中美天津史克工厂验证主计划

GlaxoSmithKlineTSK&FTitle:题目SiteValidationMasterPlanofTSK&F中美天津史克工厂验证主计划DocumentNo文件编号DocumentType文件类型PageNumber页码SVMP_16SiteValidationMasterPlan1of49ApprovalandAuthorization批准和授权Completionofthefollowingsignatureblockssignifiesthereviewandapprovalofthisdocument完成以下签字意味着完成了对此文件的回顾和批准Name姓名JobTitle/Role职位/角色Signature签字Date日期TheAuthorissigningtoconfirmthatthisdocumenthasbeenpreparedinaccordancewithanapproveddocumentmanagementprocessthatcontentisconsistentwiththedeliverabledefinitionfoundinthePSOP1432SiteValidationApproach,andthatrelevantinputfromanycontributoryauthorshasbeenincluded.作者的签字证明文件是按照批准的文件管理规程准备的，其中内容符合PSOP1432工厂验证流程对验证文件的定义。并确认相关人员的意见均已包含在文件中后签署文件。MerryXiaoValidationEngineerCompliance&ValidationaresigningtoconfirmcompliancewithapplicablepharmaceuticalregulatoryagencyrequirementsandCompanystandards.法规和验证的签字确认其符合制药法规组织的要求和公司标准。JessicaHuValidationAssistantManagerBelindaChenQualityHeadSiteDirectorissigningtoconfirmprojectsinsiteandprovidetherequiredresourcesforvalidationactivities.工厂总监的签字是确认工厂需要进行的项目和为工厂验证活动提供需要的资源。ShirleneMGoldsbroughSiteDirectorDistributionList分发清单NoDistributionRequired不需要分发FieldExecutionCopy在执行过程中需要复印件CopyNo复印件编号IssuedTo(Name/Department)交给（姓名／部门）IssuedBy(C&V)由谁生效（法规和验证组）DateofIssue生效日期123GlaxoSmithKlineTSK&FTitle:题目SiteValidationMasterPlanofTSK&F中美天津史克工厂验证主计划DocumentNo文件编号DocumentType文件类型PageNumber页码SVMP_16SiteValidationMasterPlan2of491目的Objective...........................................................................................................................32验证的指导方针与规程ValidationPolicesandProcedures.........................................................43责任Responsibilities.................................................................................................................64验证的时间表与进展SchedulesandProgress.........................................................................952007年度完成的验证项目ValidationProjectscompletedin2007.............................................2862007年度暂停和取消的验证项目ValidationProjectsonholdandcancelledin2007.................377修订历史RevisionHistory.........................................................................................................42GlaxoSmithKlineTSK&FTitle:题目SiteValidationMasterPlanofTSK&F中美天津史克工厂验证主计划DocumentNo文件编号DocumentType文件类型PageNumber页码SVMP_16SiteValidationMasterPlan3of491目的Objective该工厂验证总计划是为了提供一个对中美天津史克制药有限公司的验证工作的综合描述。具体而言，该计划将：ThepurposeoftheSVMPistoprovideacomprehensiveoverviewofallvalidationactivitiesinTSKF.Theplanwillcoverfollowing:1)列出公司在进行验证工作时所必须遵循的指导方针与指南。Listthegoverningpoliciesandproceduresthatmustbefollowedinvalidationactivities.2)确定公司各部门和主要管理人员在验证工作中的主要责任。Definetheresponsibilitiesofkeypersonnelinvalidationactivities.3)列出公司目前主要的验证工作类别以及与其相关的验证主计划。Listthemainvalidationactivitiesinthesiteandthereferencestothevalidationmasterplans.4)描述公司目前正在进行和计划将要进行的验证工作和项目的程序和进展。Describetheexecutionstatusofvalidationactivitiesthatareinprocessorinplan.GlaxoSmithKlineTSK&FTitle:题目SiteValidationMasterPlanofTSK&F中美天津史克工厂验证主计划DocumentNo文件编号DocumentType文件类型PageNumber页码SVMP_16SiteValidationMasterPlan4of492验证的指导方针与规程ValidationPolicesandProcedures验证类别ValidationType文件编号DocumentNo文件名称DocumentName验证生命周期TheValidationLifeCycleGQP1204TheValidationLife–Cycle验证生命周期ValidationDocumentation验证文件ValidationMaintenance验证维护ImpactAssessment影响评估DesignQualification设计确认ValidationReview验证回顾验证生命周期ValidationlifecycleGQMP1008验证生命周期Validationlifecycle清洗验证CleaningValidationGQP6202CleaningValidation清洁验证分析方法与设备验证AnalyticalMethod&EquipmentValidationGQP7113ValidationofAnalyticalEquipmentandAnalyticalMethods分析设备与分析方法的验证计算机系统的验证ComputerValidationGQP1205GQP3202ComputerisedSystemValidation计算机系统验证RegulatedElectronicRecordsandSignatures法规要求的电子记录和电子签名注释：GQP=GlobalQualityPolicy(葛兰素史克集团）全球质量方针GQMP=GlobalQualityManagementProcess(葛兰素史克集团）全球质量管理规程GlaxoSmithKlineTSK&FTitle:题目SiteValidationMasterPlanofTSK&F中美天津史克工厂验证主计划DocumentNo文件编号DocumentType文件类型PageNumber页码SVMP_16SiteValidationMasterPlan5of49生产厂关键规程列表如下：Keysiteproceduresarelistedinthetablebelow.文件名称DocumentName文件编号SOPNumber工厂验证管理规程SiteValidationApproachPSOP1432生产设施验证规程ManufacturingFacilityValidationSOP1433验证草案和报告的生成GenerationofQualificationProtocolsandReportsSOP1438设计确认程序ValidationProcedureforDesignQualificationSOP1439安装确认程序ValidationProcedureforInstallationQualificationSOP1440运行确认程序ValidationProcedureforOperationalQualificationSOP1441性能确认程序ValidationProcedureforPerformanceQualificationSOP1442计算机验证方法ComputerValidationApproachSOP1443清洁验证CleaningValidationSOP1445维护系统的验证状态MaintainingSystemstheValidatedStatusSOP1446控制系统ControlSystemValidationApproachSOP1447系统影响性评估SystemImpactAssessmentSOP1451分析仪器验证通则AnalyticalEquipmentValidationApproachSOP0832化学检验方法验证规程ChemicalAnalysisMethodValidationApproachSOP0834GlaxoSmithKlineTSK&FTitle:题目SiteValidationMasterPlanofTSK&F中美天津史克工厂验证主计划DocumentNo文件编号DocumentType文件类型PageNumber页码SVMP_16SiteValidationMasterPlan6of493责任Responsibilities部门/人员Department/Personnel责任Responsibility质量保证部验证组QAValidation负责制订与回顾年度SVMPResponsibleforpreparingandreviewingSVMP负责制订与回顾各项目验证主计划Responsibleforpreparingandre