**********(SHANGHAI)LTD上海******生物制品有限公司Doc.No.:QA004編號：STANDARDOPERATIONPROCEDURE標(biāo)準(zhǔn)操作程序VersionNo.:7.0版本號質(zhì)量管理體系QualityManagementSystemSupersededDate:29/04/2010替代版本日期PagePAGE1of13頁數(shù)EffectiveDate:生效日期Anyprintedcopyofthisdocumentisnone-controlledunlessithastheblueQAControlledstamp.Lastsaved保存時間SAVEDATE\@"DD/MM/yyyyh:mmam/pm"24/10/201111:34PM總頁數(shù):15頁(13頁＋2個附件:2頁)Totalpages:15pages(13pages+2appendices:2pages)目錄TABLEOFCONTENTS:TOC\o"1-2"\h\z\u1. 目的OBJECTIVE 22. 范圍SCOPE 23. 職責(zé)RESPONSIBILITIES 24. 步驟PROCEDURE 34.0 流程圖Flowchart 34.1 質(zhì)量管理體系QualityManagementSystem 44.2 優(yōu)良藥品生產(chǎn)管理規(guī)范GoodManufacturingPractice 54.3 管理原則ManagementPrinciple 65. 術(shù)語GLOSSARY 136. 參考文件REFERENCES 137. 附件APPENDIX 138. 其他相關(guān)信息RELATEDFORMSANDTRAININGMATERIAL 138.1 表格Forms 138.2 培訓(xùn)資料TrainingMaterial 13**********************(SHANGHAI)LTD上海******生物制品有限公司Doc.No.:QA004編號：VersionNo.:7.0版本號PagePAGE3of13頁數(shù)EffectiveDate:生效日期目的 OBJECTIVE建立一個結(jié)合管理原則和GMP要求的質(zhì)量管理體系,從而為客戶提供好的產(chǎn)品質(zhì)量,符合法規(guī)的要求并促使上海*****有限公司持續(xù)不斷的進(jìn)步。ToestablishsystemtointegratethemanagementprinciplewithGoodManufacturingPracticerequirementsoastodeliverthequalityforthecustomers,compliancefortheregulatorsandcontinuousimprovementfortheGSKBS.范圍 SCOPE此程序適用上海*****生物制品有限公司內(nèi)所有與質(zhì)量有關(guān)的操作ThisprocedureappliestoallactivitiesrelatedqualitythroughoutGSKBS職責(zé) RESPONSIBILITIES3.1工廠經(jīng)理應(yīng)-保證足夠的資源以建立、執(zhí)行及維護(hù)工廠的質(zhì)量體系-指定并授權(quán)QMS倡導(dǎo)者負(fù)責(zé)將QMS的要求有效地融入工廠質(zhì)量體系-保證各部門經(jīng)理在他們管理的區(qū)域執(zhí)行QMS3.2QMS倡導(dǎo)者負(fù)責(zé)管理工廠QMS執(zhí)行的過程3.3質(zhì)量部負(fù)責(zé)建立，維護(hù)以及改進(jìn)質(zhì)量管理體系。確保QMS執(zhí)行過程中產(chǎn)生的質(zhì)量/符合性風(fēng)險能夠很好地被管理3.4所有員工必須遵守質(zhì)量管理體系。3.5管理層負(fù)責(zé)檢查回顧質(zhì)量管理體系的執(zhí)行情況,并對改進(jìn)質(zhì)量體系提供相應(yīng)的資源詳細(xì)職責(zé)參加第四章3.1Itistheresponsibilityofsitemanagerto-Ensureresourcesaremadeavailabletoestablish,implementandmaintainthelocalqualitysystem.-AssignandempoweraQMSChampiontotakeresponsibilityforeffectiveintegrationofQMSrequirementsintothelocalsystem.-EnsuredepartmentmanagersimplementQMSwithintheirareaofaccountability.3.2ItistheresponsibilityofQMSChampiontomanagelocalQMSimplementationprocess.3.3Itistheresponsibilityofthequalitydept.toestablish,maintainandimprovethequalitymanagementsystem.Toensurequality/compliancerisksarisingfromimplementationareappropriatelymanaged3.4Itistheresponsibilityofallstafftofollowthequalitymanagementsystem3.5Itistheresponsibilityofmanagementteamtoreviewtheimplementationofqualitymanagementsystem,andprovidetherelatedresourceforitsimprovement.Refertochapter4fordetailedresponsibilities

步驟PROCEDURE流程圖Flowchart4.1QMS質(zhì)量管理體系4.2.1.8.IncidentManagement4.1QMS質(zhì)量管理體系4.2.1.8.IncidentManagement事件管理4.3.1.6Improve提高4.3.1.3Communicate溝通4.2.1.4Facilities設(shè)施4.2.1.5MaterialandProductControl物料和產(chǎn)品控制4.2.1.3Documentation&Data文件和數(shù)據(jù)4.2.1.6ProcessAssurance過程保證4.2.1.1Management管理4.2.1.2Personnel人員4.2.1.7.AnalyticalControls分析控制4.3.1.5Review回顧4.3.1.4Measure監(jiān)測4.3.1.2Organize組織4.3.1.1Plan計(jì)劃4.2GoodManufacturingPractice優(yōu)良的藥品生產(chǎn)管理規(guī)范4.3ManagementPrinciple管理原則**********************(SHANGHAI)LTD上海******生物制品有限公司Doc.No.:QA004編號：VersionNo.:7.0版本號PagePAGE8of13頁數(shù)EffectiveDate:生效日期質(zhì)量管理體系QualityManagementSystem介紹Introduction:上海*****的質(zhì)量體系是一個具有生命力的系統(tǒng),全面的政策,支持的過程和與法規(guī)要求一致的程序,并在公司內(nèi)部進(jìn)行積極的管理QualityManagementsystemisalivingsystemwithcomprehensivepolicies,supportedbyprocessandprocedurealignedtoregulatoryrequirementandrequiringactivemanagementinGSKBS該體系的輸入為:Inputofthissystem-GlobalRequirements(includingGQPs,GQMPs,GSOPs,GlobalQualityCouncilCommunicationandGlobalQualityAlert……)全球要求（包括GQPs,GQMPs,GSOPs,全球質(zhì)量管理會議溝通和質(zhì)量警報(bào)）-ContinuousImprovementbasedonprocess基于過程的持續(xù)改進(jìn)-RegulatoryRequirements法規(guī)政策詳細(xì)步驟DetailedstepID操作步驟（什么）Action(What)誰(職責(zé)）Who(func.)控制,指標(biāo),規(guī)則（QA,EHS,Fi…）Controls,KPIs,Rules(QA,EHS,Fi…)監(jiān)控體系3個輸入的變化Monitorchangeof3inputofQMS質(zhì)量經(jīng)理QualityMgr.N/A組織差距分析Organizegapanalysis.QMS倡導(dǎo)者QMSChampionQMS差距分析表的編號為GA-年份-序列號，序列號從001開始TheNo.ofQMSgapanalysisformisGA-Year-SerialNo.,startingfrom001.根據(jù)全球QMS的變更情況，填寫QA004-F1的A部分后交相關(guān)指定人員。WheneverthereisanychangeofglobalQMS,fillinpartAofQA004-F1,andthenhandoverthisformtotheassignedperson.執(zhí)行差距分析PerformgapanalysisSOP作者或指定人員SOPauthororassignedperson分析前，需要從My-Learning上取得證書，然后完成QA004-F1的B部分。Beforegapanalysis,thepersonmustacquirethecertificateviamy-learning.CompletethePartBofQA004-F1.對差距執(zhí)行風(fēng)險評估并確認(rèn)行動計(jì)劃Performriskassessmentofthegapandconfirmtheactionplan執(zhí)行差距分析人員與相關(guān)部門經(jīng)理RelatedpersonandDept.Mgr.whoperformedgapanalysis參見QA053，并填寫QA004-F1的C部分。RefertoQA053,fillinpartCofQA004-F1.對于風(fēng)險評估認(rèn)為對產(chǎn)品安全、質(zhì)量或有效性沒有影響者，應(yīng)作為“差異”進(jìn)行記錄，可以不再采取進(jìn)一步行動。Forthedifferencesassessedashavingnoimpactonproductsafety,qualityorefficacy,itshouldberecordedasadifference.Nofurtheractionisrequired.對于風(fēng)險評估認(rèn)為可能對產(chǎn)品安全、質(zhì)量或有效性有影響者，則應(yīng)作為“差距”，必須采取進(jìn)一步行動消除差距，降低風(fēng)險。參見QA053和QA052。Forthedifferencesassessedashavingpotentialimpactonproductsafety,qualityorefficacy,itshouldbeconsideredasagap.Furtheractionmustbetakentomitigatethegapandrisk.RefertoQA053&QA052.行動計(jì)劃必須在四個月內(nèi)制定并完成（QMS文件預(yù)放行階段一個月，生效后三個月，共計(jì)四個月）Theactionplanningmustbescheduledandcompletedwith4months.(QMSdocumentationpre-releaseonemonth,3monthsafterbeingeffective,4monthsintotal).監(jiān)控計(jì)劃執(zhí)行的過程MonitortheprogressofactionplanningSOP作者或指定人員SOPauthororassignedperson填寫QA004-F1的D部分，并通知QMS倡導(dǎo)者。FillinthePartDofQA004-F1，andtheninformQMSChampion.確認(rèn)差距已經(jīng)消除ConfirmGapisclosedQMS倡導(dǎo)者QMSChampion填寫QA004-F1的E部分FillinthePartEofQA004-F1回顧和提高質(zhì)量管理體系執(zhí)行ReviewandImprovetheImplementationofQMS.管理層ManagementTeam-審計(jì)（自檢，內(nèi)審和全球?qū)徲?jì)）Audit(self-inspection,internalandglobalaudit)-定期回顧PeriodicReview優(yōu)良藥品生產(chǎn)管理規(guī)范GoodManufacturingPractice介紹Introduction優(yōu)良藥品生產(chǎn)管理規(guī)范是藥品生產(chǎn)的最低要求,也是確定我們做正確的事,并正確地做事的過程.GoodManufacturingPracticeistheregulatoryrequirementfordrugmanufacturing,andaprocesstoensuringthatwedorightthings,anddothingsright.從八個方面進(jìn)行介紹IntroduceGMPfromeightsections:管理Management人員Personnel文件和數(shù)據(jù)Documentation&Data設(shè)施Facilities物料與產(chǎn)品控制MaterialandProductControl過程保證ProcessAssurance分析控制AnalyticalControls事件管理IncidentManagement所有有關(guān)的文件可以參考S:\SOP\ControlledDocuments。AllthoseinformationcouldreferenceS:\SOP\ControlledDocuments.詳細(xì)步驟Detailedsteps:N/A管理原則ManagementPrinciple介紹Introduction六大管理原則是質(zhì)量管理體系中必不可少的部分：SixManagementPrinciplesareessentialtoQualityManagementSystem計(jì)劃Planning組織Organizing溝通Communicating監(jiān)測Measuring回顧Reviewing提高Improving計(jì)劃Planning計(jì)劃是保證質(zhì)量完全地被融入到公司組織戰(zhàn)略，運(yùn)營計(jì)劃和商業(yè)流程中。上海工廠的計(jì)劃有以下幾種：Planningistoensurequalityisfullintegratedintotheorganization’sstrategicandoperationalplanningandbusinessprocesses.TheplansinGSKBSareasfollows:上海工廠戰(zhàn)略GSKBSAlignmentGrid質(zhì)量計(jì)劃QualityPlan風(fēng)險管理（風(fēng)險降低計(jì)劃）RiskManagement(mitigationplan)驗(yàn)證主計(jì)劃ValidationMasterPlan培訓(xùn)計(jì)劃TrainingPlan審計(jì)計(jì)劃（自檢和內(nèi)審）AuditPlan(SelfInspection&InternalAuditPlan)供應(yīng)商和分銷商審計(jì)計(jì)劃SupplierandDistributorAuditPlan預(yù)防性維修和校驗(yàn)計(jì)劃PreventiveMaintenance&CalibrationPlan通過這些計(jì)劃，將質(zhì)量的目標(biāo)和目的貫穿到整個組織機(jī)構(gòu)中Throughthoseplans,ensurequalitygoalsandobjectivesarecascadeddownthroughouttheorganization.組織Organizing組織通過提供必要財(cái)力，物力和人力來保證及時的按照有關(guān)質(zhì)量要求的完成商業(yè)和運(yùn)營計(jì)劃Organizingistoproviderequiredfinancial,materialandhumanresourcestoensurecompleteandtimelydeliveryofthebusinessplanandoperationalcompliancewithallrelevantqualityrequirements.上海工廠的質(zhì)量部是獨(dú)立的部門，以確保其可以獨(dú)立及客觀地行使質(zhì)量控制職責(zé)。參見工廠的組織結(jié)構(gòu)圖，該組織結(jié)構(gòu)圖應(yīng)該是實(shí)時更新的，且至少每年回顧一次。TheQualityDepartmentisindependentinGSKBS.Theorganizationalstructuremustallowthelocalqualityorganizationtohavethenecessaryindependenceandobjectivityintheperformanceofitsqualityresponsibilities.RefertoSiteOrganizationChart.ThisOrganizationChartshouldbeuptodate,andshouldbereviewedatleastonceayear.質(zhì)量和GMP的職責(zé)個人職責(zé)描述和個人發(fā)展計(jì)劃中定義了。TheresponsibilitiesforimplementingandmaintainingqualityandGMParewelldefinedinindividualjobdescriptionandPersonnelDevelopmentPlan.溝通Communicating有效的溝通能促進(jìn)質(zhì)量意識的提高，并且鼓勵和取得每個人員在質(zhì)量上的承諾Effectivecommunicationisessentialtopromoteawarenessofqualityandtoencourageandsecurethecommitmentofeveryonetoquality當(dāng)前工廠的溝通機(jī)制有以下幾種ThecurrentcommunicationmechanismsinGSKBSare-工廠質(zhì)量部與其他部門的溝通-CommunicationbetweenGSKBSQAandotherdepartments:類型Type內(nèi)容Subject頻率Frequency參與者Participants質(zhì)量QA/RA價值鏈VS技術(shù)服務(wù)/商務(wù)TS/BSEHS工廠Site培訓(xùn)Training藥品質(zhì)量管理規(guī)范GMPfreshtraining至少每年一次Atleastonceayear全體All全體All全體All全體All經(jīng)理Mgr文件Documentation視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定AttenduponrequestQualitylearning(Remarks,Deviation,Complaint,globalalert,FDAinspectionresultinformationshare)視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest質(zhì)量部會議QAMeeting質(zhì)量執(zhí)行狀態(tài)和計(jì)劃QualityImplementationStatusandPlanning至少每月一次Atleastonceamonth全體All視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest視情況而定Attenduponrequest質(zhì)量管理會議QualityCouncilMeeting詳見附件1RefertoAppendix1每月一次Monthly經(jīng)理Mgr經(jīng)理Mgr經(jīng)理Mgr經(jīng)理Mgr經(jīng)理Mgr全體員工會議StaffMeeting質(zhì)量情況報(bào)告&質(zhì)量管理體系報(bào)告QualityStatusReportQMSStatusReport每季度一次Quarterly全體All全體All全體All全體All全體All-工廠質(zhì)量部與Biological全球質(zhì)量部的溝通-CommunicationbetweenGSKBSQAandBiologicalGlobalQualityFunction:類型Type內(nèi)容Subject頻率Frequency參與者Participants質(zhì)量管理會議溝通QualityCouncilCommunication工廠質(zhì)量管理會議紀(jì)要或附件2RefertoSiteQCMeetingMinutesorAppendix2每月一次電話會議或使用附件2MonthlyTCorbyAppendix2GSKBIO全球QAGSK-BIOGlobalQA質(zhì)量警報(bào)QualityAlert分享全球特定質(zhì)量問題Sharingglobalspecificqualityissues視情況而定AttenduponrequestGSKBIO全球QAGSK-BIOGlobalQA審計(jì)Audits質(zhì)量體系審計(jì)QMSAudit每二年一次Onceeverytwoyears全球?qū)徲?jì)員CorporateAuditor-工廠質(zhì)量部與供應(yīng)商/分銷商的溝通-CommunicationbetweenGSKBSQAandSupplier/Distributor:類型Type內(nèi)容Subject頻率Frequency參與者Participants每月質(zhì)量報(bào)告MonthlyQualityReport分銷商質(zhì)量狀況和冷鏈數(shù)據(jù)DistributorQualityStatusandColdChainTransportationData每月一次Monthly分銷商質(zhì)量經(jīng)理DistributorQualityManager分銷商審計(jì)DistributorAudit分銷商質(zhì)量體系DistributorQMS視情況而定，至少每五年一次Attenduponrequest,atleastoncefiveyear分銷商Distributor供應(yīng)商審計(jì)SupplierAudit供應(yīng)商質(zhì)量體系SupplierQMS視物料情況而定AttenduponMaterial供應(yīng)商Supplier供應(yīng)商質(zhì)量問題溝通Qualityissuecommunicationwithsupplier供應(yīng)商質(zhì)量體系SupplierQMS視物料情況而定AttenduponMaterial供應(yīng)商Supplier-工廠質(zhì)量部與客戶/官方機(jī)構(gòu)的溝通-CommunicationbetweenGSKBSQAandCustomer/Regulatory:類型Type內(nèi)容Subject頻率Frequency參與者Participants每季度質(zhì)量報(bào)告QuarterlyQualityReport工廠質(zhì)量執(zhí)行狀態(tài)SiteQualityImplementationStatus每季度一次Quarterly政府部門RegulatoryAgency培訓(xùn)Training接受法規(guī)培訓(xùn)ReceivingneworupdatedRegulatoryRequirement視情況而定Attenduponrequest政府部門RegulatoryAgency審計(jì)Audit質(zhì)量體系審計(jì)GMSAudit視情況而定Attenduponrequest政府部門RegulatoryAgency參觀Visits檢查Inspection視情況而定Attenduponrequest政府部門RegulatoryAgency客戶溝通CustomerCommunication投訴，電話咨詢Complaint,Callenquire視情況而定Attenduponrequest客戶或病人CustomerorPatient參觀Visits分享GSK良好規(guī)范SharingGSK’sgoodpractice視情況而定Attenduponrequest客戶或病人CustomerorPatient監(jiān)測Measuring監(jiān)測是為了監(jiān)控質(zhì)量情況的結(jié)果，過失和錯誤Measuringistomonitorqualityresults,defectsanderrors.工廠的監(jiān)測有MeasuresinGSKBSare:-重要的績效指標(biāo)KPIs-異常事件調(diào)查和處理IncidentInvestigationandHandling-部門自檢Self-inspection利用監(jiān)測去確定需要改進(jìn)的方面Usethemeasurestoidentifyareasforimprovement.回顧Reviewing回顧是為了提高每個員工的質(zhì)量意識，并維持質(zhì)量在商業(yè)上的貢獻(xiàn)Reviewingistoraiseandsustainthequalityawarenesstoeveryoneandthequalitycontributiontothebusiness4.3.1.5.1回顧日常質(zhì)量活動的狀態(tài)Reviewroutinequalityactivitiesimplementationstatus.-偏差/備注Deviations/Remarks-變更管理ChangeManagement-投訴Complaint-驗(yàn)證Validation4.3.1.5.2回顧KPI的趨勢ReviewtrendofKPI例如：Forexample:-一次就做對RFT-QMS文件”inuse”百分比QMS“inuse”%-投訴支數(shù)比例和回復(fù)時間Complaintsdosesrate&responsetime-過期的CAPA狀態(tài)OverdueCAPAstatus-校驗(yàn)周期符合性Calibrationadherence4.3.1.5.3回顧計(jì)劃執(zhí)行情況Reviewplanimplementationstatus-質(zhì)量計(jì)劃QualityPlan-驗(yàn)證主計(jì)劃ValidationMasterPlan-供應(yīng)商全方位績效評估SupplierTPM-質(zhì)量管理體系差距分析QMSGapAnalysis-培訓(xùn)充分性回顧TrainingSufficiencyReview4.3.1.5.4周期性生產(chǎn)回顧PeriodicProductionReview每年一次，通常在第一季度完成，以下內(nèi)容應(yīng)被回顧：Onceperyear,normallydoneinthe1stquarteroftheyear,thecontentlistedbelowmustbereviewed.-列出所有需要回顧的產(chǎn)品批次Listingofallbatchesincludedinthereview-生產(chǎn)記錄趨勢（包括產(chǎn)量和中間控制）Productionrecordstrends(includingyieldoroutput,andin-processcontrol)-實(shí)驗(yàn)室記錄趨勢，超標(biāo)分析Laboratoryreleasetestingrecordtrends,OOS-穩(wěn)定性記錄趨勢Stabilitytestingrecordstrends,-產(chǎn)品和物料質(zhì)量標(biāo)準(zhǔn)和測試方法Productandmaterialspecificationsandtestmethods-留樣檢查RetentionSampleCheck-報(bào)廢，返工，再包裝和再加工Rejected,reworked,repackandreprocessbatchesofproductandmaterial-偏差Deviation-相關(guān)法規(guī)文件，藥典，其他市場要求，內(nèi)部標(biāo)準(zhǔn)文件，技術(shù)協(xié)議和TTS的最新符合性Conformancetouptodateandrelevantregistration,pharmacopoeia,andothermarketrequirement,internalstandarddocuments,TechnicalagreementsandTTS-新的注冊申請，再回顧期間申報(bào)的，批準(zhǔn)的或拒絕的申報(bào)資料包括入市后的承諾NewRegulatoryapplicationsandanyvariationstoregistereddetailssubmitted,grantedorrefusedduringthereviewperiodandincludinganypostmarketingcommitments-變更控制ChangeControl-驗(yàn)證狀態(tài)ValidationStatus-投訴趨勢，召回和退貨Complainttrends,RecallsandReturnedgoods.-關(guān)鍵設(shè)備和公用設(shè)施的性能CriticalEquipmentandutilitiesperformance,Exceededactionlimits.-供應(yīng)商表現(xiàn)SupplierPerformance4.3.1.5.5以上所有的內(nèi)容通過以下形式被回顧Allaboveitemswillbereviewedby:-質(zhì)量管理會議QualityCouncilMeeting-內(nèi)部審計(jì)InternalAudit-驗(yàn)證回顧報(bào)告ValidationReviewReport-周期性生產(chǎn)回顧（格式參見GQG5008）PeriodicProductionReview(refertoGQG5008forPPRtemplate)QMS執(zhí)行的有效性必須通過自檢和監(jiān)控審計(jì)（L2及L3審計(jì)）進(jìn)行評估。Theon-goingeffectivenessofQMSimplementationmustbeassessedthroughselfinspectionandmonitoringaudits(L2andL3audit)whereperformed.4.3.1.5.6工廠質(zhì)量管理會議的目的ThepurposeofSiteQualityCouncilMeeting按照Annex1的章程逐項(xiàng)進(jìn)行回顧，跟蹤上次會議的行動，通報(bào)當(dāng)月值得關(guān)注的質(zhì)量相關(guān)事件，確定需采取的行動計(jì)劃及其責(zé)任人、完成時間。對于Part7,8-Validation,Calibration，應(yīng)通報(bào)相關(guān)偏差，并確保預(yù)防糾正措施恰當(dāng)有效。ThecouncilisconductedfollowingthecharterinAnnex1,includingthefollowupofLastcouncil,communicatetheoutstandingissuessubjectedtoqualitymanagement,andthenconfirmtheactionplanwithitsowner&duedate.ForPart7,8-Validation&Calibration,therelativedeviationmustbediscussedtoensuretheCAPAeffectiveness.4.3.1.5.7QMS執(zhí)行的有效性必須通過自檢和監(jiān)控審計(jì)(L2內(nèi)審及L3Corporate審計(jì))進(jìn)行評估。Theon-goingeffectivenessofQMSimplementationmustbeassessedthroughselfInspectionandmonitoringaudits(L2InternalauditandL3Corporateaudit)whereperformed.提高Improving提高是為了預(yù)防質(zhì)量事故的發(fā)生，最終達(dá)到卓越Improvingistopreventthequalityproblemandissue,ultimatelydeliverindustrialExcellence.在上海工廠，持續(xù)改進(jìn)的建議通常來源于InGSKBS,therecommendationsforthecontinuousimprovementisusuallyderivedfrom:-風(fēng)險管理流程Riskmanagementprocess-變更管理系統(tǒng)ChangeManagementsystem-質(zhì)量管理會議QualityCouncil-周期性生產(chǎn)回顧PeriodicProductionReview-驗(yàn)證回顧報(bào)告ValidationReviewReport-偏差處理DeviationHanding持續(xù)改進(jìn)的進(jìn)度通過以下流程來跟蹤和回顧：Theprogressoftheactionsisfollowedandreviewedby:-糾正預(yù)防措施系統(tǒng)CorrectiveactionandpreventiveactionsystemGSKBS根據(jù)國家食品藥品監(jiān)督管理局《關(guān)于推動藥品生產(chǎn)企業(yè)實(shí)施藥品質(zhì)量受權(quán)人制度的通知》（國食藥監(jiān)安〔2009〕121號），及滬藥監(jiān)安〔2009〕495號的要求，執(zhí)行藥品質(zhì)量受權(quán)人制度。由質(zhì)量保證部經(jīng)理作為GSKBS質(zhì)量受權(quán)人，經(jīng)企業(yè)法人代表授權(quán)批準(zhǔn)，并提交上海食品藥品監(jiān)督管理局備案批準(zhǔn)。AccordingtothenoticefromSFDA（國食藥監(jiān)安〔2009〕121號），andSHFDA滬藥監(jiān)安〔2009〕495號,GSKBSexecutethesystemof“QualifiedPerson”.ManagerofqualityassurancedepartmentisassignedtobeQPofGSKBS.He/sheisauthorizedbyCorporateRepresentative,andisregisteredinSHFDA.4.3.2.1質(zhì)量受權(quán)人按規(guī)定行使以下職責(zé)：ThemainresponsibilityofQPisasbelow-負(fù)責(zé)保證企業(yè)質(zhì)量管理體系的有效運(yùn)行Ensuretheeffectivenessofqualitymanagementsystem-負(fù)責(zé)對影響產(chǎn)品質(zhì)量的關(guān)鍵管理活動行使決定權(quán)Finalapprovalforkeydocumentationswhichcouldaffectproductquality-對于產(chǎn)品質(zhì)量有重大影響的情況行使否決權(quán)Ownthevetorightofkeyproceedings-參與或負(fù)責(zé)與藥品質(zhì)量相關(guān)的其他工作Participateorresponsefortheworksrelatedtoproductquality-負(fù)責(zé)與藥品監(jiān)督管理部門的溝通ResponsibleforthecommunicationwithFoodandDrugAdministration.具體職責(zé)參見相關(guān)法規(guī)文件。Detailedresponsibilityrefertorelevantregulations.4.3.2.2因工作需要，藥品質(zhì)量受權(quán)人可將質(zhì)量管理的部分具體工作轉(zhuǎn)授權(quán)給轉(zhuǎn)受權(quán)人，但藥品質(zhì)量受權(quán)人必須對轉(zhuǎn)授權(quán)的這部分質(zhì)量管理工作負(fù)責(zé)（即授權(quán)不授責(zé)）。轉(zhuǎn)受權(quán)人具有相應(yīng)專業(yè)技術(shù)資格和工作經(jīng)驗(yàn)與轉(zhuǎn)授工作內(nèi)容相適應(yīng)的，其培訓(xùn)由藥品質(zhì)量受權(quán)人負(fù)責(zé)組織。轉(zhuǎn)受權(quán)人不得再次轉(zhuǎn)授權(quán)其他人承擔(dān)相關(guān)工作。Toadaptroutinework,QPcouldassignsomerightstoadeputy.However,QPistheresponsiblepersonfortheseauthorizations.Thedeputyshouldhavesuitablecertificationandexperienceofrelevantwarrant.ThetrainingforadeputyisorganizedbyQP.Thedeputycannotassignhis/hercommissiontootherpeople.GLAXOSMITHKLINEBIOLOGICALS(SHANGHAI)LTD上海葛蘭素史克生物制品有限公司Doc.No.:QA004編號：VersionNo.:7.0版本號PagePAGE13of13頁數(shù)EffectiveDate:生效日期術(shù)語 GLOSSARYGSKBS:GLAXOSMITHKLINEBIOLOGICALSSHANGHAILTD.上海*****生物制品有限公司參考文件 REFERENCESGQMP1001/1003/5008/5010GQP1101/2101/5302GQG5008GSOP9000004352附件 APPENDIXAppendix1GSKBSSiteQualityCouncilMeetingCharterAppendix2BiologicalShanghaiQualityCouncilCommunication其他相關(guān)信息RELATEDFORMSANDTRAININGMATERIAL表格FormsQA004-F1QMSGapAnalysisForm培訓(xùn)資料TrainingMaterialN/A=====Endofprocedure=====GLAXOSMITHKLINEBIOLOGICALS(SHANGHAI)LTD上海葛蘭素史克生物制品有限公司Appendix：1附件Doc.No.：QA004編號VersionNo.：7.0版本號PageNo.:1of1頁數(shù)EffectiveDate:生效日期Lastsaved保存時間SAVEDATE\@"DD/MM/yyyyh:mmam/pm"24/10/201111:34PMGSKBSSiteCouncilMeetingCharterSiteQualityCouncilPurpose&Deliverables:ReviewSiteQualityKPIs,RisksandQMSGaps–ShareGeneralinfo(deviations,complaints,changecontrols,etc…)TeamMembers&RolesPart1:QA&RASystemadequacyandimplementation,QA&RAOrganizationCouncilChairSiteManagerFacilitator:QA/RAManagerCouncilMembers:SiteManager,BS/TSManager,VSManager,IE/EHS,QA/RAManagerExtendedMember:AsperthetopicsifrequiredPart2:ValuestreamrelatedactivitiesPart3:IncidentandinvestigationHandlingPart4:TechnicalComplaintHandlingPart5:Audits-SupplierQualityAssessmentPart6:Audits-InternalAudits(L1&L2)QualityAssessmentPart7:Validation(equipment,computer)Part8:CalibrationPart9:ColdChainPart10:RiskManagementPart11:CAPAPart12:ChangeManagement(R1,R2,Doc,GPM,Technical…)MeetingPreparationMeetingOrganizationPreparations:ByQA/RAManagerReviewtheactionsfromlastmeetingReviewKPIsdataRisksreviewGeneralInfoDuration:2hrsMinutesproduction:distributedtheseconddaybyE-mailMinutesdistributedto:allparticipantsMeetingfrequency:MonthlyMinutesachievedchasedby:QA/RAManagerMeetingplace:GSKBSmeetingroom GLAXOSMITHKLINEBIOLOGICALS(SHANGHAI)LTD上海葛蘭素史克生物制品有限公司Appendix：2附件Doc.No.：QA004編號VersionNo.：7.0版本號PageNo.:PAGE1of1頁數(shù)EffectiveDate:生效日期Lastsaved保存時間SAVEDATE\@"DD/MM/yyyyh:mmam/pm"24/10/201111:34PMBiologicalsShanghaiQualityCouncilCommunicationDate:Date/Month/YearAuthor:QA/RAManagerTypeDescriptionSuccessesDecisionsIssuesandOpportunitiesForApproval上海******生物制品有限公司********(Shanghai)Ltd.變更歷史CHANGEHISTORYLastsaved保存時間SAVEDATE\@"DD/MM/yyyyh:mmam/pm"24/10/201111:34PM編號:QA004Doc.No標(biāo)題：GSKBS質(zhì)量管理體系Title:GSKBSQualityManagementSystem版本號VersionNo.生效日期EffectiveDate變更內(nèi)容DescriptionofChange變更理由(以及可能的技術(shù)變更)JustificationofChange(andTechnicalChangeNoifapplicable)Version1.0(QA004)01/04/2001N/ANewVersion2.0(QA004/01)10/03/2002MorepracticeAddannualqualityperform