纯化水PQ

公司标志性能确认方案PERFORMANCEQUALIFICATIONPROTOCOL(PQP)纯化水机组PURIFIEDWATERSYSTEM江西汇仁药业有限公司性能确认方案PerformanceQualificationProtocol4000L/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公司标志性能确认方案PERFORMANCEQUALIFICATIONPROTOCOL(PQP)纯化水机组PURIFIEDWATERSYSTEM文件编号：PQP-DocumentNo.编辑日期：EditDate目录SUMMARY1目的PURPOSE........................................................................................................-3-2范围SCOPE.............................................................................................................-3-3职责RESPONSIBILITIES.........................................................................................-3-4法规和指南REGULATIONANDGUIDANCE............................................................-3-5确认方法QUALIFICATIONSTRATEGY...................................................................-3-6术语缩写GLOSSARYABBTEVIATED....................................................................-4-7文件管理规范GOODDOCUMENTATIONPRACTICE.............................................-4-8性能确认执行的三个阶段PQTHREEPHASES........................................................-5-9性能确认内容PQACTIVITIES..................................................................................-6-9.1先决条件PREREQUISITE.....................................................................................-6-9.2验证仪器校准确认VERIFICATIONOFINSTRUMENTSCALIBRATION...............-6-9.3标准操作规程确认VERIFICATIONOFSOP..........................................................-7-9.4第一阶段：密集取样测试PHASE1.......................................................................-8-9.5第二阶段：密集取样测试PHASE2.....................................................................-10-9.6第三阶段：常规取样测试PHASE3.....................................................................-10-9.7人员的确认PERSONALIDENTIFICATION.........................................................-11-10偏差报告DEVIATIONREPORT...........................................................................-12-11偏差清单DEVIATIONLIST...................................................................................-12-12附件清单ANNEXLIST........................................................................................-12-13性能确认报告PQREPORT..................................................................................-12-14变更控制CHANGECONTROL.............................................................................-12-15PQ表目录DQtablesummary..............................................................................-13-PQ-1先决条件确认Prerequisitesverification............................................................-14-PQ-2验证仪器校准确认Instrumentcalibrationverification........................................-15-PQ-3标准操作规程确认SOPverification..................................................................-16-PQ-4第一阶段取样测试报告Testrecordforphase1................................................-17-公司标志性能确认方案PERFORMANCEQUALIFICATIONPROTOCOL(PQP)纯化水机组PURIFIEDWATERSYSTEM文件编号：PQP-DocumentNo.编辑日期：EditDate-2-PQ-5第二阶段取样测试报告Testrecordforphase2................................................-21-PQ-6第三阶段取样测试报告Testrecordforphase3................................................-25-PQ-7人员确认Personalidentification.......................................................................-29-PQ-8偏差报告Deviationreport.................................................................................-30-PQ-9偏差清单Deviationlist......................................................................................-31-PQ-10附件清单Attachmentlist.................................................................................-32-PQ-11性能确认报告PerformanceofQualification(PQ)report...................................-33-公司标志性能确认方案PERFORMANCEQUALIFICATIONPROTOCOL(PQP)纯化水机组PURIFIEDWATERSYSTEM文件编号：PQP-DocumentNo.编辑日期：EditDate-3-1目的PURPOSE通过描述该纯化水系统的性能确认过程，来验证该系统的水质是否符合《中国药典》2010版纯化水标准。TodescribetheprocedurefortheperformancequalificationofthepurifiedwatersysteminordertoverifybydocumentsthattheproducedwatercompliesCP2010.2范围SCOPE该性能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PQ的执行。QualityDepartmentexecutePQ.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。Validationisdefinedasastudytobeabletoverifybydocumentsthatthepurifiedwatersystemfulfilstherolethathasbeenassigned,providingaqualityofwateraccordingtotherequirementswithaconsistentdesign,ensuringthateachphaseofthesystem(design,installation,operationandprocess)isinconformitywiththespecifications.公司标志性能确认方案PERFORMANCEQUALIFICATIONPROTOCOL(PQP)纯化水机组PURIFIEDWATERSYSTEM文件编号：PQP-DocumentNo.