FDA检查相关要求

PreparingforFDAInspectionsZhejiangApoleaMedicalTechnologyCompanyJanuary,20091RFLAssociatesPurposeofanANDA(DMF)pre-ApprovalInspection

ANDA（DMF）批准前检查的目的Ensurethatthefacilities,equipment,andinstrumentsaresuitableforproducingaqualityproduct

确保厂房，设备和仪器适用于生产合格的产品Ensurethatthequalitysystemisfunctioningcorrectly确保质量体系准确运行EnsurethatproductismanufacturedundercGMPs确保产品在cGMP条件下生产2RFLAssociatesPurposeofanANDA(DMF)pre-ApprovalInspectionEnsurethatdatasubmittedintheANDA/DMFsubmissionissupportedbyrawdataatthefacility确保在递交的ANDA/DMF中的数据是依据工厂的原始数据的DataandoriginalrecordsmustbedocumentedaccordingtocGMPstandards数据和原始记录必须根据cGMP标准记录存档EnsurethattheANDA/DMFsubmissionisanaccuratereflectionofwhatisbeingdoneatthefacility确保ANDA/DMF的递交是准确地反映工厂中所做的事情3RFLAssociatesTheANDA(DMF)Pre-ApprovalInspection(PAI)ANDA（DMF）批准前检查（PAI）WhenistheANDAreviewedbyFDA?FDA什么时候审核ANDA？AftertheANDAholderfilestheANDA在ANDA持有者递交ANDA之后Becauseofbacklogs,expectatleast6monthdelaybeforereviewing由于文件积压，在审核之前一般至少有6个月的延迟WhenistheInspectionscheduled?什么时候安排检查？AftertheANDAissatisfactorilyreviewed在对ANDA审核满意之后Deficiencylettermaybeissued缺陷信可能已经发布Moreinformationmayberequested可能要求更多的信息4RFLAssociatesFlowofthepre-ApprovalInspection批准前检查的流程FDAPersonnelInvolvedFDA涉及的相关人员

Twopeopleareusuallyinvolved:通常安排两个人Investigator调查员Chemist化学家Generally,theywillworkseparately通常他们分开工作Therefore,preparationfortwopeopleisneeded因此，需要准备两组人员5RFLAssociatesFlowofthepre-ApprovalInspectionPreparationfortwopeoplegenerallymeans:两组人员的准备TwoInterpreters(providedbythefirm,atpresent)两个翻译人员（目前由公司自己安排）Theinterpretersareextremelyimportanttothesmoothrunningoftheinspection翻译人员对于检查的顺利进行及其关键Twoadjacentconferencerooms相邻的两个会议室Investigator调查员Chemist化学家6RFLAssociatesFlowofthepre-ApprovalInspectionInspectionwillusuallytakeatleast4fulldays检查通常至少要满4个工作日InitialMeeting(1-1½hours)首次会议1-1.5小时WalkthroughofWarehouses,Production,QCLaboratory(5-6hours)仓库，生产，QC实验室检查5-6小时DocumentReview(3-31/2days)文件审核3-3.5天Closeout(1-2hours)结束1-2小时However,theFDAInspectorsmaychangethisschedule但是，FDA检查官员可能改变这种行程Bepreparedfortheunexpected准备好应对意外情况7RFLAssociatesFlowofthepre-ApprovalInspectionInitialMeeting(1-11/2hours)首次会议1-1.5小时Introductionsandexchangeofbusinesscards介绍和交换名片Themostresponsiblepersonatthefirmshouldbepresent公司的主要负责人必须出席QA,Production,QCRepresentativesshouldbepresentQA,生产，QC代表必须出席8RFLAssociatesFlowofthepre-ApprovalInspectionInitialMeeting(1-1½hours)首次会议1-1.5小时Makesurethateverypersonisidentifiedbyname确保每一个人都通过名字来识别身份Nameandtitledisplayedatinitialmeeting名字和职务在首次会议上要说明Nametagsonuniformduringinspection在检查期间名字和签名要一致Consideralsoahandoutwiththefollowinginformationforkeypeople:也要考虑为主要相关人员准备下列资料FullChinesename(andEnglishsurnameifapplicable)中文名全名（如果需要，英文名）Title职务Thumbnailphotograph小照片9RFLAssociatesFlowofthepre-ApprovalInspectionInitialMeeting(1-1½hours)首次会议1-1.5小时CompanyPresentation公司介绍PowerPointwithhardcopiesprovided提供幻灯片和复印件FDAwillhaveinitialquestionsandwillrequestessentialdocumentsFDA会提出初步问题，并要求一些必要的文件10RFLAssociatesFlowofthepre-ApprovalInspection/InitialMeeting

批准前检查的流程/首次会议TheCompanyPresentation(30-45minutes)公司介绍（30-45分钟）ImportanceoftheInitialPresentation

首次介绍的重要性ItisFDA’sfirstimpressionofyourcompany这是FDA对你们公司的第一印象Itshouldbeveryprofessional(graphicsandpresentation)必须非常专业（图表和介绍）ItshouldbeinEnglish必须是英文的Itshouldnotbetoolong(1houristoolong)

不能太长（1个小时太长）Youshouldrehearsegivingthepresentationtomakesureitisperfect你们应该排练一下介绍，要确保做到完美11RFLAssociatesFlowofthepre-ApprovalInspection/InitialMeeting

批准前检查的流程/首次会议TheCompanyPresentation(30-45minutes)公司介绍（30-45分钟）HistoryofBusiness历史Whenwasitfounded?Bywhom?

什么时候创建？谁创建？Importantmilestonesduringcompanydevelopment公司发展的重要里程碑Sitechanges

场地的变更Additionofbuildings,purchaseofmajorequipment

追加的建筑，关键设备的采购Productintroductions

产品介绍TotalNumberofemployeesattheinspectionsite,andinthefollowingdepartments:在检查工厂的员工总人数和下列部门的人数TopManagement高级管理层QualityAssuranceQAQualityControlQCProduction生产ResearchandDevelopment研发(Administrative)（行政）(FinancialandSales)（财务和销售）12RFLAssociatesFlowofthepre-ApprovalInspectionTheCompanyPresentation(30-45minutes)公司介绍（30-45分钟）AnnualSales(convertedtoUSDollars)年度销售（转化成美元）Certifications/AchievementsrelatingtoQuality(ISO,etc.)质量体系相关证书（ISO等）Introductiontoproducts产品介绍AllAPIsandalldosageforms所有的API和制剂剂型USandnon-USmarkets美国和非美国市场InspectionalHistory检查历史USFDASFDA(CustomerAudits)客户审计Other其他13RFLAssociatesFlowofthepre-ApprovalInspectionTheCompanyPresentation(30-45minutes)PlantLayout(PlanandPhotographs)

工厂布局图（规划图和照片）IndicatetheproductionareasthatFDAwillaudit说明FDA将要审计的生产区域Indicatewarehouseareas说明仓库区域IndicateQCLaboratorylocation说明QC实验室区域Givearea(squaremeters)ofeachworkshop,warehouse,QClaboratory给出每个车间，仓库，QC实验室的面积（平方米）14RFLAssociatesFlowofthepre-ApprovalInspectionTheCompanyPresentation(30-45minutes)OrganizationalChart组织机构图Companyasawhole整个公司的组织机构图QAOrganizationalChartQA组织机构图IntroductiontoQualitySystem介绍质量体系OverviewofManufacturingProcess

生产工艺过程概述15RFLAssociatesFlowofthepre-ApprovalInspection

WalkthroughofProductionandQCLaboratory(5-6hours)生产和QC实验室检查Warehouses仓库ProductionAreas生产区域CleanFinishingArea洁净区域PackagingandLabeling包装和贴签QCLaboratoryQC实验室Water,Air,Vacuum,PressureSystems水，空气，真空，压力系统16RFLAssociatesFlowofthepre-ApprovalInspectionDocumentsandRecordsReview(3-31/2days)文件和记录审核（3-3.5天）Intheconferencerooms在会议室Itisessentialtoretrieverequesteddocumentsquickly必须快速找到和提供要求的文件Itisessentialtohavetherightpeopleintheconferenceroomsattherighttime必须是对的人在对的时间在会议室里Donotovercrowdtheconferencerooms会议室不要过度拥挤Dohavethepersonbestqualifiedtoexplaineachdocument要让最好最有资历的人来解释每一个文件Domaintainasenseoforderandprofessionalism要维持有秩序和专业化，职业化的感觉17RFLAssociatesFlowofthepre-ApprovalInspectionFDAWillusuallygiveadailywrap-upFDA通常每天都会给出小结Endoftheday,15-30minutes在每天结束时，15-30分钟Issuesandconcernsfoundduringthedayarediscussed

在一天当中讨论过的问题和关注的事情LastDay:最后一天Closeout(1-1½hours)结束总结（1-1.5小时）Presentationof483bytheFDAteamFDA小组给出483说明Firm’sverbalresponsetothe483ispresented.公司对于483的口头回复Awritten483responseshouldbegiventoFDAwithin30daysofcloseout.Youshould书面的483回复应该在结束的30天之内提交给FDASetout,correctiveactionplanto483observations(withdocumentation)针对483不符合项，要作出准确的整改计划（文件）Youcanobjecttoobservationsthatyoufeelareincorrect(withdocumentation)你们可以反对不符合项，如果你们觉得不正确（文件）18RFLAssociatesGeneralConsiderationsEstablishWorkHoursandLunchTimesatbeginningofaudit在审计开始就要制定工作时间和午餐时间Lunchtimesgenerallyonehouratmost午餐时间一般最多为1小时Donothavelong,elaboratelunches不要太久，使午餐变复杂Bepreparedtoworkduringeveningsifneeded如果需要，准备好晚上工作DeliverRequestedDocumentsPromptlyandEfficiently!传递文件要全面，有效19RFLAssociatesGeneralConsiderationsDonotusearecordertotapetheinspection审计中不要使用录音机DonottakephotosduringtheinspectionwithoutFDA’spermission没有FDA的允许，在检查过程中不要拍照片Donotcarryoutloudside-discussionsduringtheinspection!在检查过程中不要在旁边大声讨论Duringthewalkthrough现场检查过程中Duringdocumentreview文件审核过程中20RFLAssociatesGeneralConsiderationsLoudside-discussions(inChinese)

在旁边大声讨论（用中文）AredistractingtotheFDA会让FDA官员分心Appearextremelyunprofessional显示极其不专业Givetheappearancethatthecompanyisnotprepared给人以公司没有做好准备的印象21RFLAssociatesGeneralConsiderationsAlwayskeepinMind:要时刻记着Thecompanyshouldalwaysappeartobeprofessional公司要表现出专业化Thecompanyshouldalwaysappeartobeprepared公司要表现出做好充分准备Thecompanyshouldalwaysworktomaketheinspectionrunsmoothlyandefficiently公司要要确保检查能够顺利有效第进行Theinvestigatorswillbehappiestifyoucanmaketheirjobseasy如果你们可以让他们的工作轻松，检察官会非常高兴22RFLAssociatesGeneralConsiderationsDecideyourcompany’spolicyonFDAtakingphotosbeforethePAI在检查前，确定出你们公司对于FDA是否可以拍照相关政策Youarenotrequiredtopermitthemtophotographyourfacility你们没有被要求你们必须允许FDA官员可以在你们公司拍照片However,youmaydecidetodothis但是你们可以做决定是不是允许Donotbringitup,butifitcomesup,makesurethatyouhaveaclearpolicy不要把这个事情单独提出来，但是如果出现，那么确保你们有一个明确的政策23RFLAssociatesGeneralConsiderationsDecidebeforetheinspectionyourcompany’spolicyonprovidingdocuments

在检查前，确定出你们公司对于是否提供文件的相关政策Ingeneral,youmustprovideallGMP-relateddocumentsrequested,butmarkthemas“Confidential”通常来说，你们必须提供检察官要求的全部与GMP相关的文件，但是要标明他们是“保密的”YoudonothavetoprovideinternalauditandselfinspectionresultstoFDA,butyoumaywishtodosoinsomecases你们不必要提供内审和自检结果给FDA，但是有时你们可能自己希望这么做24RFLAssociatesGeneralConsiderationsUnderstandFDA’sPolicyonMeals,HotelAccommodations,andGifts了解FDA关于吃饭、宾馆住宿和礼物的规定AtPresent,FDApaysformeals,hotelaccommodations目前，FDA支付吃饭和宾馆住宿的费用Askinspectorsabouttheirpreferencesforeveningmeals:询问检察官关于晚餐安排的意见Theymaywishtodinewiththecompany他们可能希望和公司一起吃晚饭Theymaywishtodinealone他们可能希望单独吃饭Askinspectorsabouttheirpreferencesonentertainmentafterhours询问检察官关于休闲时间娱乐活动意见Donotofferelaborategifts不要提供精心准备的复杂的礼物25RFLAssociatesTheImportanceoftheInterpreter翻译的重要性Interpretershouldbeveryprofessional翻译应该非常专业InterpretershouldrepresentFDAandbeneutral翻译应该代表FDA，必须中立Interpretershouldnotaddwordsorchangethemeaningofwords翻译不能增加文字或是改变文字含义ChinesetoEnglish中文翻译成英文EnglishtoChinese英文翻译成中文26RFLAssociatesTheImportanceoftheInterpreterInterpretermustbefamiliarwith:

翻译必须熟悉GMPterminologyGMP术语PharmaceuticalManufacturingterminology医药生产术语Chemicalnames(rawmaterials,intermediates,API,dosageforms)化学名词（原料，中间体，API，制剂剂型）LaboratoryInstrumentnames实验室仪器名称27RFLAssociatesPlanningandLogistics:计划和后勤DocumentStagingArea文件存放区EstablishaDocumentStagingArea准备一个文件存放区DocumentStagingAreaiswhereallplannedandanticipateddocumentsarestored文件存放区是指存放所有计划和预计要提供的文件的地方DocumentStagingAreaisneartheConferenceRooms文件存放区要靠近会议室DocumentStagingAreaisstockedwithdocumentsbeforetheinspection在检查之前文件存放区要放好文件28RFLAssociatesPlanningandLogistics:DocumentStagingAreaSeparateRoom,NearInvestigators要单独的房间，靠近检察官DocumentsArrangedandAvailable安排准备好文件PeopleAssignedtoRetrieveDocuments指定人员检索取文件Havedocumentsfiledsotheycanberetrievedinstantly文件要归档好，这样可以立即检索取出文件Haveaphotocopiereasilyavailable(andaback-up)准备好一个复印机（一个备用）29RFLAssociatesPlanningandLogistics:DocumentStagingAreaAllDocumentsrequestedbyFDAaretakenfromandreturnedtothisareaFDA要求的所有文件必须从这个房间取出，再放回到这个地方KeepalogofeachdocumentrequestedbyFDA

FDA要求的每一个文件都要有记录Documentname文件名称Requestdate/time要求的日期和时间Deliverydate/time提供的日期和时间IfFDArequestsacopyMake2copies:如果FDA要求复印件，那么就要准备好2份复印件1.ForFDA1份提供给FDABriefreview(byQA)beforereleasingit在提供之前要（QA）简单审核Stampitas“Confidential”or“UncontrolledCopy”敲上”保密”或是“不控制”章2.FortheCompanyInspectionalFile1份作为公司检查存档30RFLAssociatesPlanningandLogistics:计划和后勤CompanyInspectionalFile公司检查记录存档ContainsaRecordofnotestakenbythescribe包括记录员的记录ContainsaRecordofallemployeesinterviewedbyFDAInspectorsandthesubjectmatter包括FDA检察官面谈所有员工的记录和主题ContainsCopiesofalldocumentsgiventoFDAInspectors包括提供给FDA检察官的所有文件的复印件ContainsaRecordofanydiscussionswithFDAInspectors包括和FDA检察官讨论的所有内容记录Duringinspection检察过程中讨论内容Dailycloseouts每天总结讨论内容483closeout483总结时讨论内容ContainsaRecordofanycorrectionsmadeduringtheinspection包括在检查过程中做的所有整改工作的记录31RFLAssociatesPlanningandLogistics:TheScribe(s)计划和后勤：记录员Scribe(s):Takeswrittennotesduringthewalkthrough(andintheconferenceroom)记录员：在现场审计和文件审核过程中做书面记录TheScribeshouldtakeallnotesoftheinspection记录员应该记录所有检查的事项TheScriberecordsallFDArequestsfordocuments记录员应该记录FDA要求的所有文件32RFLAssociatesTheRunnersBeijing200833RFLAssociatesPlanningandLogistics:TheRunners计划和后勤：文件传送者Runners:Retrievedocumentsrequestedduringthewalkthrough(andduringdocumentreview)

文件传送者：在检查过程中取出要求的文件TheRunnersretrievetheDocumentsrequestedduringPlantTour,anddeliverthemtotheConferenceRoom在工厂参观期间，文件传送者要取出官员要求的文件，把文件送到会议室Documentsrequestedshouldbeavailableinconferenceroomwhenplanttouriscompleted当工厂参观结束时，FDA官员要求的文件必须已经在会议室QAshouldpresentthedocumentsrequestedassoonasFDAreturnstotheconferenceroom当FDA回到会议室时，QA应该马上提供要求的文件ShowFDAthedocumentsthatwererequested向FDA展示是他们要求的文件Thisgivesanexcellentimpressionofefficiencyandprofessionalism这会留下非常好的印象：有效率，专业化34RFLAssociatesFactoryTour工厂参观Warehouses仓库RawMaterial原料Solvents溶剂Intermediates中间体FinalProduct成品PackagingandLabeling包装和贴签Samplingroomsorareas取样室或区域Rejectedproductareas拒收产品区域35RFLAssociatesFactoryTourProductionAreas生产区域Frombeginningtoend从开始到结束Followingthemanufacturingprocess根据生产工艺Describethematerialflowandthepeopleflow

描述物流和人流Ifintermediatesaretransferred,explainhow(openorclosed):如果中间体转移，解释如何转移（开放系统还是密闭系统）Dischargethroughreactoroutlet(liquids)

通过反应釜出口排出（液体）Transferredtobins(wetcake,powders)

转移到容器中（湿的块状物，粉末）Pumpedthroughpiping(liquids)通过管道来泵压（液体）36RFLAssociatesFactoryTour/ProductionAreas

工厂参观/生产区域FDAmay,duringtheWarehouseandFactoryTourFDA可能在仓库和工厂参观中做以下事情：Askworkersquestions(jobknowledgeandGMPawareness)询问工人问题（工作知识和GMP意识）RequestQCTestrecordsforselectedlotsofmaterials

要求选择性批次物料的QC检测记录The‘runner’shouldretrievethesefromthestagingareaandhavethemreadyafterthetour文件传送者应该从文件存放区取出文件，在参观结束后准备好记录Examinebatchrecordsforin-processproduction检查生产记录Makesurestepsaresignedandwitnessedatthetimetheyareperformed

确保每一步生产时有签名，并有复核人RequestCleaningRecordsforequipment(forexamplelast6months)(Runner)要求设备的清洁记录（例如过去6个月记录）（文件传送者）RequestcopiesofMasterLabels(Runner)要求空白标签的复印件（文件传送者）MakesurethatSOPsarepresent确保SOP在现场37RFLAssociatesFactoryTour/QCLaboratory

工厂参观/QC实验室QCLaboratory:Prepareto…QC实验室：准备Explainpaperworkflowandrecords

解释文书工作流程和记录Requestsforsampling要求取样Samplingandreceivinglogbook取样和接收登记记录Howsamplesareassigned样品如何分配？Howtestdataisrecorded检测结果如何记录？Logbooks日志Worksheets工作表Reviewproceduresforcompletedwork

完成工作的审核程序IssuanceofCOACOA的发布38RFLAssociatesFactoryTour/QCLaboratory

工厂参观/QC实验室QCLaboratoryExplainSampleflow解释样品流程Incomingsamplestorage新进样品的存放Samplelabeling样品贴签Samplestorageduringanalysis样品在分析过程中的储存Reservesamplesstorage留样储存Sampledisposal样品处理39RFLAssociatesFactoryTour/QCLaboratory

工厂参观/QC实验室Makesurepeoplearebusyandinstrumentsareoperational确保实验室人员忙于工作，仪器在运行FDAmay,duringtheQCLaboratorytour:在QC实验室参观期间，FDA可能AskanalyststechnicalandGMPquestions(everyanalystshoulddemonstratejobknowledge)询问分析人员技术和GMP问题（每个热分析人员应该证明一定的工作知识技能）40RFLAssociatesFactoryTour:Peopletobepresent工厂参观/出席人员Limitto8-9peopleifpossible如果可以，人员限定8-9人FDAInspectors(2)FDA检查官（2个）Interpreter(1)翻译（1个）EssentialCompanyPersonnelonly必要的公司人员QApersonnel(limitednumber)QA（限定人数）ResponsibleSupervisorforthatpartoftour

被参观部门的负责主管Scribe(apersonwhorecordsnotes)记录员（1个记录）Twopeopletoretrieverequesteddocumentsforlater(Runners)2个稍后取文件的人（文件传送者）41RFLAssociatesFactory/LabTour:Peopletobepresent工厂参观/出席人员Warehouses仓库Warehousekeeperforthatwarehouse

仓库仓管员Materialssamplingperson(QCLaboratory:toexplainsamplingifsamplingdonebyQC)物料取样人员（QC实验室：如果取样是QC进行的，那么解释取样流程）QAperson,scribe,runnersQA人员，记录员，文件传送者42RFLAssociatesFactory/LabTour:Peopletobepresent工厂参观/出席人员ProductionAreas生产区域ProductionManagerforthatworkshop车间的生产经理Productionworkers(shouldbebusyandworking)

生产工人（必须忙于工作）IPCLaboratoryperson中控实验室人员QAperson,scribe,runnersQA人员，记录员，文件传送者43RFLAssociatesFactory/LabTour:Peopletobepresent工厂参观/出席人员CleanProductionArea洁净区LimitedAccess限制人员进入Planwhowillgoin(limitednumber)

计划谁进入洁净区（人数限定）Makesuregowningproceduresareclearlyindicated确保着装程序有清楚说明Makesureshoecoversandgownsarelargeenough(XXXL)确保鞋子和衣服足够大（XXXL）44RFLAssociatesFactory/LabTour:Peopletobepresent工厂参观/出席人员QCLaboratoryQC实验室QCLaboratoryManagerQC实验室经理QAPerson(s),Scribe,RunnersQA人员，记录员，文件传送者Makesureshoecoversandlabcoatsarelargeenough确保鞋子和实验室工作服足够大Analystsshouldbebusyandworking分析人员要忙于工作Instrumentsonandrunning仪器要开着并运行Showhowpaperworkishandledanddocumented显示文书工作怎么处理和存档Frombeginningtoend从开始到结束45RFLAssociatesAnsweringQuestions回答问题FDAwillinterviewproductionandQClabemployeesFDA将会面谈生产和QC实验室人员IfFDAinterviewsemployees,managementmustnotanswerfortheemployee如果FDA面谈职工，那么管理层不能替职工回答Employeesmustnotdiscussanswers(inChinese)withmanagementbeforeansweringquestions在回答问题之前，职工不能和管理人员（用中文）讨论怎么回答46RFLAssociatesAnsweringquestions(foremployees)回答问题（给职工）Listentothequestioncarefully,thenanswerthatquestiondirectly

仔细听问题，然后直接回答问题Donotansweradifferentquestionthanwasasked(listencarefullyandthenanswer)不要答非所问（先听清楚问题，再回答）Donotansweronlywith:“IfollowtheSOP”不要只回答“我根据SOP来做的”Youmustdemonstratejobknowledge你必须证明你的工作知识Donotpre-discussanswerswithotheremployeesorsupervisors不要和其他员工或是主管预先讨论答案AnswerdirectlytotheFDAperson:lookathim/her(nottheinterpreter,nottheboss)直接向FDA官员回答：看着官员（而不是看着翻译或是老板）47RFLAssociatesAnsweringquestions(foremployees)回答问题（给职工）IfFDAasksa“yesorno”question,answer“yes”or“no”first如果FDA询问的是一个“是或不是”的问题，那么首先回答“是”或“不是”Thenexplainfurtherifneeded

如果需要，再解释Ifyoudonotknowtheanswer如果你不知道答案(Forexample,ifthatisnotpartofyourjob)（例如，不是你的工作范围部分）Suggestthatapersoninanotherdepartmentcouldanswerthequestionmoreclearly建议其他部门的另一个人可以更清楚地回答这个问题Managementshouldthentakeover,andprovidetheanswerpromptly管理层应该接过这个问题，然后提供完整的回答48RFLAssociatesDocumentandRecordsReview

(3-3½Days)文件和记录审核（3-3.5天）HaveFollowingProductionRecordsAvailable(Goingbackaboutthreeyears)下列生产记录要能提供（追回到大概三年前）MasterandExecutedBatchRecords主生产记录和已执行的批生产记录CleaningRecords清洁记录QCLaboratoryTestRecordsQC实验室检测记录RawMaterialTesting原料检测In-ProcessTesting中控检测FinalReleaseTesting成品放行检测ReprocessedSolventTesting返工的溶剂检测MasterLabel(3copies)主标签（3份）49RFLAssociatesDocumentandRecordsReview

文件和记录审核HavefollowingLists/Tablesavailable(inEnglish)下列清单/目录要英文提供1.Tableofall

drugproducts,IntermediatesandAPI‘s

currentlymanufactured(regardlessof

intendedmarket)所有目前生产的药品，中间体和API的目录（不管市场）Product/APINameandCode产品/API名称和编号ActiveIngredient活性组分Countrieswheremarketed(USA,etc.)市场所在国家（美国等）USApplicationNumber(NDA,ANDA)andApplicationHolderName美国申请号（NDA,ANDA）和申请持有者名称ApplicationApprovalDate申请通过日期50RFLAssociatesDocumentandRecordsReview

文件和记录审核HavefollowingList/TablesAvailable(InEnglish)下列清单/目录要英文提供2.Listofalllots

manufactured

forthe

US

market

forthelast2yearstodateforallUSdrugproductsorAPIs过去两年到日前为止，为美国市场的药品或API生产的所有生产批次的清单DrugproductorAPInameandcode

药品或API名称和代号lotnumber批号Datemanufactured

生产日期Reworkedorreprocessed?(YorN)

重新加工或返工？（是或不是）lotstatusanddateoflaststatuschange批情况和最后状态的变更日期Approved,rejected,onhold批准，拒收，associateddeviationsorOOSinvestigations

相关的偏差或OOS调查51RFLAssociatesDocumentandRecordsReview

文件和记录审核HavefollowingLists/Tablesavailable(inEnglish)下列清单/目录要英文提供3.Listofalldrugproducts&APIsshippedtotheUSforthepast2yearstodate过去两年到日前为止，所有发到美国的药品和APIDrugProductorAPInameandcode

药品或API名称和编号lotnumber批号Datemanufactured生产日期Consignee&Location收货人和地址lotstatus批状态DateshippedtotheUS发货到美国的日期VolumeShipped发货量52RFLAssociatesDocumentandRecordsReview(List/Tables)文件和记录审核（清单/目录）4.Listofallcomplaintsforallproductsforthelastthreeyears过去3年全部产品的全部投诉清单Complaintnumber投诉编号APIorDrugproductAPI或药品LotNumber批号ShippedtoUS?(Y/N)发货到美国？（是或不是）ComplaintCloseoutdate投诉关闭日期HavecomplaintrecordsandalldocumentationavailableforreviewinDocumentStagingArea在文件存放区要确保可以拿到投诉记录和全部文件53RFLAssociatesDocumentandRecordsReview(List/Tables)文件和记录审核（清单/目录）5.List(inEnglish)ofallOutofSpecificationInvestigationsforthelastthreeyears过去3年全部OOS调查的清单（英文）OOSNumberOOS编号Material(RawMaterial,API,DrugProduct)物料（原料，API，药品）LotNumber批号LabError?(Y/N)实验室错误（是或不是）FinalDecisiononOOSOOS的最后决定OOSCloseoutDateOOS关闭日期HaveOOSrecordsandalldocumentationavailableforreviewinDocumentStagingArea在文件存放区要确保可以拿到OOS记录和全部文件54RFLAssociatesDocumentandRecordsReview

文件和记录审核HavefollowingLists/Tablesavailable(inEnglish)准备下列清单/目录（英文）MasterListofSOPsandSMPsSOP和SMP主清单SOPNumber,Title,VersionNumber,effectivedateSOP编号，名称，版本号，有效日期ListofProductionEquipmentforProductInspected被检查产品的生产设备清单EquipmentNumber,Name,Location设备号，名称，位置ListofQCLaboratoryInstrumentsforProductInspected被检查产品的QC仪器清单EquipmentName,Number设备号，名称Manufacturer,ModelNumber生产商，型号ListofApprovedVendorsforRawMaterials,Intermediates原料，中间体的合格供方清单55RFLAssociatesDocumentandRecordsReview

文件和记录审核HaveFollowingPlansandDrawingsAvailable下列设计图和图纸要准备PlantLayout工厂布局图IncludeAreas(SquareMeters)ofWorkshops包括车间的面积（平方米）IncludeArea(SquareMeters)ofQCLaboratory包括QC的面积（平方米）ShowMaterialFlowandPeopleFlow显示物流和人流PurifiedWaterSystem纯化水系统UpdatedPlans更新后的设计图ModificationHistory修改历史AirSystems(ProductionandCleanRooms)空气系统（生产和洁净室）UpdatedPlans更新后的设计图ModificationHistory修改历史OtherCriticalEngineeringDrawings(Vacuum,CompressedAir)

其他关键工程图纸（真空，压缩空气）Critical=Contactwithproduct关键=与产品接触56RFLAssociatesDocumentandRecordsReview

文件和记录审核HaveFollowingChartsAvailable下列图表要准备CorporateOrganizationalChart公司组织机构图ShowingNamesandTitles显示名字和职务Includethenameandtitleofthemostresponsiblepersonon-site包括现场主要责任人的名字和职务Shouldbepresentatbeginningandatthecloseout在首次和末次会议上要出席QualityUnitOrganizationalChart质量部门组织机构图ShowingNamesandTitles显示名字和职务ProcessFlowChart工艺流程图Includeallsteps包括所有步骤IncludeallequipmentwithequipmentID