工程验证和相关文件清单

工程验证及相关文件目录验证主计划目录（VMP）1INTRODUCTION序言2REFERENCES参考2.1GMPRulesandguidelinesGMP法规和指南2.2Designdocuments设计文件3FACILITYOVERVIEW厂房概要3.1ProductionAreas生产区3.2R&DandQCLaboratories研发和QC实验室3.3Warehouse仓库4XXXXMANUFACTURINGPROCESSDESCRIPTIONXXX生产工艺描述5AreasClassification区域分类5.1CleanlinessAreaClassification洁净区分类5.2HVACSystems空调系统5.2.1XXXXProductionAreasXXXX生产区6PersonnelandmaterialFlow人流和物流6.1Personnelflow人流6.2MaterialFlow物流7PressureLayOut压力分布图8UTILITIES公用设施8.1ProcessUtilities工艺用公用设施8.1.1PurifiedWater纯水8.1.2Processair工艺用空气8.1.3PureNitrogen纯氮8.2TECHNICALUTILITIES技术用公用设施8.2.1POTABLEWATER(W)SYSTEM饮用水系统8.2.2HOTWATERFORHVAC(HWS)空调用热水系统8.2.3HOTSANITARYWATER(HSWS)卫生型热水8.2.4MEDIUMANDLOWPRESSURESTEAM中压和低压蒸汽8.2.5COMPRESSEDAIR压缩空气8.2.6CHILLEDWATER冷冻水8.3SUPPORTSYSTEMS配套系统8.3.1PROCESSSEWER工艺废水8.3.2EQUALISATION/NEUTRALISATIONSYSTEM中和系统8.3.3GASEOUSEFFLUENTSHANDLING气体处理系统8.3.4FIREWATERSYSTEM消防系统8.3.5FOAMSYSTEM消防泡沫系统8.3.6DRYCHEMICALSYSTEM干粉系统8.3.7CARBONDIOXIDESYSTEM二氧化炭系统8.3.8FIRE-FIGHTINGSYSTEMSELECTION火灾报警系统9CRITICALPROCESSSTEPSandCRITICALEQUIPMENT关键的工艺步骤和关键设备10VALIDATIONAPPROACH验证方法10.1GMPReviewGMP审核10.2DesignQualification设计确认10.3FactoryAcceptanceTest工厂验收测试10.4Mechanicalcompletion机械性完工10.5Calibration校准10.6Commissioning调试10.7SiteAcceptanceTest现场验收测试10.8ValidationTurnoverpackage(Vtop)验证文件包10.9InstallationQualification安装确认10.9.1IQAcceptanceCriteria可接受标准10.10ComputerInstallationQualification计算机系统的安装确认10.10.1CIQacceptancecriteria可接受标准10.11OperationalQualification运行确认10.11.1OQAcceptanceCriteria运行确认的可接受标准10.12ComputerOperationalQualification计算机运行确认10.12.1COQacceptancecriteria可接受标准10.13PerformanceQualification(PQ)性能确认10.13.1PQAcceptanceCriteria可接受标准10.14ProcessValidation工艺验证10.14.1ProcessValidation工艺验证10.14.2ProcessValidationAcceptancecriteria工艺验证可接受标准10.15CleaningValidation清洗验证10.15.1CleaningValidation清洗验证10.15.2CleaningValidationAcceptancecriteria清洗验证的可接受标准10.16SpecificacceptancecriteriaforQualification确认工作的特定的可接受标准10.16.1HVAC,LAFandArchitectureRoomFinishing空调系统、层流装置和房间的装饰10.16.2PurifiedWaterProduction,StorageandDistribution纯化水生产、存储和分配系统10.16.3CompressedAir压缩空气10.16.4Nitrogen氮气10.16.5Scales称量装置10.16.6XXXMelterandFillingsolutionPreparationTankXXX罐和内容物溶液配制罐10.16.7Rawmaterial,XXXXandFillingsolutionHoldingTanks原料、XXXX和内容物溶液保存罐10.16.8XXXXBaseturbomixerXXXX着色器10.16.9XXXmachineXX机10.16.10TumbleDryer转筒式干燥机10.16.11DryingTunnel干燥隧道10.16.12Sortingmachine拣丸机10.16.13XXXXsWashingmachine(Future)洗丸机10.16.14XXXXprintingmachine(Future)XXXX打字机10.16.15Opticalinspectionmachine目检机10.16.16Blisteringmachine铝塑包装机10.16.17BottleFillingmachine装瓶机10.16.18Cappingmachine封盖机10.16.19Labelingmachine贴标机10.16.20Boxingmachines装盒机10.16.21Cartoningmachine装箱机11COMMISSIONING&VALIDATIONMATRIX调试和验证矩阵12COMMISSIONING&VALIDATIONTIMESCHEDULE验证时间进度表13LISTOFSOP'S标准操作程序清单14QUALIFICATION/VALIDATIONMETHODOLOGY验证方法14.1ProtocolGeneration方案的形成14.2ProtocolApproval方案的批准14.3ProtocolExecution方案的执行14.4ReviewofExecution&RawData执行和原始数据的审核14.5FinalSummaryReportGeneration最终总结性报告的形成14.6ChangeControl变更控制15RESPONSIBILITY职责15.1GeneralManager技术总监15.2QualityAssurance/Control经理15.3QualityControl质量控制15.4ProjectManager项目经理15.5ProductionManager生产经理15.6Contractors合同商16SUPPORTSERVICES支持性服务16.1Training培训16.2Preventivemaintenance预防性维护保养16.3Calibration校准17RE-QUALIFICATION/VALIDATIONSCHEDULE重新验证时间安排18LISTOFATTACHMENTS附件清单水系统验证报告文件清单WaterSystem设计确认DQ1.目的Purpose2.职责Responsibility3.设计参考文件清单ReferenceDocumentList4.设备描述SystemDescription5.设计确认描述和可接受标准DesignDescription&AcceptanceCtiteria5.1先决条件Prerequisites5.2设计文件确认DesignDocumentVerification5.3安全确认SafetyVerification5.4系统温度的确认TemperatureVerification5.5系统流速和生产能力的确认Velocity&CapacityVerification5.6仪表确认InstrumentVerification5.7材料和物体表面的检查Material&SurfacefininshingVerification5.8润滑剂的确认LubricantVerification5.9排水能力的确认DrainablityVerification5.10系统设备、管道、联结件结构的确认MainCompoment,Piping&JointerVerification5.11控制系统的确认ControlSystemVerification5.12系统安装焊接工作要求的确认WeldingVerification5.13系统清洗和钝化的确认PicklingandPassivationVerification5.14系统在线灭菌能力的确认SIPVerification6.人员的鉴别PersonnelIdentification7.偏差报告DeviationReport8.注释Comment9.偏差清单DeviationList10.附件清单AttachmentList11.回顾和批准Review&Approval12.改造和更改控制ChangeControl13.设计确认报告目录IndexofReportIQINDEX目录1.PURPOSE目的2.RESPONSIBILITY职责3.LISTOFREFERENCEDOCUMENT参考文件清单4.EQUIPMENTDESCRIPTION设备描述5.GENERALMETHODLOGY通用方法：6TESTDESCRIPTIONANDACCEPTANCECRITERIA测试描述和可接受标准6.1Prerequisites先决条件6.2DocumentsVerification文件确认6.3SafetyVerification安全确认6.4P&IDandLayoutDrawingCheckP&ID和布局图的检查6.5EquipmentListCheck设备清单检查6.6InstrumentsListandInstrumentCalibrationVerification仪表清单和仪表校准的核实6.7MaterialsandSurfaceFinishesCheck材料和物体表面的检查6.8LubricantVerification润滑剂的确认6.9DrainabilityVerification排水能力的确认6.10UtilitiesVerification公用设施的确认6.11ControlSystemElectricalCabinet&WireDiagramCheck控制系统、电气柜和接线图的检查6.12SoftwareVerification软件的确认6.13PicklingandPassivationverification酸洗和钝化的检查6.14WeldingCheck焊接质量的检查7PERSONNALIDENTIFICATION人员的鉴别8DEVIATIONREPORT偏差报告9COMMENTSECTION注释10LISTOFDEVIATION偏差清单11LISTOFATTACHMENT附件清单12EXECUTIONREVIEWANDAPPROVAL回顾和批准13MODIFICATION&CHANGECONTROL改造和更改控制14INDEXOFTESTREPORT测试报告目录OQ目录1.PURPOS