准备FDA认证前检查中英文对照ppt课件

RichardNeedham,RFLAssociates,1,PreparingforFDAPreapprovalInspections准备FDA认证前检查,RichardNeedham,RFLAssociates,2,Purposeofapre-ApprovalInspection(DMForANDA)认证前检查的目的（DMF或ANDA）,Ensurethatthefacilities,equipment,andinstrumentsaresuitableforproducingaqualityproduct确保设施，设备和仪器适合高质量产品的生产Ensurethatthequalitysystemisfunctioningcorrectly确保质量体系运行正常EnsurethatproductismanufacturedundercGMPs确保在cGMPs指导下进行产品生产,RichardNeedham,RFLAssociates,3,Purposeofapre-ApprovalInspection认证前检验的目的,EnsurethatdatasubmittedintheANDAorDMFsubmissionissupportedbyrawdataatthefacility确保在ANDA或DMF文件中提交的数据以设施的原始数据为依据DataandoriginalrecordsmustbedocumentedaccordingtocGMPstandards原始数据和记录必须根据cGMP标准进行EnsurethattheANDAorDMFsubmissionisanaccuratereflectionofwhatisbeingdoneatthefacility确保ANDA或DMF中提交的是设施正在进行的情况的准确反应,RichardNeedham,RFLAssociates,4,ThePre-ApprovalInspection(PAI)认证前检查（PAI）,WhenistheDMFreviewedbyFDA?DMF什么时候被FDA审查？OnlyaftertheANDAholderfilestheANDAandreferstotheDMF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。However,theDMFholdershouldstillupdatetheDMFthroughannualreportsandDMFamendmentstotheFDA然而，DMF持有人仍应通过年度报告和DMF修订将更新提交给FDAThisway,theDMFwillbeup-to-datewhenreviewed这样，DMF被审查时将是最新的,RichardNeedham,RFLAssociates,5,ThePre-ApprovalInspection(PAI)认证前检查（PAI）,WhenistheANDAreviewedbyFDA?FDA什么时候审查ANDAAftertheANDAholderfilestheANDAANDA持有人将ANDA归档后Becauseofbacklogs,expectatleast6monthdelaybeforereviewing由于积压，预计至少延迟6个月才能被审查WhenistheInspectionscheduled?什么时候进行预先审查AftertheANDAissatisfactorilyreviewedANDA审查圆满后Deficiencylettermaybeissued信件缺乏可能成为问题Moreinformationmayberequested可能会要求更多的信息,RichardNeedham,RFLAssociates,6,Flowofthepre-ApprovalInspection认证前检查流程,FDAPersonnelInvolvedFDA涉及人员Twopeopleareusuallyinvolved:通常涉及两个人FDAInvestigator(Productionissues)FDA调查人员（生产问题）FDAChemist(LaboratoryIssues)FDA化验师（实验室问题）Generally,theywillworkseparately一般来说，他们将分开工作Therefore,preparationfortwopeopleisneeded因此，需要配备两个人,RichardNeedham,RFLAssociates,7,Flowofthepre-ApprovalInspection认证前检查流程,Preparationfortwopeoplegenerallymeans: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）Theinterpretersareextremelyimportanttothesmoothrunningoftheinspection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Investigator调查人员Chemist化验师,RichardNeedham,RFLAssociates,8,Flowofthepre-ApprovalInspection认证前检查,Inspectionwillusuallytake4fulldays检查通常需要4天InitialMeeting(1-1hours)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(2-2days)文件审查（2-2天半）Closeout(1-2hours)总结（1-2小时）However,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,RichardNeedham,RFLAssociates,9,Flowofthepre-ApprovalInspection认证前检查流程,InitialMeeting(1-11/2hours)首次会议（1-1个半小时）Introductionsandexchangeofbusinesscards介绍并交换名片Themostresponsiblepersonatthefirmshouldbepresent该公司负责人应该在场QA,Production,QCRepresentativesshouldbepresentQA，生产，QC代表应该在场,RichardNeedham,RFLAssociates,10,Flowofthepre-ApprovalInspection认证前检查流程,InitialMeeting(1-1hours)首次会议（1-1个半小时）Makesurethateverypersonisidentifiedbyn101ame确保每个人标注姓名Nameandtitledisplayedatinitialmeeting姓名和标题呈现在首次会议上Nametagsonuniformduringinspection检查期间所有姓名标签格式应统一Consideralsoahandoutwiththefollowinginformationforkeypeople:还考虑分发含有以下信息的资料给关键人员：Fullname(andEnglishsurnameifapplicable)全名（如果适用加上英文姓氏）Title标题Thumbnailphotograph照片缩图,RichardNeedham,RFLAssociates,11,Flowofthepre-ApprovalInspection认证前检查,InitialMeeting(1-1hours)首次会议（1-1个半小时）CompanyPresentation公司介绍PowerPointwithhardcopiesprovided提供可以拷贝的PPTFDAwillhaveinitialquestionsandwillrequestessentialdocumentsFDA会提出一些初始问题，并要求提供一些精炼的文档,RichardNeedham,RFLAssociates,12,Flowofthepre-ApprovalInspection/InitialMeeting认证前检查流程/首次会议,TheCompanyPresentation(30-45minutes)公司介绍（30-45分钟）ImportanceoftheInitialPresentation初始表现很重要ItisFDAsfirstimpressionofyourcompany这是FDA对该公司的第一印象Itshouldbeveryprofessional(graphicsandpresentation)应该很专业（图形和文稿）ItshouldbeinEnglish应当是英文的Itshouldnotbetoolong(1houristoolong)不应该过长（不超过1小时）Youshouldrehearsegivingthepresentationtomakesureitisperfec您应该提前演练您的演讲，保证他的完美,RichardNeedham,RFLAssociates,13,Flowofthepre-ApprovalInspection/InitialMeeting认证前检查流程/首次会议,TheCompanyPresentation(30-45minutes)公司介绍（30-45分钟）HistoryofBusiness企业历史Whenwasitfounded?Bywhom?什么时候成立？由谁创建？Importantmilestonesduringcompanydevelopment公司发展中的重要里程碑Sitechanges网站的变化Additionofbuildings,purchaseofmajorequipment此外还有建筑物，主要设备的采购Productintroductions产品介绍TotalNumberofemployeesattheinspectionsite,andinthefollowingdepartments:视察现场，以及以下部门的员工总数：TopManagement高层管理人员QualityAssuranceQAQualityControlQCProduction生产ResearchandDevelopment研发(Administrative)（行政）(FinancialandSales)（财务和销售）,RichardNeedham,RFLAssociates,14,Flowofthepre-ApprovalInspection认证前检查,TheCompanyPresentation(30-45minutes)公司介绍（30-45分钟）AnnualSales(convertedtoUSDollars)年销售额（换算成美元）Certifications/AchievementsrelatingtoQuality(ISO,etc.)认证/质量成果（ISO，等）Introductiontoproducts产品简介AllAPIsandalldosageformsproduceon-site所有API和所有剂型的生产现场USandnon-USmarkets美国和非美国市场销路InspectionalHistoryl查阅历史USFDAUSFDASFDA食品药品监督管理局OtherRegulatoryAgencies其他管理机构(CustomerAudits)（消费者协会）Other其他,RichardNeedham,RFLAssociates,15,Flowofthepre-ApprovalInspection认证前检查流程,TheCompanyPresentation(30-45minutes)公司介绍（30-45分钟）PlantLayout(PlanandPhotographs)工厂布局（平面图和照片）IndicatetheproductionareasthatFDAwillaudit说明FDA将审查的生产区域Indicatewarehouseareas请注明仓库区IndicateQCLaboratorylocation标明QC实验室位置Givearea(squaremeters)ofeachworkshop,warehouse,QClaboratory注明各车间，仓库，QC实验室面积（平方米）,RichardNeedham,RFLAssociates,16,Flowofthepre-ApprovalInspection认证前检查,TheCompanyPresentation(30-45minutes)公司介绍（30-45分钟）OrganizationalChart组织机构图Companyasawhole公司是一个整体QualityUnit(QAandQC)OrganizationalChart质量部门（QA和QC）的组织机构图IntroductiontoQualitySystem质量体系简介OverviewofManufacturingProcess制造工艺概述,RichardNeedham,RFLAssociates,17,Flowofthepre-ApprovalInspection认证前检查,WalkthroughofProductionandQCLaboratory(5-6hours)生产和QC实验室巡检（5-6小时）Warehouses仓库ProductionAreas生产区CleanFinishingArea洁净完成区PackagingandLabeling包装和标签QCLaboratoryQC实验室Water,Air,Vacuum,PressureSystems水，通风，真空，压力系统,RichardNeedham,RFLAssociates,18,Flowofthepre-ApprovalInspection认证前检查流程,DocumentsandRecordsReview(2-21/2days)文件和记录的审查（2-21/2天）Intheconferencerooms在会议室Itisessentialtoretrieverequesteddocumentsquickly迅速检索到要求的文件是至关重要的Itisessentialtohavetherightpeopleintheconferenceroomsattherighttime在适当的时间适当的人留在会议室是必要的Donotovercrowdtheconferencerooms会议室不要容纳太多人DonotcarryoutunnecessarysideconversationsinChinese不要用中文进行不必要的交谈Dohavethepersonbestqualifiedtoexplaineachdocument让最有资格的人来解释每个文档Domaintainasenseoforderandprofessionalism保持条理性和专业性,RichardNeedham,RFLAssociates,19,Flowofthepre-ApprovalInspection认证前检查,FDAWillusuallygiveadailywrap-upFDA通常会做每日总结Beproactiveandaskforoneduringtheinitialmeeting在首次会议上采取积极主动Endoftheday,15-30minutes总结一天的工作，15-30分钟Issuesandconcernsfoundduringthedayarediscussed讨论白天发现的问题和担忧Thisallowsthecompanytoassesshowtheinspectionisgoing这允许该公司评价检查进度Thisallowsthecompanytobeginpreparingcorrectionsorclearupmisunderstandings这允许该公司开始准备更正或澄清误解,RichardNeedham,RFLAssociates,20,Flowofthepre-ApprovalInspection认证前检查流程,Closeout(1-1hours)总结（1-1个半小时）Presentationof483bytheFDAteam美国FDA团队提出483Firmsverbalresponsetothe483ispresentedtothe483ispresented公司应口头答复提出的483Awritten483responseshouldbegiventoFDAwithin15daysofcloseout483书面答复应在工作结束后15天内上交给FDASetout,withdocumentation,correctiveactionplanto483observations列出更改483行动计划的意见，并列出依据Object,withdocumentation,toobservationsthatyoufeelareincorrect将你认为不正确的提出反对意见，并列出依据,RichardNeedham,RFLAssociates,21,Whatisthe483(FDA483)?什么是483（FDA的483）？,Aformonwhichinspectionalobservationsarewritten检查意见的一种书面形式Theyareobservations,notnecessarilydeficiencies他们提出的只是意见并不是缺陷Theyaregroupedunderthesixystemsheadings:它们归入sixystems体系：QualitySystem质量体系FacilitiesandEquipmentSystem设施和设备系统MaterialsSystem原料系统ProductionSystem生产系统PackagingandLabelingSystem包装和标签制度LaboratoryControlSystem实验室控制系统,RichardNeedham,RFLAssociates,22,TheFDAForm483FDA的483表格,Thecompanycandiscusstheobservationsverballyatcloseout在检查总结时该公司可以口头讨论检查Thecompanyshouldrespondinwritingwithin15daysofissuance该公司要在15日内发布书面答复The483,EstablishmentInspectionreport(EIR),andfirmsdocumentedresponsearereviewedbyFDAComplianceBranchFDA下属分支将检查设立检查报告（EIR），和公司有证据的回复的483材料Adecisionismadewhethertheinspectionis:作出决定检查是否是NAI(NoActionIndicated)NAI（无行动可能性）VAI(VoluntaryActionIndicated)VAI（无随意行动的可能性）OAI(OfficialActionIndicated)OAI（无官方行动的可能性）,RichardNeedham,RFLAssociates,23,GeneralConsiderations总则,EstablishWorkHoursandLunchTimesatbeginningofaudit在审计工作开始时确定工作时间和午餐时间Lunchtimesgenerallyonehouratmost午餐时间一般最多一小时Donothavelong,elaboratelunches午餐不要太长，太复杂Bepreparedtoworkduringeveningsifneeded如果有需要要在晚上做准备工作DeliverRequestedDocumentsPromptlyandEfficiently!迅速而高效地提供要求的文件！,RichardNeedham,RFLAssociates,24,GeneralConsiderations总则,Donotusearecordertotapetheinspection不要使用磁带录音机在检查中录音DonottakephotosduringtheinspectionwithoutFDAspermission亦不得在未经FDA的许可的情况下在检查过程中拍照Donotcarryoutloudside-discussionsduringtheinspection!不要在检查过程中大声进行多余的讨论Duringthewalkthrough在巡检过程中Duringdocumentreview在文件审查过程中,RichardNeedham,RFLAssociates,25,GeneralConsiderations一般考虑,Loudside-discussions大声私下讨论AredistractingtotheFDA会分散FDA注意力Appearextremelyunprofessional出现极不专业情况Givetheappearancethatthecompanyisnotprepared给予公司没有事先准备的期望,RichardNeedham,RFLAssociates,26,GeneralConsiderations一般考虑,AlwayskeepinMind:始终牢记Thecompanyshouldalwaysappeartobeprofessional该公司应始终表现出专业性Thecompanyshouldalwaysappeartobeprepared该公司应始终表现出有所准备Thecompanyshouldalwaysworktomaketheinspectionrunsmoothlyandefficiently公司应该尽可能保证检查工作顺利高效的进行Theinvestigatorswillbehappiestifyoucanmaketheirjobseasy如果你们能让检查员工作顺利他们将非常高兴,RichardNeedham,RFLAssociates,27,GeneralConsiderations一般考虑,DecideyourcompanyspolicyonFDAtakingphotosbeforethePAI在PAI之前在FDA发出的照片上决定公司的方针政策Youarenotrequiredtopermitthemtophotographyourfacility你不需要允许他们为设施设备拍照However,youmaydecidetodothis但是，您也可以决定这样做Donotbringitup,butifitcomesup,makesurethatyouhaveaclearpolicy不要提出，但是一旦提出，请确保你有一个明确的方针,RichardNeedham,RFLAssociates,28,GeneralConsiderations一般考虑,Decidebeforetheinspectionyourcompanyspolicyonprovidingdocuments在检查之前倘若有依据确定你的公司方针政策Ingeneral,youshould(must)providealldocumentsrequested,butmarkthemas“Confidential”一般情况下，你应该（必须）提供所有要求的文件，但标记为“机密”YoudonothavetoprovideinternalauditandselfinspectionresultstoFDA,butyoumaywishtodosoinsomecases您没有必要FDA审计和自查结果，但是你可能在某些个案里样做Toshowthatthecompanyiscommittedtoquality,andthecontinuousimprovementofquality表明公司致力于质量，质量不断提高,RichardNeedham,RFLAssociates,29,GeneralConsiderations一般考虑,UnderstandFDAsPolicyonMeals,HotelAccommodations,andGifts了解FDA关于餐饮，酒店住宿，及礼品的政策AtPresent,FDApaysformeals,hotelaccommodations目前，FDA支付餐饮，酒店住宿费用Askinspectorsabouttheirpreferencesforeveningmeals:询问检查员对晚餐的需求；Theymaywishtodinewiththecompany他们可能希望与该公司吃饭Theymaywishtodinealone他们可能想单独用餐Askinspectorsabouttheirpreferencesonentertainmentafterhours询问他们业余时间的娱乐项目Donotofferelaborategifts不赠予贵重的礼物,RichardNeedham,RFLAssociates,30,TheImportanceoftheInterpreter翻译员的重要性,Interpretershouldbeveryprofessional翻译员应该非常专业InterpretershouldrepresentFDAandbeneutral口译员应代表FDA并保持中立Interpretershouldnotaddwordsorchangethemeaningofwords口译员不应该增加词语或改变词语的意思ChinesetoEnglish汉语译成英语EnglishtoChinese英语译成中文,RichardNeedham,RFLAssociates,31,TheImportanceoftheInterpreter翻译员的重要性,Interpretermustbefamiliarwith:翻译员必须熟悉GMPterminologyGMP的术语PharmaceuticalManufacturingterminology制药业术语Chemicalnames(rawmaterials,intermediates,API,dosageforms)化学名称（原材料，中间体，空气污染指数，剂型）LaboratoryInstrumentnames实验室仪器名称,RichardNeedham,RFLAssociates,32,PlanningandLogistics:DocumentStagingArea规划和物流：文件临时存储区域,EstablishaDocumentStagingArea建立一个文件临时存储区域DocumentStagingAreaiswhereallplannedandanticipateddocumentsarestored文件临时存储区域存储所有计划和预期的文件DocumentStagingAreaisneartheConferenceRooms文件临时存储区域靠近会议室DocumentStagingAreaisstockedwithdocumentsbeforetheinspection文件临时存储区域保存备份文件,RichardNeedham,RFLAssociates,33,PlanningandLogistics:DocumentStagingArea规划和物流：文件临时存储区域,SeparateRoom,NearInvestigators单独的房间，靠近调查员DocumentsArrangedandAvailable文件有规划并且容易找到PeopleAssignedtoRetrieveDocuments专人负责文件检索Havedocumentsfiledsotheycanberetrievedinstantly将文件归档，需要时就可以立刻被找到Haveaphotocopiereasilyavailable(andabackupmachine)有一台可用的复印机(和备份机),RichardNeedham,RFLAssociates,34,PlanningandLogistics:DocumentStagingArea规划和物流：文件临时存储区域,AllDocumentsrequestedbyFDAaretakenfromandreturnedtothisareaFDA要求的所有文件均取自并返回这一区域KeepalogofeachdocumentrequestedbyFDAFDA要求的每一份文件形成一个记录Documentname文件名称Requestdate/time要求日期/时间Deliverydate/time送交日期/时间IfFDArequestsacopy,make2copies:如果FDA要求要副本，准备2份：1.ForFDA其中一份交给FDABriefreview(byQA)beforereleasingit在放出前由QA简要回顾一下Stampitas“Confidential”or“UncontrolledCopy”标记为“机密”或“可以复制”2.FortheCompanyInspectionalFile另一份由公司检查归档,RichardNeedham,RFLAssociates,35,PlanningandLogistics:CompanyInspectionalFile规划和物流：文件临时存储区域,ContainsaRecordofnotestakenbythescribe包含手抄记录ContainsaRecordofallemployeesinterviewedbyFDAInspectorsandthesubjectmatter包含了所有员工谈话和常见问题记录ContainsCopiesofalldocumentsgiventoFDAInspectors包含给FDA检查的所有文件副本ContainsaRecordofanydiscussionswithFDAInspectors包含FDA检察员的学术报告记录Duringinspection在检查过程中Dailycloseouts日常总结483closeout483总结ContainsaRecordofanycorrectionsmadeduringtheinspection包含视察期间作出的更正的记录,RichardNeedham,RFLAssociates,36,PlanningandLogistics:TheScribe(s)规划和物流：记录员,Scribe(s):TakesNotesduringthewalkthrough(andintheconferenceroom)记录员：在巡检过程中做记录（在会议室）TheScribe(s)shouldtakenotesoftheinspection记录员应在检查过程中做笔记TheScriberecordsallFDArequestsfordocuments记录员记录FDA对文件的要求,RichardNeedham,RFLAssociates,37,TheRunners,Beijing2008,RichardNeedham,RFLAssociates,38,PlanningandLogistics:TheRunners规划和物流：联络员,Runners:Retrievedocumentsrequestedduringthewalkthrough(andduringdocumentreview)联络员：检索在巡检过程中要求的文件（文件审查期间）TheRunnersretrievetheDocumentsrequestedduringPlantTour,anddeliverthemtotheConferenceRoom联络员检索在车间检查时要求的文件，并送到指定的会议室Documentsrequestedshouldbeavailableinconferenceroomwhenplanttouriscompleted在车间检查结束后在会议室应该可以找到要求的文件QAshouldpresentthedocumentsrequestedassoonasFDAreturnstotheconferenceroomQA应在FDA回到会议室前尽快提供要求的文件ShowFDAthedocumentsthatwererequested出示FDA要求的文件Thisgivesanexcellentimpressionofefficiencyandprofessionalism这将给人一种高效专业的印象,RichardNeedham,RFLAssociates,39,FactoryTour工厂检查,Warehouses仓库RawMaterial原料Solvents溶剂Intermediates中间体FinalProduct最终产品PackagingandLabeling包装和标签Samplingroomsorareas采样室或采样区Rejectedproductareas不合格产品区,RichardNeedham,RFLAssociates,40,FactoryTour工厂检查,ProductionAreas生产区Frombeginningtoend从开始到结束Followingthemanufacturingprocess按照制造流程Describethematerialflowandthepeopleflow标示出人流和物流Ifintermediatesaretransferred,explainhow(openorclosed):如果中间体转移，描画出具体的程序（打开或关闭）Dischargethroughreactoroutlet(liquids)出口释放（液体）Transferredtobins(wetcake,powders)转至储藏箱（湿滤饼，粉末）Pumpedthroughpiping(liquids)泵压管道（液体）,RichardNeedham,RFLAssociates,41,FactoryTour/ProductionAreas工厂检查/生产区,FDAmay,duringtheWarehouseandFactoryTourFDA可能在仓库和工厂参观Askworkersquestions(jobknowledgeandGMPawareness)询问工人问题（工作知识和GMP的认识）RequestQCTestrecordsforselectedlotsofmaterials要求QC考察记录大量的材料挑选Therunnershouldretrievethesefromthestagingareaandhavethemreadyafterthetour流动人员应从文件临时存储区域找到这些文件并在参观结束时准备好Examinebatchrecordsforin-processproduction审查生产进程的一组记录Makesurestepsaresignedandwitnessedatthetimetheyareperformed确保在执行过程中每个步骤都有签署有依据RequestCleaningRecordsforequipment(forexamplelast6months)(Runner)要求清空设备记录（例如，过去6个月）（流动人员）RequestcopiesofMasterLabels(Runner)要求复制主要的标记（流动人员）MakesurethatSOPsarepresent确保当前按标准操作程序进行,RichardNeedham,RFLAssociates,42,FactoryTour/QCLaboratory工厂检查/QC实验室,QCLaboratory:PreparetoQC实验室：准备Explainpaperworkflowandrecords解释文书记录工作流程Requestsforsampling请求抽样Samplingandreceivinglogbook采样和接收日志Howsamplesareassigned如何分配样本Howtestdataisrecorded如何记录测试数据Logbooks日志Worksheets工作表Reviewproceduresforcompletedwork审查已完成工作的程序IssuanceofCOACOA发布,RichardNeedham,RFLAssociates,43,FactoryTour/QCLaboratory工厂检查/QC实验室,QCLaboratoryQC实验室ExplainSampleflow说明样品处理流程Incomingsamplestorage来样存储Samplelabeling样品标签Samplestorageduringanalysis分析过程中样品储存Reservesamplesstorage留洋储存Sampledisposal样品清理,RichardNeedham,RFLAssociates,44,FactoryTour/QCLaboratory工厂检查/QC实验室,Makesurepeoplearebusyandinstrumentsareoperational确保员工有事可做，文件查阅方便FDAmay,duringtheQCLaboratorytour:FDA可能，在QC实验室参观过程中：AskanalyststechnicalandGMPquestions(everyanalystshoulddemonstratejobknowledge)询问专业化验师和GMP问题（每个化验师应表现出应有的工作知识）,RichardNeedham,RFLAssociates,45,FactoryTour:Peopletobepresent工厂检查：在场人员,Limitto8-9peopleifpossible如果可能的话限制为8-9人FDAInspectors(2)FDA检查员（2人）Interpreter(1)翻译员（1人）EssentialCompanyPersonnelonly公司只要基本人员即可QApersonnel(limitednumber)QA人员（数量有限）ResponsibleSupervisorforthatpartoftour负责主管参观部分的人员Scribe(apersonwhorecordsnotes)记录员（1个负责记录的人）Twopeopletoretrieverequesteddocumentsforlater(Runners)两个负责检索要求文件的人（联络员）,RichardNeedham,RFLAssociates,46,Factory/LabTour:Peopletobepresent工厂/实验室检查：在场人员,Warehouses仓库Warehousekeeperforthatwarehouse该仓库的仓库管理员Materialssamplingperson(QCLaboratory:toexplainsamplingifsamplingdonebyQC)材料取样人（QC实验室：解释抽样如果质控完成采样）QAperson,scribe,runnersQA人员，记录员，联络员,RichardNeedham,RFLAssociates,47,Factory/LabTour:Peopletobepresent工厂/实验室检查：在场人员,ProductionAreas生产区ProductionManagerforthatworkshop该车间的生产经理Productionworkers(shouldbebusyandworking)生产工人（应正在工作）IPCLaboratorypersonIPC实验室人员QAperson,scribe,runnersQA人员，记录员，联络员,RichardNeedham,RFLAssociates,48,Factory/LabTour:Peopletobepresent工厂/实验室检查：在场人员,CleanProductionArea洁净生产区LimitedAccess访问受限Planwhowillgoin(limitednumber)计划好谁将进入（数量有限）Makesuregowningproceduresareclearlyindicated确保着装程序，明确标示Makesureshoecoversandgownsarelargeenough(XXXL)确保鞋套和长跑足够大（XXXL）,RichardNeedham,RFLAssociates,49,Factory/LabTour:Peopletobepresent工厂/实验室检查：在场人员,QCLaboratoryQC实验室QCLaboratoryManagerQC实验室管理者QAPerson(s),Scribe,RunnersQA人员，记录员，联络员Makesureshoecoversandlabcoatsarelargeenough确保鞋套和实验服足够大Analystsshouldbebusyandworking分析师应忙于工作Instrumentsonandrunning仪器正在运行Showhowpaperworkishandledanddocumented显示如何记录和处理文件Frombeginningtoend从开始到结束,RichardNeedham,RFLAssociates,50,AnsweringQuestions回答问题,FDAwillinterviewproductionandQClabemployeesFDA将面试生产和QC实验室员工IfFDAinterviewsemployees,managementmustnotanswerfortheemployee如果FDA面试员工，管理层不能替员工回答Employeesmustnotdiscussanswers(inChinese)withmanagementbeforeansweringquestions员工不得在回答前用中文与管理层讨论答案,RichardNeedham,RFLAssociates,51,Answeringquestions(foremployees)回答问题（员工）,Listentothequestioncarefully,thenanswerthatquestiondirectly认真听问题，然后直接回答问题Donotansweradifferentquestionthanwasasked不要用