纯化水OQ

运行确认方案OPERATIONALQUALIFICATIONPROTOCOL(OQP)纯化水机组PURIFIEDWATERSYSTEM江西汇仁药业有限公司运行确认方案OperationalQualificationProtocol4000L/HRO2纯化水机组方案批准ApprovalforProtocol编写Writtenby签名Signature日期Date审核Reviewedby签名Signature日期Date审核Reviewedby签名Signature日期Date审核Reviewedby签名Signature日期Date批准Approvedby签名Signature日期Date版本Edition颁布日期Issueddate颁布原因Reasonfornewissue运行确认方案OPERATIONALQUALIFICATIONPROTOCOL(OQP)纯化水机组PURIFIEDWATERSYSTEM客户名称：江西汇仁药业有限公司Customer:JiangxiHuirenPharmaceuticalCo.,Ltd.项目编号：2014089-03ProjectNo.文件编号:OQP-2014089-03-V1.0-YYDocumentNo.编辑日期：2014.07.25EditDate第1页共14页目录SUMMARY1目的PURPOSE......................................................................................................22范围SCOPE...........................................................................................................23职责RESPONSIBILITIES.......................................................................................24法规和指南REGULATIONANDGUIDANCE..........................................................25确认方法QUALIFICATIONSTRATEGY.................................................................26术语缩写GLOSSARYABBTEVIATED..................................................................37文件管理规范GOODDOCUMENTATIONPRACTICE...........................................38人员确认PERSONALIDENTIFICATION................................................................49.运行确认列表OQPROTOCOLACTIVITIES.........................................................510.运行确认内容OQACTIVITIESCONTENTS........................................................510.1先决条件PREREQUISITE.................................................................................610.2测试用仪器校准确认VERIFICATIONOFINSTRUMENTSCALIBRATION........710.3标准操作规程确认VERIFICATIONOFSOP......................................................810.4运行测试OPERATIONTESTS..........................................................................911.偏差报告DEVIATIONREPORT..........................................................................912OQ报告OQREPORT.......................................................................................27运行确认方案OPERATIONALQUALIFICATIONPROTOCOL(OQP)纯化水机组PURIFIEDWATERSYSTEM客户名称：江西汇仁药业有限公司Customer:JiangxiHuirenPharmaceuticalCo.,Ltd.项目编号：2014089-03ProjectNo.文件编号:OQP-2014089-03-V1.0-YYDocumentNo.编辑日期：2014.07.25EditDate第2页共27页1目的PURPOSE通过描述该纯化水系统的运行确认过程，来验证该系统能按设计运行，稳定可靠。TodescribetheprocedurefortheoperationalqualificationofthepurifiedwatersysteminordertoverifybydocumentsthatthePWsystemcanoperatestablyaccordingtothedesignedfunctions.2范围SCOPE该运行确认方案仅适用于下面的设备：Thisdocumentisonlyvalidforthenextproject:设备名称Projectdescription纯化水机组Purifiedwatersystem设备型号Projectmodel4000L/HRO2纯化水机组设备编号ProjectNo:2014089-03供应商Supplier山东潍坊精鹰医疗器械有限公司ShandongWeifangEagleMedicalAppliancesCo.,Ltd.3职责RESPONSIBILITIES质量部负责OQ方案的编写并对报告进行审核和批准。QualityDepartmentwriteOQP,reviewandapprovalOQreport.工程设备部负责OQ的执行并对报告进行审核。EngineeringDepartmentexecutesOQPandreviewandOQreport.4法规和指南REGULATIONANDGUIDANCE药品生产质量管理规范（2010年修订）GoodManufacturingPractices(2010revisededition)中华人民共和国药典2010版PharmacopoeiaofPeople’sRepublicofChina(2010edition)5确认方法QUALIFICATIONSTRATEGY通过文件来确认该纯化水系统满足所指定的功能，按此设计保证出水水质能满足要求。确保其每一阶段（设计、安装、运行及性能）满足要求。运行确认方案OPERATIONALQUALIFICATIONPROTOCOL(OQP)纯化水机组PURIFIEDWATERSYSTEM客户名称：江西汇仁药业有限公司Customer:JiangxiHuirenPharmaceuticalCo.,Ltd.项目编号：2014089-03ProjectNo.文件编号:OQP-2014089-03-V1.0-YYDocumentNo.编辑日期：2014.07.25EditDate第3页共27页Validationisdefinedasastudytobeabletoverifybydocumentsthatthepurifiedwatersystemfulfilstherolethathasbeenassigned,providingaqualityofwateraccordingtotherequirementswithaconsistentdesign,ensuringthateachphaseofthesystem(design,installation,operationandprocess)isinconformitywiththespecifications.每一确认阶段结束时都有确认报告详细说明被验证的每一项内容。每一阶段出现的问题都必须在报告中写出并提出正确的纠正措施、执行责任人及执行截止时间。Aqualificationpartialreportwillbeelaboratedattheendofeachqualificationphaseinwhichthecorrectdevelopmentofeachactivityshouldbeconfirmed.Incidencesfoundineachphasealsowillbepartofthereport,documentingthecorrectivemeasuresthathavebeentaken,responsibleforitsexecutionandthedeadlinetimefortheimplementation.只有当一个阶段完成后（发现的问题解决后或正确的纠正措施批准后）才可以开始下一阶段的工作。以保证确认的可靠性。Consideredthatonephaseiscompleted(andthuswillbeginthenextphase)onlyinthecasethatthedetectedincidenceshavebeencorrectedoracorrectiveactionplanhasbeenapprovedtoensurethesolidityofthequalification.6术语缩写GLOSSARYABBTEVIATED缩写ab.描述DescriptionPW纯化水DQ设计确认IQ安装确认OQ运行确认GMP药品生产质量管理规范RO反渗透7文件管理规范GOODDOCUMENTATIONPRACTICE记录用笔Recordingpens使用颜色不消退的墨水笔和记号笔记录。运行确认方案OPERATIONALQUALIFICATIONPROTOCOL(OQP)纯化水机组PURIFIEDWATERSYSTEM客户名称：江西汇仁药业有限公司Customer:JiangxiHuirenPharmaceuticalCo.,Ltd.项目编号：2014089-03ProjectNo.文件编号:OQP-2014089-03-V1.0-YYDocumentNo.编辑日期：2014.07.25EditDate第4页共27页Archiveproofinkpensormarkerpensshallbeused.签名Signature应签全名，除非文件另有规定。Unlessotherwisespecified,thefullnameshallbeusedasthesignature.签名应该是可辨认的Thesignatureshallbereadable.签名应始终一致Thesignaturesshallbeconsistent.填写栏目Columnfilling所有栏目必须填写Allthecolumnsshallbefilled.若有栏目不需要填入内容，则在空白处填写英文“不适用”的缩写“N/A”，以表示无此项内容。Ifthereisnothingtobefilledinonefield,suchfieldssha