toc验证方案和报告

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1、WWW.HIGMP.COMGMP爱好者EXECUTIONAPPROVALSIGNATURES批准执行签名Thesignaturesbelowindicateapprovalofthisprotocolanditsattachmentsandindicatethatitisreadyforexecution.Anychangesormodificationstotheintentortheacceptancecriteriaofthisprotocol,followingapproval,requiresthegenerationofan

2、amendmentwhichmustbeapprovedpriortoexecution.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。***CompanyLTD:Date***:Date***:Date1.0SCOPE:范围42.0PURPOSE:范围4WWW.HIGMP.COMGMP爱好者3.0BACKGROUND:背景44.0INTRODUCTION:介绍45.0REFERENCES:参考书目56.0RESPONSI

3、BLEPARTIESANDRESPONSIBILITIES:责任方及其责任77.0SYSTEMDESCRIPTION:系统说明98.0TESTINGPROCEDURES:测试程序109.0ACCEPTANCECRITERIA:验收标准:11Attachment1-ValidationTestEquipmentandMaterials附件1—确认测试设备和材料13Attachment2-SpecificationandPurchaseOrderVerification附件2—规范和采购单确认14Attachment3-Engineerin

4、gDrawingList附件3—工程图纸清单15Attachment4-StandardOperatingProceduresList附件4—标准操作程序清单16Attachment5-PreventiveMaintenance附件5—预防性维护17Attachment6-OperationandMaintenanceManualList附件6—操作和维护手册清单18Attachment7-MajorComponentLabelingList附件7—主要部件标签清单19Attachment8-CriticalInstrumentList

5、附件8—关键仪器清单20Attachment9-Non-CriticalInstrumentList附件9—非关键仪器清单21Attachment10-SparePartsList附件10—备件清单22Attachment11-UtilityDataSheet:Electrical附件11—公用工程数据表：电23Attachment12-UtilityDataSheet:CompressedAir附件12—公用工程数据表：压缩空气20Attachment13-OperationalTesting,TOCAnalyzer附件13—操作测试

6、，TOC分析器241Attachment14-ROMandConfigurationTest附件14—ROM和构造测试262Attachment15-MechanicalCheckTest附件15—机械检查测试29Attachment16-FlowTest附件16—流量测试31Attachment17-Linearity/SampleMeasurementTest附件17—线性/样品测量测试33Attachment18-OperationalTesting,TOCAutoSampler附件18—操作测试，TOC自动取样30Attachm

7、ent19-MechanicalTest附件19—机械测试41Attachment20-SampleTest附件20—样品测试43Attachment21-SpargeTest附件21—喷射测试44Attachment22-MagneticStirrerTest附件22—磁力搅拌器测试45Attachment23-SignatureVerificationList附件23—签名确认清单36Attachment24-ProtocolDeviationLog附件24—文件偏差日志37Attachment25-ProtocolDeviatio

8、nRecord附件25—文件偏差记录38Attachment26-ProtocolExecutionApprovalSignatureDataSheet附件26—文件执行批准签名数据表39WWW.HIGMP