准备FDA认证前检查中英文对照教学课件

PreparingforfDaPreapprovalInspections准备FDA认证前检查RichardNeedham,RFlAssociatesPurposeofapre-Approvalinspection(dMeorAnda)认证前检查的目的(DMF或ANDA)aEnsurethatthefacilities,equipment,andinstrumentsaresuitableforproducingaqualityproduct确保设施,设备和仪器适合高质量产品的生产aEnsurethatthequalitysystemisfunctioningcorrect/y确保质量体系运行正常aEnsurethatproductismanufacturedunderCGMPs确保在CGMPs指导下进行产易生产一RichardNeedhamRFlAssociatesPurposeofapre-ApprovalInspection认证前检验的目的dEnsurethatdatasubmittedintheandaordmesubmissionissupportedbyrawdataatthefacility确保在ANDA或DMF文件中提交的数据以设脑的原始数据为依据1DataandoriginalrecordsmustbedocumentedaccordingtoCGMPstandards原始数据和记录必须根据cGMP标准进行dEnsurethattheandaordmesubmissionisanaccuratereflectionofwhatisbeingdoneatthefacility确统ANDA或DMF中提父的是设画正在进行的情况的准确反应RichardNeedhamRFlAssociatesThepre-ApprovalInspection(PAl认证前检查(PAI)日WhenistheDMFreviewedbyfDa?DMF什么的候被FDA审查?Onlyaftertheandaholderfilestheandaandreferstothe只有在ANDA持有人将ANDA归档并提交到DMF后IfnoANDaisfiled,theDMFisfiledawaywithoutreview.如果ANDA没有归档,那么DMFJiang将其移开不进行审查BHowever,theDMfholdershouldstillupdatethedmfthroughannualreportsandDMFamendmentstotheFDA然而,DMF持有人仍应通过年度报告和DMF修订将更新提交纷FDA口Thisway,theDMFwillbeup-to-datewhenreviewed这样,DMF被审查的将是最新的RichardNeedhamRFlAssociatesThepre-ApprovalInspection(PAl认证前检查(PAI)aWhenistheANDAreviewedbyFDA?FDA什么时候审查ANDAAftertheandaholderfilestheandaANDA持有人将ANDA归档后aBecauseofbacklogsexpectatleast6monthdelaybeforereviewing由于积压,预计至少延迟6个月才能被审查DWhenistheInspectionscheduled?什么时候进行预先审查AftertheaNdaissatisfactorilyreviewedANDA审查圆满后aDeficiencylettermaybeissued后件缺乏可能成为问题DMoreinformationmayberequested可能会要求史多的信息一RichardNeedhamRFlAssociatesFlowofthepre-ApprovalInspection认证前检査流程aFDAPersonne/involvedFDA涉及人员Twopeopleareusuallyinvolved:通常涉及两个人DFDAInvestigator(Productionissues)FDA调查人员(生产问题)DFDaChemist(LaboratoryIssuesFDA化验师(实验室问题)Generallytheywillworkseparately般来说,他们将分开工作DTherefore,preparationfortwopeopleisneeded因此,需要配备两个人RichardNeedhamRFlAssociatesFlowofthepre-ApprovalInspection认证前检查流程aPreparationfortwopeoplegenerallymeans配备两个人通常是指TwoInterpreters(providedbythefirm,atpresent两名翻译员(目前由公司提供的)aTheinterpretersareextremelyimportanttothesmoothrunningoftheinspection翻译员对于检查顺利进行是非常重要的Twoadjacentconferencerooms两个相邻的会议室日Investigator调查人员Chemist化验师RichardNeedham,RFLAssociatesFlowofthepre-ApprovalInspection认证前检查口Inspectionw∥usuallytake4fu∥days检查通常需要4天InitialMeeting(1-11hours)首次会议(1-1个半小时)WalkthroughofWarehouses,Production,QCLaboratory(5-6hours)仓库,生产,QC实验室巡检(5-6小时)DocumentReview(2-212days)文件审查(2-2天半)■Closeout(1-2hours)总结(1-2小时)DHowever,theFDAInspectorsmaychangethisschedule然而,FDA检查员可能会改变这个时间表Bepreparedfortheunexpected做好出现意外的准备RichardNeedhamRFlAssociatesFlowofthepre-ApprovalInspection认证前检查流程DInitia/Meeting(1-11/2hours)首次会议(1-1个半小时)Introductionsandexchangeofbusinesscards介绍并交换名片DThemostresponsiblepersonatthefirmshouldbepresent该公司负责人应该在场DQA,Production,QCRepresentativesshouldbepresentQA,生产,QC代表应该在场RichardNeedhamRFLassociatesFlowofthepre-ApprovalInspection认证前检查流程DInitia/Meeting(1-12hours)一首次会议(1-1个半小时)dMakesurethateverypersonisidentifiedbyn10alame确保每个人标注姓名Nameandtitledisplayedatinitialmeeting姓名和标题呈现在首次会议上Nametagsonuniformduringinspection检査期间所有姓名标签格式应统一Cons