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1、980SHANDONGTRIPARDUSPHARMACEUTICALSCO.,LTD.山東瑞博德制藥有限公司VALIDATIONDOCUMENT驗(yàn)證文件ValidationMasterPlanfortheFirstPhase2008年驗(yàn)證總計(jì)劃DocumentNo./文件編號(hào)：VD01001IssueNo./版本號(hào)：1IssueDate/頒發(fā)日期：2007年12月28日Writtenby/起草人:TonyLiu/劉福堂ValidationManager/驗(yàn)證經(jīng)理Signed/簽名:Date/日期:年月日Authorizedby/授權(quán)人:Ra
2、yYu/于瑞清TechnicalDirector/技術(shù)總監(jiān)Signed/簽名:Date/日期:年月日Documentcheck/審核Auditedby審核人Title職位Signature簽名Date日期JaneChang/常鴻雁ProductionDirector/生產(chǎn)總監(jiān)ProductionManager/生產(chǎn)經(jīng)理TonyLiu/劉福堂QAManager/QA經(jīng)理RockyZhao/趙巖EquipmentManager/設(shè)備經(jīng)理AnnaSong/宋曉燕QCManager/QC經(jīng)理EngineeringManager/維修經(jīng)理Storag
3、eManager/倉庫經(jīng)理LongBao/包龍CommercialDirector/商務(wù)總監(jiān)DistributionQAValidationarchive(Completedoriginal)QA驗(yàn)證檔案（完整的原件）TechnicalDirector(Copy)技術(shù)總監(jiān)（復(fù)印件）EngineeringManager(Copy)維修經(jīng)理（復(fù)印件）QCManager(Copy)QC經(jīng)理（復(fù)印件）ProductionManager(Copy)生產(chǎn)經(jīng)理（復(fù)印件）QAManager(Copy)QA經(jīng)理（復(fù)印件）PackingManager(Copy
4、)包裝經(jīng)理（復(fù)印件）ValidationManager(Copy)驗(yàn)證經(jīng)理（復(fù)印件）CommercialManager(Copy)商務(wù)經(jīng)理（復(fù)印件）ProductionDirector(Copy)生產(chǎn)總監(jiān)（復(fù)印件）TableofContent/目錄1Purpose/目的62Summary/概述62.1Companyintroductionandsummaryoffiststageproject/公司及一期工程項(xiàng)目概述62.2Scope/驗(yàn)證范圍62.3ValidationPolicy/驗(yàn)證方針63ValidationOrganization
5、alChartandPersonnelResponsibilities/驗(yàn)證組織結(jié)構(gòu)及人員職責(zé)73.1OrganizationalChart/組織結(jié)構(gòu)圖73.2ValidationCommittee/驗(yàn)證委員會(huì)73.3Validation/QualificationTeam/驗(yàn)證小組73.4Responsibilities/職責(zé)：73.4.1ResponsibilitiesofValidationCommittee/驗(yàn)證委員會(huì)職責(zé)73.4.2ResponsibilitiesofValidationTeam/驗(yàn)證小組職責(zé)：83.4.3AllD
6、epartmentalManagers/所有部門經(jīng)理職責(zé)93.5Training/驗(yàn)證培訓(xùn)94TheWritingandApprovalofValidationPlan,ProtocolandReport/驗(yàn)證計(jì)劃、方案、報(bào)告的起草審批程序95Documentation/文件95.1Content/文件范圍95.1.1ValidationPlan/驗(yàn)證計(jì)劃95.1.2ValidationProtocol/驗(yàn)證方案105.1.3ValidationReport/驗(yàn)證報(bào)告105.1.4ValidationCertificate/驗(yàn)證證書105.
7、2Format/文件格式105.3ValidationDocumentnumbering/驗(yàn)證文件的編號(hào)125.4Validation/QualificationArchiving驗(yàn)證/確認(rèn)歸檔126ValidationImplementation/驗(yàn)證實(shí)施126.1SafetyandHealth/安全與健康126.2ValidationClassificationandApplicableScope/本次驗(yàn)證所用到的驗(yàn)證分類與適用范圍126.2.1ProspectiveValidation/前驗(yàn)證126.2.2ConcurrentVali
8、dation/同步驗(yàn)證136.2.3Revalidation/再驗(yàn)證136.3ValidationImplementation/驗(yàn)證的實(shí)施146.4ValidationProje
