Purified Water System Performance Qualification (PQ) Protocol纯化水系统性能确认（PQ）方案.doc

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1、PerformanceQualification(PQ)Protocol性能确认(PQ)方案EquipmentNO.设备编号：EU-SB-S-07NO.编号：PQP-EU-UT-002ProjectName项目名称ManufactureName制造商名称第94页共94页PerformanceQualification(PQ)Protocol性能确认(PQ)方案EquipmentNO.设备编号：EU-SB-S-07NO.编号：PQP-EU-UT-002Index目录1.Introduction介绍52.Purpose目的73.Scope范围83.1Scope

2、范围内83.2ExclusionofScope范围外94.Responsibilities职责94.1AustarResponsibilities奥星职责94.2HGPFResponsibilities哈药总厂职责95.Abbreviations缩略语116.RegulationandGuidance法规和指南137.References参考文件148.SystemDescription系统/设备描述198.1SystemUse系统用途198.2OperationandDesignFeatures运行和设计特点229.ValidationStrategy验

3、证策略259.1PerformanceQualificationFlow性能确认流程259.2PQsamplingplan性能确认取样计划2510.DocumentationControlSpecification文件管理规范3911.TestList测试项目列表43第94页共94页PerformanceQualification(PQ)Protocol性能确认(PQ)方案EquipmentNO.设备编号：EU-SB-S-07NO.编号：PQP-EU-UT-00212.PerformanceQualificationTests性能确认测试4512.1Pre

4、requisitesVerification先决条件确认4512.2PersonnelVerification人员确认4712.3SOPVerificationSOP确认4812.4TrainingVerification培训确认5112.5TestingInstrumentCalibrationVerification测试用仪器仪表校准确认5312.6SystemOperationParametersVerification系统运行参数确认5512.7SanitizationVerification消毒确认5612.8TheWaterqualityfor

5、pre-treatmentSystemVerification预处理水质认5912.9PWQualityVerification纯化水质量确认6113.DeviationHandling偏差处理6614.ChangeHandling变更处理6615.SummaryofPQ性能确认总结6616.ListofAttachment测试报告附件68TestReport1测试报告170TestReport2测试报告274TestReport3测试报告376TestReport4测试报告479TestReport5测试报告581TestReport6测试报告683第9

6、4页共94页PerformanceQualification(PQ)Protocol性能确认(PQ)方案EquipmentNO.设备编号：EU-SB-S-07NO.编号：PQP-EU-UT-002TestReport7测试报告786TestReport8测试报告888TestReport9测试报告991第94页共94页PerformanceQualification(PQ)Protocol性能确认(PQ)方案EquipmentNO.设备编号：EU-SB-S-07NO.编号：PQP-EU-UT-002Introduction介绍HarbinPharmaceu

7、ticalGroupGeneralPharmaceuticalFactory(hereinaftercalledHGPF)isestablishinganewproductionbuildinginaccordancewiththeChineseGMPandEUGMPrequirements.ShanghaiAustarisresponsiblefordetaileddesignandconstructionofnewPurifiedWaterGenerationStorageandDistributionSysteminthisplant,anditis

8、usedforprovidingwaterforproductio