性能确认PQ(中英文).doc

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1、EXECUTIONAPPROVALSIGNATURES批准执行签名Thesignaturesbelowindicateapprovalofthisprotocolanditsattachmentsandindicatethatitisreadyforexecution.Anychangesormodificationstotheintentortheacceptancecriteriaofthisprotocol,followingapproval,requiresthegenerationofanamendmentwhic

2、hmustbeapprovedpriortoexecution.下面的签名表示批准本文件及其附件，且表明已经为执行作好了准备。在批准后，对本文件的目的或验收标准进行的任何改变或修正都必须起改善的作用，在执行以前就必须取得批准。Department&Site单位部门Signature&Date签名与日期Issuedby起草Reviewedby审核Authorizedby批准Contents目录1.0SCOPE范围32.0PURPOSE目的33.0BACKGROUND背景34.0INTRODUCTION介绍35.0REFEREN

3、CES参考书目46.0RESPONSIBLEPARTIESANDRESPONSIBILITIES责任方及其责任47.0SYSTEMDESCRIPTION系统说明6GeneralDescription总说明6PretreatmentUnit预处理单元6ReverseOsmosis(RO)System反渗透(RO)系统7MixedBedSystem混床系统8MonitorandControlSystem监视和控制系统98.0TESTINGPROCEDURES检验程序99.0ACCEPTANCECRITERIA验收标准10Atta

4、chment1-ValidationTestEquipmentandMaterials附件1–验证测试设备和材料11Attachment2–PWSystem30DaySamplingPlanDataSheet附件2–纯化水系统30天取样计划数据表12Attachment3–2ndPhasePWSystemSamplingPlanDataSheet附件3–纯化水系统第二阶段取样计划数据表15Attachment4-PWSampleTestResultForm附件4-PW样品测试结果表18Attachment5-Signatur

5、eVerificationList附件5-签名确认清单19Attachment6-ProtocolDeviationLog附件6-文件偏差日志20Attachment7-ProtocolDeviationRecord附件7-文件偏差记录21Attachment8-ProtocolExecutionApprovalSignaturesDataSheet附件8-文件执行批准签名数据表221.0SCOPE范围ThisPerformanceQualification(PQ)studywillbeperformedonthePurif

6、iedWater(PW)System,locatedinYUNGSHINPHARM.IND.(KS)CO.,LTD..Thescopeofthisprotocolwillbefortheinitial30daysofaggressivesampling.AnadditionalelevenmonthsofsamplingwillbeperformedperaYUNGSHINPHARM.IND.(KS)CO.,LTD.SOPtoestablishanentireyearofsampleresults.本性能确认（PQ）文件应用

7、于位于永信药品工业（昆山）有限公司的纯化水（PW）系统。本文件的范围将涵盖初始30天的取样。再附上11个月的取样情况，得到整一年的取样结果，取样方法标准为永信药品工业（昆山）有限公司SOP。Thisprotocoldescribestheequipment,testprocedures,specifications,documents,andreferencesusedtoestablishthatthePWSystemperformsinaccordancewiththemanufacturer’sdesignspecif

8、ications,andthoseofYUNGSHINPHARM.IND.(KS)CO.,LTD.本文件内容涉及设备、测试步骤、规格、文档和参考书目，这些是用来确保纯化水系统的性能符合生产商设计规范和永信药品工业（昆山）有限公司要求。ShanghaiBaojupersonnel,havep