RO水箱水量从L增加到L的过程中中间水泵维持在停止状态。当RO水箱内水量大于等于L时系统自动启动中间水泵中间水泵指示灯亮RO水箱水量从L减少到L的过程中中间水泵维持在运行状态。Whentheliquidlevel≤L,stopautomatically,theindicatorofhighpressurepumpdisappearLL当RO水箱内水量小于等于L时系统自动启动原水泵、高压泵原水泵、高压泵指示灯亮RO水箱水量从L增加到L的过程中原水泵、高压泵维持在运行状态。当RO水箱内水量等于L时系统自动停止原水泵、高压泵原水泵、高压泵指示灯熄灭RO水箱水量从L减少到L的过程中原水泵、高压泵维持在停止状态。EDI纯水出水流量EDIpurewaterflow流量计FTFlowmeterLh当EDI纯水流量计FT流量小于等于Lh时EDI电源停止工作EDI电源指示灯熄灭当EDI纯水流量计FT流量大于Lh时EDI电源启动EDI电源指示灯亮。EDI浓水进水流量EDIwastewaterflow流量计FTFlowmeterFTLh当EDI浓水流量计FT流量小于等于Lh时EDI电源停止工作EDI电源指示灯熄灭当EDI浓水流量计FT流量大于Lh时EDI电源启动EDI电源指示灯亮。EDI纯水电导率EDIpurewaterconductivity电导率表CTConductivitymeterμscmμscm当EDI电导率表CT电导率小于μscm纯水箱进水阀KDV开启EDI产水进入纯水箱在纯水电导率从μscm到μscm过程中纯水箱进水阀维持在电导率小于μscm时的状态纯水当EDI电导率表CT电导率大于μscm纯水箱进水阀KDV关闭中间水箱回水阀KDV开启EDI产水回流到中间水箱在纯水电导率从μscm到μscm过程中中间水箱回水阀维持在电导率大于μscm时的状态。纯水箱液位传感器Lowliquidlevelofpurewatertank液位传感器LTLiquidlevelswitchLL当纯水箱内水量小于等于L时系统自动停止纯水泵纯水泵指示灯熄灭纯水箱水量从L增加到L的过程中纯水泵维持在停止状态。当纯水箱内水量大于等于L时系统自动启动纯水泵纯水泵指示灯亮纯水箱水量从L减少到L的过程中纯水泵维持在运行状态。LL当纯水箱内水量小于升时EDI隔膜阀出水口转换到纯水箱进水管上EDI产水进入纯水箱纯水箱水量从L增加到L的过程中隔膜阀维持在纯水箱内水量小于L时的状态。当纯水箱内水量大于升时EDI隔膜阀出水口转换到RO水箱回水管上EDI产水回流到RO水箱纯水箱水量从L减少到L的过程中隔膜阀维持在纯水箱内水量大于L时的状态。步骤No测试步骤Stepdescription通过标准Acceptancecriteria试验结果Observedresults合格与否CNC偏差报告编号Anomalyreference自动功能的验证Autorunverification见上表Seetableabove见上表Seetableabove步骤No备注Comments测试操作人Testperformedby:签名Signature日期Date测试所用计量仪器Listofequipmentsused:附件列表Listofattachments测试审核人Testreviewedby:签名Signature日期Date合格Conform(不合格Nonconform(备注Comments:前提Prerequisite完成CheckNAFORMCHECKBOX目标验证确切的臭氧浓度和系统回路流量。OBJECTIVEVerifythespecifiedtemperaturecontrolanddistributionsystempressure方法完成验证表格METHODOLOGYCompleteVerificationMatrix验收标准确认纯水系统的主要操作参数和使用规格和中国药典(版)关于纯水系统储存和分配的建议相符合ACCEPTANCECRITERIAVerifythatthePWsystemcriticaloperationalparameterscomplywiththeuserspecificationforPWandwiththeChinesePharmacopea()recommendationsforwatersystemsstorageanddistribution重要操作参数的验证Qualificationofcriticaloperationparameter参数parameter操作范围operationscale器具devices结果result回流流速Returning≥mSyesno纯水储备罐分配管道杀菌臭氧浓度temperatureofPWfordisinfection≥PPMyesno步骤No测试步骤Stepdescription通过标准Acceptancecriteria试验结果Observedresults合格与否CNC偏差报告编号Anomalyreference重要操作参数的验证(见上)Qualificationofcriticaloperationparameter(seeabove)见上表Seetableabove见上表Seetableabove步骤No备注Comments测试操作人Testperformedby:签名Signature日期Date测试所用计量仪器Listofequipmentsused:附件列表Listofattachments测试审核人Testreviewedby:签名Signature日期Date合格Conform(不合格Nonconform(备注Comments:前提Prerequisite完成CheckNAFORMCHECKBOX目标OBJECTIVE检查水质包括生产水储存的水和分配的水是否符合参数要求方法Tochecktheanalyticalqualityofproduced,storedanddistributedwaterandverifythatitcomplieswithspecifications客户质量控制部门在取样阀和用水点对水质进行周的取样测试:Qualitycontroldepartmentmustcarryoutanalyticalsamplingfollowingthisplan常规Generalrules在三周(个开启日)时间内每个点(取样点和使用点):Forthreeweeks(opendays),foreachpoint(SamplingpointandUserpoints):最重要的点每天都必须进行测试Mostcriticalpointsmustbetestedeachday,相对不太重要的点在整个监测过程中至少检测次Lesscriticalatleasttimesduringthisperiod,出水点的危险性分析Determinationofthecriticalityofthepoints用于溶液配制的使用点都认为是重要的Pointsusedforsolutionpreparationareconsideredascritical用水点Point位置Location用途UseCriticality(YN)PW清洗RinsingNPW超声波洗瓶机UltrasonicbathNPW清洗RinsingNPW玻璃仪器清洗机DishwasherNPW洗衣机ClotheswasherNPW水槽BasinNPW孵箱IncubatorsNPW冻干机FreezedryerNPW配制BulkingYPW洁净工具间CleaningtoolsroomNPW取样点PW取样点PW取样点需要检测的参数Parameterstobechecked参数Parameters合格标准AcceptancecriteriapH菌落数CFU(CFUml电导率Conductivity(µscmCl根据中国药典版方法检测无沉淀NoprecipitateaccordingtomethodreferredinChinesePharmacopeaSo根据中国药典版方法检测无沉淀NoprecipitateaccordingtomethodreferredinChinesePharmacopeaCa根据中国药典版方法检测无沉淀NoprecipitateaccordingtomethodreferredinChinesePharmacopeaCO根据中国药典版方法检测无沉淀NoprecipitateaccordingtomethodreferredinChinesePharmacopeaNH(NO(NO(氧化物OxidableMatter根据中国药典版方法检测无沉淀NoprecipitateaccordingtomethodreferredinChinesePharmacopea不挥发物NonvolatileMatter<mgml重金属HeavyMetals(验收标准水质符合中国药典对于纯水的参数要求AcceptancecriteriaWatercomplieswithChinesePharmacopoeia(version)specificationsforPW步骤No测试步骤Stepdescription通过标准Acceptancecriteria试验结果Observedresults合格与否CNC偏差报告编号Anomalyreference纯水质量验证QualificationforPWquality(seebelow)见下表Seetablebelow见下表Seetablebelow纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWPWNANANANANANANANANANANANANAPWPWPWDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWPWNANANANANANANANANANANANANAPWPWPWDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWNANANANANANANANANANANANANAPWPWPW纯水质量验证QualificationforPWqualityDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWPWNANANANANANANANANANANANANAPWPWPWDAYWEEK日期Date:参数ParameterspH菌落数CFU电导率ConductivityClSoCaCONHNONO氧化物OxidableMatters不挥发物NonvolatileMatters重金属HeavyMetals合格标准Acceptancecriteria(ml(µscm无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate无沉淀Noprecipitate(((无沉淀Noprecipitate<mgml(PWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWNANANANANANANANANANANANANAPWPWPWPWPW步骤No备注Comments测试操作人Testperformedby:签名Signature日期Date测试所用计量仪器Listofequipmentsused:附件列表Listofattachments测试审核人Testreviewedby:签名Signature日期Date合格Conform(不合格Nonconform(备注Comments:验证方案设计理由qualificationstrategy进行操作验证测试来确认主要参数及合格标准TheoperationqualificationtestswillcarryouttoverifythecriticalparameterandacceptancecriteriaRGP验证方案QUALIFATIONPROTOCOL

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