準(zhǔn)備FDA認(rèn)證前檢查中英文對(duì)照教學(xué)課件

PreparingforfDaPreapprovalInspections準(zhǔn)備FDA認(rèn)證前檢查RichardNeedham,RFlAssociatesPurposeofapre-Approvalinspection(dMeorAnda)認(rèn)證前檢查的目的(DMF或ANDA)aEnsurethatthefacilities,equipment,andinstrumentsaresuitableforproducingaqualityproduct確保設(shè)施,設(shè)備和儀器適合高質(zhì)量產(chǎn)品的生產(chǎn)aEnsurethatthequalitysystemisfunctioningcorrect/y確保質(zhì)量體系運(yùn)行正常aEnsurethatproductismanufacturedunderCGMPs確保在CGMPs指導(dǎo)下進(jìn)行產(chǎn)易生產(chǎn)一RichardNeedhamRFlAssociatesPurposeofapre-ApprovalInspection認(rèn)證前檢驗(yàn)的目的dEnsurethatdatasubmittedintheandaordmesubmissionissupportedbyrawdataatthefacility確保在ANDA或DMF文件中提交的數(shù)據(jù)以設(shè)腦的原始數(shù)據(jù)為依據(jù)1DataandoriginalrecordsmustbedocumentedaccordingtoCGMPstandards原始數(shù)據(jù)和記錄必須根據(jù)cGMP標(biāo)準(zhǔn)進(jìn)行dEnsurethattheandaordmesubmissionisanaccuratereflectionofwhatisbeingdoneatthefacility確統(tǒng)ANDA或DMF中提父的是設(shè)畫正在進(jìn)行的情況的準(zhǔn)確反應(yīng)RichardNeedhamRFlAssociatesThepre-ApprovalInspection(PAl認(rèn)證前檢查(PAI)日WhenistheDMFreviewedbyfDa?DMF什么的候被FDA審查?Onlyaftertheandaholderfilestheandaandreferstothe只有在ANDA持有人將ANDA歸檔并提交到DMF后IfnoANDaisfiled,theDMFisfiledawaywithoutreview.如果ANDA沒有歸檔,那么DMFJiang將其移開不進(jìn)行審查BHowever,theDMfholdershouldstillupdatethedmfthroughannualreportsandDMFamendmentstotheFDA然而,DMF持有人仍應(yīng)通過年度報(bào)告和DMF修訂將更新提交紛FDA口Thisway,theDMFwillbeup-to-datewhenreviewed這樣,DMF被審查的將是最新的RichardNeedhamRFlAssociatesThepre-ApprovalInspection(PAl認(rèn)證前檢查(PAI)aWhenistheANDAreviewedbyFDA?FDA什么時(shí)候?qū)彶锳NDAAftertheandaholderfilestheandaANDA持有人將ANDA歸檔后aBecauseofbacklogsexpectatleast6monthdelaybeforereviewing由于積壓,預(yù)計(jì)至少延遲6個(gè)月才能被審查DWhenistheInspectionscheduled?什么時(shí)候進(jìn)行預(yù)先審查AftertheaNdaissatisfactorilyreviewedANDA審查圓滿后aDeficiencylettermaybeissued后件缺乏可能成為問題DMoreinformationmayberequested可能會(huì)要求史多的信息一RichardNeedhamRFlAssociatesFlowofthepre-ApprovalInspection認(rèn)證前檢査流程aFDAPersonne/involvedFDA涉及人員Twopeopleareusuallyinvolved:通常涉及兩個(gè)人DFDAInvestigator(Productionissues)FDA調(diào)查人員(生產(chǎn)問題)DFDaChemist(LaboratoryIssuesFDA化驗(yàn)師(實(shí)驗(yàn)室問題)Generallytheywillworkseparately般來說,他們將分開工作DTherefore,preparationfortwopeopleisneeded因此,需要配備兩個(gè)人RichardNeedhamRFlAssociatesFlowofthepre-ApprovalInspection認(rèn)證前檢查流程aPreparationfortwopeoplegenerallymeans配備兩個(gè)人通常是指TwoInterpreters(providedbythefirm,atpresent兩名翻譯員(目前由公司提供的)aTheinterpretersareextremelyimportanttothesmoothrunningoftheinspection翻譯員對(duì)于檢查順利進(jìn)行是非常重要的Twoadjacentconferencerooms兩個(gè)相鄰的會(huì)議室日Investigator調(diào)查人員Chemist化驗(yàn)師RichardNeedham,RFLAssociatesFlowofthepre-ApprovalInspection認(rèn)證前檢查口Inspectionw∥usuallytake4fu∥days檢查通常需要4天InitialMeeting(1-11hours)首次會(huì)議(1-1個(gè)半小時(shí))WalkthroughofWarehouses,Production,QCLaboratory(5-6hours)倉庫,生產(chǎn),QC實(shí)驗(yàn)室巡檢(5-6小時(shí))DocumentReview(2-212days)文件審查(2-2天半)■Closeout(1-2hours)總結(jié)(1-2小時(shí))DHowever,theFDAInspectorsmaychangethisschedule然而,FDA檢查員可能會(huì)改變這個(gè)時(shí)間表Bepreparedfortheunexpected做好出現(xiàn)意外的準(zhǔn)備RichardNeedhamRFlAssociatesFlowofthepre-ApprovalInspection認(rèn)證前檢查流程DInitia/Meeting(1-11/2hours)首次會(huì)議(1-1個(gè)半小時(shí))Introductionsandexchangeofbusinesscards介紹并交換名片DThemostresponsiblepersonatthefirmshouldbepresent該公司負(fù)責(zé)人應(yīng)該在場(chǎng)DQA,Production,QCRepresentativesshouldbepresentQA,生產(chǎn),QC代表應(yīng)該在場(chǎng)RichardNeedhamRFLassociatesFlowofthepre-ApprovalInspection認(rèn)證前檢查流程DInitia/Meeting(1-12hours)一首次會(huì)議(1-1個(gè)半小時(shí))dMakesurethateverypersonisidentifiedbyn10alame確保每個(gè)人標(biāo)注姓名Nameandtitledisplayedatinitialmeeting姓名和標(biāo)題呈現(xiàn)在首次會(huì)議上Nametagsonuniformduringinspection檢査期間所有姓名標(biāo)簽格式應(yīng)統(tǒng)一Cons