FieldAlertReport(FAR)–GuidanceforSubmissionStandardOperatingProcedure(SOP)andGuidelinetodescribetheprocessandrequirementstofileaFieldAlertReport(FAR)totheU.S.FoodandDrugAdministration(FDA)forproductsdistributed/marketedintheUnitedStates.標準操作程序（SOP）和指南，用于描述將在美國分銷/銷售產(chǎn)品的現(xiàn)場警報報告（FAR）提交給美國食品和藥物管理局（FDA）的過程和要求。SOPforFieldAlertReportSubmission現(xiàn)場警報報告提交SOP1.0 OBJECTIVE/目的ThisSOP/GuidelinedescribestheprocessandrequirementstofileaFieldAlertReport(FAR)totheU.S.FoodandDrugAdministration(FDA)forproductsdistributed/marketedintheUnitedStates.本SOP/指南描述了向美國食品和藥物管理局（FDA）提交現(xiàn)場警報報告（FAR）的流程和要求，用于在美國分銷/銷售的產(chǎn)品。2.0 SCOPE/范圍ThisSOP/Guidelineappliestothereportingrequirements,asoutlinedin21CFR314.81(b)(1)(i)(ii)NDAFieldAlertReport(FAR).

本SOP/指南適用于21CFR314.81(b)(1)(i)(ii)NDA現(xiàn)場警報報告(FAR)中概述的報告要求。ThisSOP/GuidelinedescribestheprocesstosubmitthecurrentFormFDA3331andanyothersubsequentcommunicationstotheFDAfordrugproductsdistributedtotheU.S.market.本SOP/指南描述了提交當前FDA3331表格的過程以及向FDA提交的任何其他后續(xù)通信，用于在美國市場分銷的產(chǎn)品。FieldAlertReport(FAR)shallbefiledifaqualityeventimpactstheidentity,safety,purity,andqualityoftheproduct,asdetailedin21CFR314.81(b)(1)(i)(ii).如果質量事件影響產(chǎn)品的特性、安全性、純度和質量，則應提交現(xiàn)場警報報告（FAR），詳見21CFR314.81(b)(1)(i)(ii)。FieldAlertReport(FAR)arerequiredtobesubmittedtotheUSFDA,forbothconfirmedorunconfirmedproblemsmeetingthedefinitionoftheregulationasdetailedbelow:現(xiàn)場警報報告(FAR)必須提交給美國FDA，對于符合法規(guī)定義的確認或未確認問題，詳述如下：Informationconcerninganyincidentthatcausesthedrugproductoritslabelingtobemistakenfor,orappliedto,anotherarticle.有關導致藥品或其標簽被誤認為或應用于另一物品的任何事件的信息。Informationconcerninganybacteriologicalcontamination,oranysignificantchemical,physicalorotherchangeordeteriorationinthedistributeddrugproductoranyfailureofoneormoredistributedbatchesofthedrugproducttomeetthespecificationestablishedforitintheapplication.有關任何細菌污染，或分銷藥品中任何顯著的化學、物理或其他變化或變質，或藥品的一個或多個分銷批次不符合申請中為其建立的規(guī)范的信息。ThisprocedureappliestodistributedNDAandANDAofProducts(includingthosemanufacturedatathird-partycontractmanufacturingsite)aswellasthoseproductsmarketedintheUnitedStates.此程序適用于已分發(fā)的NDA和ANDA產(chǎn)品（包括在第三方合同制造地點制造的產(chǎn)品）以及在美國。CompliancewiththisSOP/Guidelineismandatory,andthisSOP/Guidelineisapplicablegloballytoallcompany’sproductsmarketedtotheUSmarket.遵守本SOP/指南是強制性的，并且本SOP/指南在全球范圍內適用于所有公司向美國市場銷售的產(chǎn)品。EXCLUSIONS/排除:Research&Development(R&D)activitiesareexcludedfromthescopeofthisSOP/Guideline.研究與開發(fā)(R&D)活動不在本SOP/指南的范圍之內。TherequirementsforreportingBiologicalDeviationReports(BDPR)totheFDAareexcludedfromthescopeofthisSOP/Guideline.向FDA報告生物偏差報告（BDPR）的要求不在本SOP/指南的范圍內。RESPONSIBILITY–SUBMISSIONOFFIELDALERTREPORT:責任——提交現(xiàn)場警報報告：QualityAssuranceHeadshallberesponsiblefor:質量保證負責人應負責：Notifyingthe–Quality-AmericasoftheQualityeventwithinthe1stworkingday(Day-1)forevaluation/determinationofFieldAlertReport(FAR)applicability.在第一個工作日（第1天）將質量事件通知美國質量負責人，以評估/確定現(xiàn)場報警報告（FAR）的適用性。NotifyingHead-CorporateQualityCompliance(CQC)incasetheCAPAinitiatedforFieldAlertReport(FAR)investigationsmayhaveanyglobalimpact.通知公司質量合規(guī)(CQC)負責人，以防現(xiàn)場警報報告（FAR）調查發(fā)起的CAPA可能具有任何全球影響。Initiatingaformalinvestigation,byelectronicmeans(inTrackwiseoranequivalentsystem)orwherethemanualsystemisfollowed,

bythe3rdworkingday(Day-3)forRegulatoryHead–UStosubmittheinitialFieldAlertReport(FAR)totheFDA.通過電子方式（Trackwise或等效系統(tǒng)）或者遵循手動系統(tǒng)啟動正式調查，由美國法規(guī)負責人在第三個工作日（第3天）提交初始現(xiàn)場警報報告（FAR）給FDA。Implementingimmediateactionssuchasblockingaffectedbatches,makingarrangementfortheperformanceofspotchecks,立即采取行動，例如阻止受影響的批次，安排執(zhí)行抽查，ImplementinganyadditionalcontrolsrequiredinthewarehouseincaseswhereOOStestresultsorcomplaintinvestigationsmayimpacttheidentity,safety,purity,strength,andqualityoftheproduct.在OOS測試結果或投訴調查可能影響產(chǎn)品的特性、安全性、純度、強度和質量的情況下，實施倉庫所需的任何額外控制。IssuingQualityAlertsinatimelymannerforanycomplaint,investigation,orOOStestresultsthatmayimpacttheidentity,safety,purity,strength,andqualityoftheproduct,asdetailedin21CFR314.81(b)(1)(i)(ii).針對可能影響產(chǎn)品特性、安全性、純度、強度和質量的任何投訴、調查或OOS測試結果及時發(fā)布質量警報，詳見21CFR314.81(b)(1)(i)和(ii)。Investigating,testing,andresolvingQualityrelatedevents,andfortheevaluationandassessmentoftheimpactoftheseonotherbatchesand/orproducts.調查、測試和解決質量相關事件，以及評估和評估這些事件對其他批次和/或產(chǎn)品的影響。RegionalQualityHead–Americas/Designeeshallberesponsiblefor:美國區(qū)域質量負責人/指定人應負責：Receivingcommunicationfromthemanufacturingsites,suchastheinvestigation/deviationreports,stabilityresults,productcomplaints,etc.接收來自制造現(xiàn)場的溝通，例如調查/偏差報告、穩(wěn)定性結果、產(chǎn)品投訴等。EvaluationanddeterminationofFieldAlertReport(FAR)applicabilityunder21C.F.R.§314.81(b)(1)(i)and(ii)foranyapplicable/warrantedincidentasperthisstandard.根據(jù)21CFR§314.81(b)(1)(i)和(ii)評估和確定現(xiàn)場警報報告(FAR)適用性，適用于本標準的任何適用/保證事件。CommunicatingtheFieldAlertReport(FAR)submissiondecisiontakentotheHeadQualityandCompliance,RegulatoryHead,ManufacturingHead,andtheManagingDirector.將現(xiàn)場警報報告(FAR)提交決定傳達給質量和合規(guī)負責人、法規(guī)負責人、生產(chǎn)負責人和總經(jīng)理。GuidingthemanufacturingsiteandQualityteamstomeetHealthAuthorityexpectations.指導生產(chǎn)現(xiàn)場和質量團隊滿足衛(wèi)生當局的期望。HeadofQualityandCompliance/HeadOfManufacturing/RegulatoryHead/ManagingDirector(OrRespective

Designees)shallberesponsibleFor:質量與合規(guī)負責人/制造負責人/法規(guī)負責人/總經(jīng)理（或各自指定人員）應負責：ReviewingFieldAlertReport(FAR)inconjunctionwithotherrelevantstakeholders,requestingclarification,asneeded,andmakingrecommendationstoaddresstheissue.與其他相關利益相關者一起審查現(xiàn)場警報報告(FAR)，根據(jù)需要要求澄清，并提出解決問題的建議。ProvidingfeedbacktotheRegionalHeadofQuality–AmericasintheeventofanydisagreementwithRegionalHeads’decisiononFieldAlertReport(FAR).向美國區(qū)域質量負責人提供反饋，如果對區(qū)域負責人關于現(xiàn)場警報報告（FAR）的決定有任何異議。RecommendingSubjectMatterExperts(SMEs)tothesites.向現(xiàn)場推薦主題專家(SME)。Evaluatingthemulti-siteimpactoftheCAPAs,ifany,andmonitoringandtrackingtheprogressofthesame.評估CAPA的多站點影響（如果有），并監(jiān)控和跟蹤其進展。EnsuringthatproperhealthauthoritiesarenotifiedwithintherequiredtimeframeofareportableincidentrelatedtoaQualityAlertandthatinformationisavailabletoQualityAssurance,Drug/DeviceSafetySurveillance,andRegulatoryAffairs.確保在要求的時間范圍內將與質量警報相關的可報告事件通知適當?shù)男l(wèi)生當局，并且該信息可用于質量保證、藥物/器械安全監(jiān)督和法規(guī)事務。Distribution/WarehouseHeadorDesigneeshallberesponsiblefor:分銷/倉庫負責人或指定人員應負責：Placementofaffectedbatchesinaquarantineholdstatusuntiltheinvestigationiscompletedandadispositionhasbeenappliedtothequarantinedbatch.將受影響批次置于隔離保留狀態(tài)，直到調查完成并對隔離批次進行處置。RegulatoryAffairsHead–Us/Designeeshallberesponsiblefor:美國法規(guī)事務負責人/指定人員應負責：EvaluationanddeterminationofFieldAlertReport(FAR)applicabilityunder21C.F.R.§314.81(b)(1)(i)and(ii)foranyapplicable/warrantedincidentasperthisstandard.按照本標準，根據(jù)21CFR§314.81(b)(1)(i)和(ii)評估和確定現(xiàn)場警報報告（FAR）對任何適用/保證事件的適用性。Receivingcommunicationfromthemanufacturingsites,suchastheinvestigation/deviationreports,stabilityresults,productcomplaints,etc.接收來自制造現(xiàn)場的溝通，例如調查/偏差報告、穩(wěn)定性結果、產(chǎn)品投訴等。FilingaFieldAlertReport(FAR)withtheappropriateFDAdivisionandprovidinganysubsequentupdatesreceivedfromthemanufacturingsitestotheFDAAgencyfortheproduct(s)/batch(s)thathavebeendistributedtotheU.S.market.向相應的FDA部門提交現(xiàn)場警報報告(FAR)，并將從制造地點收到的任何后續(xù)更新提供給FDA機構，用于已分銷至美國市場的產(chǎn)品/批次。MaintainingFieldAlertReport(FAR)logforeachFARsubmittedtotheAgency.為提交給機構的每個FAR維護現(xiàn)場警報報告（FAR）日志。DrugSafety/Pharmacovigilance(PVG)/MedicalAffairsHeadorDesigneeshallberesponsibleFor:藥物安全/藥物警戒(PVG)/醫(yī)療事務負責人或指定人員應負責：Notificationofanymarketcomplaintthatmayimpactthe通知可能影響以下方面的任何市場投訴Identity,特性Safety,安全Purity,純度Strength,andqualityoftheproduct產(chǎn)品的規(guī)格和質量withinthe1stworkingday(Day-1)totheQualityHead-Americasand/orRegulatoryHead–USforevaluation/determinationofFieldAlertReport(FAR)applicability.在第一個工作日內（第1天）給美國質量負責人和/或法規(guī)負責人，以評估/確定現(xiàn)場警示報告（FAR）的適用性。PerformingHealthHazardEvaluation(HHE)assessmentifthequalityeventislife-threatening(deathhasorcouldoccur),permanentimpairmentofbodyfunctionorpermanentdamagerequiresmedicalorsurgicalintervention,temporaryorreversible(withoutmedicalintervention)oranyadversehealthconsequences.如果質量事件危及生命（已經(jīng)或可能發(fā)生死亡）、身體功能的永久性損害或永久性損害需要醫(yī)療或手術干預、臨時或可逆的（無需醫(yī)療干預）或任何不利的健康后果，則進行健康危害評估（HHE）。4.0 ABBREVIATIONSANDDEFINITIONS:縮寫和定義：ANDA–AbbreviatedNewDrugApplication/簡化新藥申請:AnapplicationforaU.S.genericdrugapprovalforanexistinglicensedmedicationorapproveddrug.申請現(xiàn)有許可藥方或批準藥品的美國仿制藥批準。API–ActivePharmaceuticalIngredient/活性藥物成分:Anysubstanceormixtureofsubstancesintendedtobeusedinthemanufactureofadrug(medicinal)productandthat,旨在用于制造藥物（醫(yī)藥）產(chǎn)品的任何物質或物質混合物，并且，Whenusedintheproductionofadrug,becomesanactiveingredientofthedrugproduct.當用于藥物生產(chǎn)時，成為藥物產(chǎn)品的活性成分。Suchsubstancesareintendedtofurnishpharmacologicalactivityorotherdirecteffectsinthediagnosis,cure,mitigation,treatment,orpreventionofdiseaseortoaffectthestructureorfunctionofthebody.此類物質旨在在疾病的診斷、治愈、緩解、治療或預防中提供藥理活性或其他直接作用，或影響身體的結構或功能。Assignable(Root)Cause/可分配（根本）原因:Theoriginorsourceofaqualityeventthathasbeenidentifiedtocausethedefect.已確定導致缺陷的質量事件的起因或來源。Themostbasicreason,whichifeliminated,wouldpreventarecurrence.最基本的原因，如果消除，將防止再次發(fā)生。ConfirmedEvent/確認事件:Dataorresultsgeneratedoutsideofthepre-establishedexpectedrangeoracceptancecriteriathatareinagreementwiththeoriginalresult.在預先建立的預期范圍或驗收標準之外生成的與原始結果一致的數(shù)據(jù)或結果。Aconfirmedeventshallbeinvestigated,documented,reviewed,andapprovedbythesiteQualityUnit.確認的事件應由現(xiàn)場質量部門調查、記錄、審查和批準。ControlledDocument/受控文件:Acontrolleddocumentisareferencedocumentthat,throughthecourseofitslifecyclemaybereviewed,modified,anddistributedseveraltimes.受控文件是一種參考文件，在其生命周期過程中可能會被多次審查、修改和分發(fā)。FieldAlertForm/現(xiàn)場警報表:AreportsubmittedtotheFDAoutlinedintheCodeofFederalRegulation314,Subpart314.81,documentedonFormFDA3331.提交給FDA的報告在《聯(lián)邦法規(guī)314》第314.81部分中概述，記錄在FDA3331表格中。HHE–HealthHazardEvaluation/健康危害評估:Anassessmenttoestablishthepotentialriskassociatedwiththeuseofaproductassociatedwithapotentialqualityevent.一項評估，以確定與潛在質量事件相關的產(chǎn)品使用相關的潛在風險。Notlimitedtoconsideringthepopulationatrisk,conditionsthatmayexacerbateorattenuatetheriskofoccurrence,andthelikelihoodoftheriskoccurringinthefuture.不限于考慮面臨風險的人群、可能加劇或減弱發(fā)生風險的條件以及未來發(fā)生風險的可能性。NDA–NewDrugApplication/新藥申請:TheNDAapplicationisthevehiclethroughwhichdrugsponsorsformallyproposethattheFDAapproveanewpharmaceuticalforsaleandmarketingintheU.S.NDA申請是藥物發(fā)明人正式提議FDA批準一種新藥物在美國銷售和上市的工具。Un-confirmedEvent/未確認事件:Originaldataorresultsthataregeneratedoutsideofthepre-establishedexpectedspecificationrangeoracceptancecriteria.在預先建立的預期規(guī)格范圍或驗收標準之外生成的原始數(shù)據(jù)或結果。Anon-confirmedqualityeventshallbeinvestigated,documented,reviewed,andapprovedbytheQualityUnit.未經(jīng)確認的質量事件應由質量部門調查、記錄、審查和批準。OOS-Out-of-Specification/不合格:Allresultsthatfalloutsidethepre-establishedspecificationsoracceptancecriteriaestablishedinthedrugapplication,drugmasterfiles,andofficialcompendiaorbythemanufacturer.超出在藥品申請、DMF和官方藥典中或制造商預先制定的質量標準或接受標準的所有結果。AnOOSshallbeinvestigated,documented,reviewed,andapprovedbythesiteQualityUnit.OOS應由現(xiàn)場質量部門調查、記錄、審查和批準。SignificantChange/重大變更:Achangethatcouldreasonablybeexpectedtoaffectthesafetyoreffectivenessoftheproduct.可以合理預期會影響產(chǎn)品安全性或有效性的變更。QualityAlert/質量警報:Generaldeficiencyinsystems,practices,orprocessesforGMP-QAareasthatadverselyaffect,對GMP-QA領域產(chǎn)生不利影響的系統(tǒng)、習慣或流程的一般缺陷，Thesafetyorwell-beingofpatientsorpublichealthand/orthequality,safety,andefficacyofmedicinalproductsand/orthatrepresentsignificantviolationsofapplicablelegislationandguidelineswhichmayneedtobeinformed/escalatedtoSeniorManagementofCompanyforinformation/supportinresolution.患者或公共衛(wèi)生的安全或福祉和/或醫(yī)藥產(chǎn)品的質量、安全性和有效性和/或嚴重違反適用法律和準則的行為，可能需要通知/上報公司高級管理層在決議時提供信息/支持。5.0 WORKFLOW–FIELDALERTREPORT:工作流程–現(xiàn)場警示報告：6.0 PROCESS–SUBMISSIONOFFIELDALERTREPORT:流程-現(xiàn)場警示報告的提交：FieldAlertReport(FAR)needstobefiledwheneverthemanufacturingsitegeneratesaqualityeventthatcomplieswiththeFARrequirements21CFR314.81(b)(1)(i)(ii).每當制造現(xiàn)場產(chǎn)生符合FAR要求21CFR314.81(b)(1)(i)(ii)的質量事件時，都需要提交現(xiàn)場警報報告(FAR)。ThetypesofqualityeventsrequiringFieldAlertsinclude,butarenotlimitedto:需要現(xiàn)場警報的質量事件類型包括但不限于：Anyincidentthatcausesthedrugproductoritslabelingtobemistakenfor,orappliedto,anotherarticle(Adulteratedormisbranded).Examplesinclude,butarenotlimitedto:任何導致藥品或其標簽被誤認為或應用于另一物品（摻假或貼錯標簽）的事件。示例包括但不限于：Labelingmix-uporerrors標簽混淆或錯誤Incorrectbottlelabel錯誤的瓶子標簽Incorrectinsert不正確的說明書Conflictinginformationonthelabelorinsert標簽或說明書上的沖突信息Anincorrectexpirationdatethatallowsaproducttobedistributedbeyonditsintendedexpirationdate.錯誤的失效日期導致產(chǎn)品在其預期失效日期之后分發(fā)。Foreignproduct國外產(chǎn)品Informationconcerninganybacterialcontamination.Examplesinclude,butarenotlimitedto:有關任何細菌污染的信息。示例包括但不限于：Reportedgrosscontamination報告的總污染Visiblemoldgrowth可見的霉菌生長Anysignificantchemical,physical,orotherchangeordeteriorationinthedistributeddrugproduct.Examplesinclude,butarenotlimitedto:經(jīng)銷藥品的任何顯著的化學、物理或其他變化或變質。示例包括但不限于：Significantspotsontablets片子上的顯著斑點Significantdiscolorationordecomposition明顯變色或分解Crumblingoftablets藥片破碎Precipitateinasolution溶液中的沉淀Hazardoussubstances,suchasglass,metal,strongforeignodor.有害物質，如玻璃、金屬、強烈的異味。Anyfailureofoneormoredistributedbatchesofthedrugproducttomeetthespecificationsestablishedforitintheapplication.Examplesinclude,butarenotlimitedto:任何一個或多個分銷批次的藥品未能滿足申請中為其制定的規(guī)范。示例包括但不限于：Anout-of-specificationresultgeneratedduringstabilityand/oraretainsample(reservesample)analysiswithintheproductexpirationperiod.產(chǎn)品有效期內穩(wěn)定性和/或留樣（reservesample）分析過程中產(chǎn)生的不合格結果。Wherebyretentionsampleexaminationresultsforanunexpireddistributedlotindicateanissuewithcontainer-closureintegrity,label/labeling,contamination,deterioration,orotherwisenotmeetingspecifications.因此，未過期分發(fā)批次的留樣檢查結果表明存在容器密閉完整性、標簽/標簽、污染、變質或其他不符合規(guī)格的問題。Customercomplaintswherepreliminaryinformationandinvestigationindicatethelikelihoodofanissuewiththebatchunrelatedtomishandlingbythecustomer.(RefertoSOPforMarketComplaints.)客戶投訴，其中初步信息和調查表明批次問題的可能性與客戶處理不當無關。（請參閱市場投訴SOP。）Deviations/Investigationsthatidentifyarootcauseandscopeofpotentialimpactimplicatingadistributedbatch.確定涉及分布式批次的潛在影響的根本原因和范圍的偏差/調查。ProcessofReportingtheInvestigation–FieldAlertReport:報告調查的過程-現(xiàn)場警示報告：TheQualityHeadshallcommunicateanyconcernsthatareidentifiedforimmediateconsiderationoffilingaFieldAlertReport(FAR)basedontheexamplesprovidedabovetotheHeadofQuality–Americasand/orRegulatoryHead–USwithinthe1stworkingday(Day-1)fortheirevaluation/determinationofFieldAlertReport(FAR)applicability.(ReferAttachment-II)質量負責人應當將被標識備案現(xiàn)場警示報告立即考慮任何問題（FAR）基于上面提供的質量頭部的例子-美洲和/或監(jiān)管頭-1內美日工作日（Day-1)以評估/確定現(xiàn)場警報報告(FAR)的適用性。（參考附件二）TheQualityHeadshallinitiateandconducttheirinvestigationfollowingtheproceduresdescribedintheSOPforInvestigations.質量負責人應按照調查SOP中描述的程序啟動和進行調查。Adescriptionoftheincidentandanypreliminaryinvestigation,supportingdocumentation,rootcause,correctiveandpreventativeactions,etc.事件描述和任何初步調查、支持文件、根本原因、糾正和預防措施等。Inaddition,theQualityHeadwillalsosubmittheinvestigationreportandCAPAstoCorporateCompliance.此外，質量主管還將向公司合規(guī)部提交調查報告和CAPA。CorporateComplianceshallreviewandevaluatethemulti-siteimpactofCAPAsandtakenecessaryactionsifapplicable.公司合規(guī)部門應審查和評估CAPA的多站點影響，并在適用時采取必要措施。ActionspriortoSubmissionofFieldAlertReport:提交現(xiàn)場警示報告之前的行動：Additionally,CorporateComplianceshallprovidethefeedbacktotheRegulatoryHead–theUS,ifany,beforeFieldAlertReport(FAR)submissions.(RefertoSOPforHandlingofCorrectiveandPreventiveActions-CAPA).此外，公司合規(guī)部應向監(jiān)管負責人提供反饋——我們，如果有，在現(xiàn)場警示報告(FAR)提交之前。（有關糾正和預防措施的處理，請參閱SOP-CAPA）。TheHeadofQuality-AmericasandtheRegulatoryHead–USwilldiscussandtakearisk-baseddecisiontoconcludetherecommendationforfieldalertreportingrequirement,i.e.,whethera

FieldAlertneedstobefiledunder21C.F.R.§314.81(b)(1)(i)and(ii).美洲質量主管和監(jiān)管主管–美國將討論并做出基于風險的決定，以得出對現(xiàn)場警示報告要求的建議，即是否需要根據(jù)21CFR§314.81(b)提交現(xiàn)場警報(1)(i)和(ii)。Subsequently,theRegionalHeadofQuality–AmericasshallcommunicatetheFieldAlertReport(FAR)submissiondecisiontaken(irrespectiveofwhetherFARisrecommendedornot)tothe隨后，美洲地區(qū)質量負責人應將現(xiàn)場警示報告（FAR）提交決定（無論是否推薦FAR）傳達給HeadQualityandCompliance,質量和合規(guī)負責人ManufacturingHead,生產(chǎn)負責人HeadRegulatoryAffairsand法規(guī)事務主管和TheManagingDirectorasearlyaspossiblewithinthe2ndworkingday(Day-2)keepingtheRegional/SiteQualityHeadintheloop.總經(jīng)理在第2個工作日（第2天）內盡早讓區(qū)域/現(xiàn)場質量負責人了解情況。ActionsafterconfirmationtoFilingofFieldAlertReport(FAR):確認提交現(xiàn)場警示報告(FAR)后的行動：OncenotifiedontheFieldAlertReport(FAR)submissiondecision,一旦接到現(xiàn)場警示報告(FAR)提交決定的通知，AllHeadsshallberesponsibleforsendingthefeedbacktotheHeadofQuality–Americaswithinthe3rdworkingday(Day-3),onlyintheeventofanydisagreementwiththeRegionalQualityHeads’FieldAlertReport(FAR)decision.所有負責人應負責向質量負責人發(fā)送反饋——美洲3內第三個工作日（第3天），僅與區(qū)域質量負責人現(xiàn)場警示報告（FAR）決定任何異議的情況下。TheFARssubmittedtotheFDAareclassifiedasInitial,Follow-up,orFinalreports.提交給FDA的FAR分為初始報告、跟蹤報告或最終報告。RegulatoryHead–US

shallnotifytheFDAbytelephone,bymailorotherrapidcommunicationwithinthree(3)workingdaysofthecompanybecomingawareofthereportedproblemoreventthatrequiresaFieldAlertReport(FAR),asdetailedin21CFR314.81(b)(1)(i)(ii)fortheInitialFAR.美國法規(guī)負責人應在公司獲悉需要現(xiàn)場警示報告（FAR）的報告問題或事件后3個工作日內通過電話、郵件或其他快速溝通方式通知FDA，詳見21CFR314.81(b)(1)(i)(ii)用于初始FAR。TheInitialFieldAlertReport(FAR)shallincludeanassessmentofthecauseoftheeventbasedontheinformationavailableatthetime.初始現(xiàn)場警示報告（FAR）應包括基于當時可用信息對事件原因的評估。IftheinitialrapidcommunicationdidnotincludetransmittaloftheinformationviathecurrentversionofFormFDA3331,theRegulatoryHead–US(ordesignee)willfollowuptheinitialcommunicationinwritingviasubmissionofFDAForm3331(referAttachment–II)totheFDADistrictOffice.如果初始快速溝通不包括通過當前版本的FDA3331表格傳輸信息，美國法規(guī)負責人（或指定人員）將通過提交FDA3331表格（參見附件–II）以書面形式跟進初始溝通)到FDA地區(qū)辦公室。CommitmentsmademustbedocumentedandtrackedtocompletionandmadeavailabletotheFDA,ifrequested.做出的承諾必須記錄在案并跟蹤完成，并在FDA要求時提供。Afollow-upFieldAlertReport(FAR)willbesubmittedbytheRegulatoryHead–UStotheFDAeverythirty(30)calendardaysuntiltheinvestigationiscompletedandtheFinalFARisfiled.后續(xù)現(xiàn)場警報報告（FAR）將由美國監(jiān)管負責人每三十(30)個日歷日提交給FDA，直到調查完成并提交最終FAR。Thefollow-upFARsshallidentifytheprogressmadeintheinvestigation.跟蹤FAR報告應確定調查取得的進展。TheFinalFieldAlertReport(FAR)willbesubmittedbyRegulatoryHead–UStotheFDA,notmorethanfive(5)workingdaysuponreceiptoftheconcluded(finalized)investigationreportfromthemanufacturingsites.最終現(xiàn)場警報報告(FAR)將由美國監(jiān)管負責人提交給FDA，在收到來自制造場所的最終（定稿）調查報告后的5個工作日內。Ifthereisanunforeseendelaythatisencounteredtosubmitthefinalreportwithinfive(5)workingdays,thisincidentshallalsobedocumentedintheFieldAlertFinalReport.如果在5個工作日內提交最終報告出現(xiàn)不可預見的延遲，該事件也應記錄在現(xiàn)場警報最終報告中。DrugSafety/Pharmacovigilance(PVG)/MedicalAffairsmayperformaHealthHazardEvaluation(HHE)toassesstheimpactofthequalityeventregardingtheidentity,safety,purity,strength,andqualityoftheproductforpatientsafety.藥物安全/藥物警戒（PVG）/醫(yī)療事務部可能會執(zhí)行健康危害評估（HHE），以評估質量事件對產(chǎn)品的特性、安全性、純度、強度和質量對患者安全的影響。IncludetheassessmentsummaryintheFieldAlertReport(FAR)correspondencetotheFDA,assubmittedbyRegulatoryAffairs.將評估摘要包含在監(jiān)管事務部提交給FDA的現(xiàn)場警示報告（FAR）信函中。TrackthecompletecycleofeventsintheFieldAlertReport(FAR)log(refertoattachment-III),maintainedbytheUSRegulatoryAffairs.AllFDAFiledAlertcommunicationsandlogthesubmissionsinthatlog.在美國監(jiān)管事務部維護的現(xiàn)場警示報告（FAR）日志（參見附件III）中跟蹤事件的完整周期。所有FDA提交的警報通信并在該日志中記錄提交。7.0 REQUIREMENTS–SUBMISSIONOFFIELDALERTREPORT:要求——提交現(xiàn)場警報報告：CompletingaFieldReportForm3331/填寫現(xiàn)場報告表3331:FARsinvolvingforeignfacilitiescanbereportedtothejurisdictionalFDAOffice,wherethefirm’sattorney,agent,orotherauthorizedofficialresidesormaintainsaplaceofbusinessintheU.S.涉及外國設施的FAR可以報告給具有管轄權的FDA辦公室，那里公司的的律師、代理人或其他授權官員在美國居住或維持營業(yè)地點。TheFieldAlertReport(FAR)formcontainsanexpirationdateinthetopleft-handcorneroftheform.EnsurethecurrentFDAForm3331isutilized.現(xiàn)場警報報告（FAR）表格在表格的左上角包含到期日期。確保使用現(xiàn)行的FDA表格3331。TheFDAwebsiteforFDAformsisfoundat/FDA表格的FDA網(wǎng)站位于/aboutfda/reportsmanualsforms/forms/listformsalphabetically/default.htmNote:Asanoption,theU.S.FDAhaslaunchedapilotprogramtoelectronicallysubmitFARSusingFormFDA3331A(Automated)toimprovethespeedandefficiencyofreportingqualityissuesrelatingtothemanufactureofFDA-approveddrugproducts.注意：作為一種選擇，美國FDA啟動了一項試點計劃，使用FDA3331A表格（自動）以電子方式提交FARS，以提高報告與FDA批準的藥品制造相關的質量問題的速度和效率。InstructionsareprovidedonlineforuseofForm3331A.

Fordetailsseeandenter3331A.在線提供使用表格3331A的說明。有關詳細信息，請訪問FDA網(wǎng)站并輸入3331A。FollowtheFieldAlertReport(FAR)instructionssuppliedinAttachmentII.按照附件II中提供的現(xiàn)場警報報告（FAR）說明進行操作。CompletetheelectronicFieldAlertReport(FAR)Form3331online,saveacopytoyourcomputer,andprinttwo(2)copiesoftheform.在線填寫電子現(xiàn)場警報報告（FAR）表格3331，將副本保存到您的計算機，然后打印2份表格副本。SubmitaseparatenarrativereportwithForm3331describingtheevent,summarizingtheinvestigation,andtheHealthHazardEvaluation,includinganycorrectiveactiontakenfortheaffectedproduct.提交一份單獨的敘述性報告和表格3331，描述事件、總結調查和健康危害評估，包括對受影響產(chǎn)品采取的任何糾正措施。FieldAlertReport(FAR)LOG/現(xiàn)場警報報告（FAR）日志:Thelogmaybeaboundbook,paginated,andproperlylabeledforitsintendedpurpose,oranelectronicversionofthesame,provideditismanagedasacontrolleddocument.(refertoattachment-III)日志可以是合訂本、分頁并根據(jù)其預期目的正確標記，或者是相同的電子版本，前提是它作為受控文件進行管理。（參考附件三）Thelogshallcontainthefollowingheadersattheminimum(butnotlimitedto):日志應至少包含以下標題（但不限于）：ProductName/Potency產(chǎn)品名稱/規(guī)格BatchNumber批號BatchManufacturingandExpiryDate批生產(chǎn)日期和有效期Packstyle包裝形式ANDA/NDCNo.ANDA/NDC編號ReferenceDocumentNumber參考文件編號ComplaintNumber/OOSNumber投訴編號/OOS編號ApplicationNumber申請?zhí)朚anufacturingSite生產(chǎn)地點FieldAlertReport(FAR)Description現(xiàn)場警報報告(FAR)說明ReceivingDate接收日期DatenotifiedtoFDA(Initial)通知FDA的日期（初始）DateofnotificationofFollow-upreport跟蹤報告通知日期FieldAlertReport(FAR)ReportType現(xiàn)場警報報告(FAR)報告類型Status狀態(tài)RetainallFDAFieldAlertcommunicationsandsubmissionsaspertherecordretentionprocedures.根據(jù)記錄保留程序保留所有FDA現(xiàn)場警報通信和提交。8.0 ATTACHMENTS–FIELDALERTREPORT(FAR):附件——現(xiàn)場警報報告：AttachmentI–ExampleTemplateofOOS/Deviation/IncidentNotificationForm附件一–OOS/偏差/事故通知表示例模板OOS/DeviationNo:OOS/偏差編號：Date:日期：Location:地點：From:

Regional/Location(Site)

HeadofQuality區(qū)域/位置（現(xiàn)場）質量負責人To:RegionalHeadofQuality–Americas

區(qū)域質量負責人–美洲OOS/Deviation/IncidentofthefollowingBatch(es)recommended:………………推薦以下批次的OOS/偏差/事故：S.No.編號Product產(chǎn)品BatchNumber批號ManufacturingDate生產(chǎn)日期ExpiryDate有效期至OOS/DeviationDetails:……………OOS/偏差詳情：AttachmentII–NDAFDAForm3331附件二–NDAFDA表格333