现场警报报告提交SOP.docx

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1、FieldAlertReport(FAR)-GuidanceforSubmissionStandardOperatingProcedure(SOP)andGuidelinetodescribetheprocessandrequirementstofileaFieldAlertReport(FAR)totheU.S.FoodandDrugAdministration(FDA)forproductsdistributed/marketedintheUnitedStates.标准操作程序(SOP)和指南，用于描述将在美国分销/销售产品的现场警报报告(FAR)提交给美国食品和药物管理局(FDA)的过程

2、和要求。SOPforFieldAlertReportSubmission现场警报报告提交SOP1.0OBJECTIVE/目的oThisSOP/GuidelinedescribestheprocessandrequirementstofileaFieldAlertReport(FAR)totheU.S.FoodandDrugAdministration(FDA)forproductsdistributed/marketedintheUnitedStates.o本SOP/指南描述了向美国食品和药物管理局(FDA)提交现场警报报告(FAR)的流程和要求，用于在美国分销/销售的产品。2.0SCoPE/

3、范围oThisSOP/Guidelineappliestothereportingrequirements,asoutlinedin21CFR314.81(b)(l)(i)(ii)NDAFieldAlertReport(FAR).o本SOP/指南适用于21CFR314.81(b)(l)(i)(ii)NDA现场警报报告(FAR)中概述的报告要求。oThisSOP/GuidelinedescribestheprocesstosubmitthecurrentFormFDA3331andanyothersubsequentcommunicationstotheFDAfordrugproductsdis

4、tributedtotheU.S.market.o本SOP/指南描述了提交当前FDA3331表格的过程以及向FDA提交的任何其他后续通信，用于在美国市场分销的产品。oFieldAlertReport(FAR)shallbefiledifaqualityeventimpactstheidentity,safety,purity,andqualityoftheproduct,asdetailedin2ICFR314.81(b)(l)(i)(ii).o如果质量事件影响产品的特性、安全性、纯度和质量，则应提交现场警报报告(FAR),详见21CFR314.81(b)(l)(i)(ii)。oFieldAl

5、ertReport(FAR)arerequiredtobesubmittedtotheUSFDA,forbothconfirmedorunconfirmedproblemsmeetingthedefinitionoftheregulationasdetailedbelow:o现场警报报告(FAR)必须提交给美国FDA,对于符合法规定义的确认或未确认问题，详述如下： Informationconcerninganyincidentthatcausesthedrugproductoritslabelingtobemistakenfor,orappliedto,anotherarticle. 有关导

6、致药品或其标签被误认为或应用于另一物品的任何事件的信息。 Informationconcerninganybacteriologicalcontamination,oranysignificantchemical,physicalorotherchangeordeteriorationinthedistributeddrugproductoranyfailureofoneormoredistributedbatchesofthedrugproducttomeetthespecificationestablishedforitintheapplication. 有关任何细菌污染，或分销药品中任何

7、显着的化学、物理或其他变化或变质，或药品的一个或多个分销批次不符合申请中为其建立的规范的信息。oThisprocedureappliestodistributedNDAandANDAofProducts(includingthosemanufacturedatathird-partycontractmanufacturingsite)aswellasthoseproductsmarketedintheUnitedStates.o此程序适用于已分发的NDA和ANDA产品(包括在第三方合同制造地点制造的产品)以及在美国。oCompliancewiththisSOP/Guidelineismanda

8、tory,andthisSOP/GuidelineisapplicablegloballytoallcompanysproductsmarketedtotheUSmarket.o遵守本SOP/指南是强制性的，并且本SOP/指南在全球范围内适用于所有公司向美国市场销售的产品。oEXCLUSlONS/排除：oResearch&Development(R&D)activitiesareexcludedfromthescopeofthisSOP/Guideline.o研究与开发(R&D)活动不在本SOP/指南的范围之内。oTherequirementsforreportingBiologicalDev

9、iationReports(BDPR)totheFDAareexcludedfromthescopeofthisSOP/Guideline.o向FDA报告生物偏差报告(BDPR)的要求不在本SOP/指南的范围内。3.0RESPONSIBILITY-SUBMISSIONOFFIELDALERTREPORT:责任提交现场警报报告：oQualityAssuranceHeadshallberesponsiblefor:o质量保证负责人应负责：oNotifyingthe-QUality-AmericasoftheQualityeventwithintheIs,workingday(Day-I)forev

10、aluation/determinationofFieldAlertReport(FAR)applicability.o在第一个工作日(第1天)将质量事件通知美国质量负责人，以评估/确定现场报警报告(FAR)的适用性。oNotifyingHead-CorporateQualityCompliance(CQC)incasetheCAPAinitiatedforFieldAlertReport(FAR)investigationsmayhaveanyglobalimpact.o通知公司质量合规(CQC)负责人，以防现场警报报告(FAR)调查发起的CAPA可能具有任何全球影响。oInitiating

11、aformalinvestigation,byelectronicmeans(inTrackwiseoranequivalentsystem)orwherethemanualsystemisfollowed,bythe3rdworkingday(Day-3)forRegulatoryHead-UStosubmittheinitialFieldAlertReport(FAR)totheFDA.O通过电子方式(TraCkWiSe或等效系统)或者遵循手动系统启动正式调查，由美国法规负责人在第三个工作日(第3天)提交初始现场警报报告(FAR)给FDA。oImplementingimmediateact

12、ionssuchasblockingaffectedbatches,makingarrangementfortheperformanceofspotchecks,o立即采取行动，例如阻止受影响的批次，安排执行抽查，oImplementinganyadditionalcontrolsrequiredinthewarehouseincaseswhereOoSIeSlresuksorcomplaintinvestigationsmayimpacttheidentity,safety,purity,strength,andqualityoftheproduct.o在OoS测试结果或投诉调查可能影响产品

13、的特性、安全性、纯度、强度和质量的情况下，实施仓库所需的任何额外控制。oIssuingQualityAlertsinatimelymannerforanycomplaint,investigation,orOOStestresultsthatmayimpacttheidentity,safety,purity,strength,andqualityoftheproduct,asdetailedin21CFR314.81(b)(l)(i)(ii).o针对可能影响产品特性、安全性、纯度、强度和质量的任何投诉、调查或OoS测试结果及时发布质量警报，详见21CFR314.81(b)(1)和(ii)。o

14、Investigating,testing,andresolvingQualityrelatedevents,andfortheevaluationandassessmentoftheimpactoftheseonotherbatchesand/orproducts.o调查、测试和解决质量相关事件，以及评估和评估这些事件对其他批次和/或产品的影响。oRegionalQualityHead-Americas/Designeeshallberesponsiblefor:O美国区域质量负责人/指定人应负责：oReceivingcommunicationfromthemanufacturingsite

15、s,suchastheinvestigation/deviationreports,stabilityresults,productcomplaints,etc.o接收来自制造现场的沟通，例如调查/偏差报告、稳定性结果、产品投诉等。oEvaluationanddeterminationofFieldAlertReport(FAR)applicabilityunder21C.F.R.314.81(b)(l)(i)and(ii)foranyapplicable/warrantedincidentasperthisstandard.o根据21CFR314.8I(b)(l)(i)和(ii)评估和确定现

16、场警报报告(FAR)适用性，适用于本标准的任何适用/保证事件。oCommunicatingtheFieldAlertReport(FAR)submissiondecisiontakentotheHeadQualityandCompliance,RegulatoryHead,ManufacturingHead,andtheManagingDirector.o将现场警报报告(FAR)提交决定传达给质量和合规负责人、法规负责人、生产负责人和总经理。oGuidingthemanufacturingsiteandQualityteamstomeetHealthAuthorityexpectations.

17、o指导生产现场和质量团队满足卫生当局的期望。oHeadofQualityandCompliance/HeadOfManufacturing/RegulatoryHead/ManagingDirector(OrRespectiveDesignees)shallberesponsibleFor:O质量与合规负责人/制造负责人/法规负责人/总经理(或各自指定人员)应负责：oReviewingFieldAlertReport(FAR)inconjunctionwithotherrelevantstakeholders,requestingclarification,asneeded,andmaking

18、recommendationstoaddresstheissue.o与其他相关利益相关者一起审查现场警报报告(FAR),根据需要要求澄清，并提出解决问题的建议。oProvidingfeedbacktotheRegionalHeadofQuality-AmericasintheeventofanydisagreementwithRegionalHeads,decisiononFieldAlertReport(FAR).o向美国区域质量负责人提供反馈，如果对区域负责人关于现场警报报告(FAR)的决定有任何异议。oRecommendingSubjectMatterExperts(SMEs)tothe

19、sites.o向现场推荐主题专家(SME)。oEvaluatingthemulti-siteimpactoftheCAPAs,ifany,andmonitoringandtrackingtheprogressofthesame.o评估CAPA的多站点影响(如果有)，并监控和跟踪其进展。oEnsuringthatproperhealthauthoritiesarenotifiedwithintherequiredtimeframeofareportableincidentrelatedtoaQualityAlertandthatinformationisavailabletoQualityAss

20、urance,Drug/DeviceSafetySurveillance,andRegulatoryAffairs.o确保在要求的时间范围内将与质量警报相关的可报告事件通知适当的卫生当局，并且该信息可用于质量保证、药物/器械安全监督和法规事务。oDistribution/WarehouseHeadorDesigneeshallberesponsiblefor:O分销/仓库负责人或指定人员应负责：oPlacementofaffectedbatchesinaquarantineholdstatusuntiltheinvestigationiscompletedandadispositionhasb

21、eenappliedtothequarantinedbatch.o将受影响批次置于隔离保留状态，直到调查完成并对隔离批次进行处置。oRegulatoryAffairsHead-Us/Designeeshallberesponsiblefor:O美国法规事务负责人/指定人员应负责：oEvaluationanddeterminationofFieldAlertReport(FAR)applicabilityunder21C.F.R.314.81(b)(l)(i)and(ii)foranyapplicable/warrantedincidentasperthisstandard.o按照本标准，根据2

22、1CFR314.81(b)(l)(i)和(ii)评估和确定现场警报报告(FAR)对任何适用/保证事件的适用性。Receivingcommunicationfromthemanufacturingsites,suchastheinvestigation/deviationreports,stabilityresults,productcomplaints,etc.接收来自制造现场的沟通，例如调查/偏差报告、稳定性结果、产品投诉等。oFilingaFieldAlertReport(FAR)withtheappropriateFDAdivisionandprovidinganysubsequentu

23、pdatesreceivedfromthemanufacturingsitestotheFDAAgencyfortheproduct(s)batch(s)thathavebeendistributedtotheU.S.market.o向相应的FDA部门提交现场警报报告(FAR),并将从制造地点收到的任何后续更新提供给FDA机构，用于已分销至美国市场的产品/批次。oMaintainingFieldAlertReport(FAR)logforeachFARsubmittedtotheAgency.o为提交给机构的每个FAR维护现场警报报告(FAR)日志。oDrugSafety/Pharmacovi

24、gilance(PVG)/MedicalAffairsHeadorDesigneeshallberesponsibleFor:O药物安全感物警戒(PVG)/医疗事务负责人或指定人员应负责：oNotificationofanymarketcomplaintthatmayimpacttheo通知可能影响以下方面的任何市场投诉 Identity,特性 Safety,安全 Purity,纯度 Strength,andqualityoftheproduct产品的规格和质量owithinthemworkingday(Day-I)totheQualityHead-Americasand/orRegulato

25、ryHead-USforevaluation/determinationofFieldAlertReport(FAR)applicability.o在第一个工作日内(第1天)给美国质量负责人和/或法规负责人，以评估/确定现场警示报告(FAR)的适用性。oPerformingHealthHazardEvaluation(HHE)assessmentifthequalityeventislifethreatening(deathhasorcouldoccur),permanentimpairmentofbodyfunctionorpermanentdamagerequiresmedicalorsu

26、rgicalintervention,temporaryorreversible(withoutmedicalintervention)oranyadversehealthconsequences.o如果质量事件危及生命(己经或可能发生死亡)、身体功能的永久性损害或永久性损害需要医疗或手术干预、临时或可逆的(无需医疗干预)或任何不利的健康后果，则进行健康危害评估(HHE)。4.0ABBREVIATIONSANDDEFINITIONS:缩写和定义：oANDA-AbbreviatedNewDrugApplication/简化新药申请：oAnapplicationforaU.S.genericdru

27、gapprovalforanexistinglicensedmedicationorapproveddrug.o申请现有许可药方或批准药品的美国仿制药批准。oAPI-ActivePharmaceuticalIngredient/活性药物成分：oAnysubstanceormixtureofsubstancesintendedtobeusedinthemanufactureofadrug(medicinal)productandthat,o旨在用于制造药物(医药)产品的任何物质或物质混合物，并且，oWhenusedintheproductionofadrug,becomesanactiveing

28、redientofthedrugproduct.o当用于药物生产时，成为药物产品的活性成分。oSuchsubstancesareintendedtofurnishpharmacologicalactivityorotherdirecteffectsinthediagnosis,cure,mitigation,treatment,orpreventionofdiseaseortoaffectthestructureorfunctionofthebody.o此类物质旨在在疾病的诊断、治愈、缓解、治疗或预防中提供药理活性或其他直接作用，或影响身体的结构或功能。oASSignable(RoOt)Cau

29、se/可分配(根本)原因：oTheoriginorsourceofaqualityeventthathasbeenidentifiedtocausethedefect.o已确定导致缺陷的质量事件的起因或来源。oThemostbasicreason,whichifeliminated,wouldpreventarecurrence.o最基本的原因，如果消除，将防止再次发生。oConfirmedEvent/确认事件：oDataorresultsgeneratedoutsideofthepre-establishedexpectedrangeoracceptancecriteriathatarein

30、agreementwiththeoriginalresult.o在预先建立的预期范围或验收标准之外生成的与原始结果一致的数据或结果。oAconfirmedeventshallbeinvestigated,documented,reviewed,andapprovedbythesiteQualityUnit.o确认的事件应由现场质量部门调查、记录、审查和批准。oControlledDocument/受控文件：oAcontrolleddocumentisareferencedocumentthat,throughthecourseofitslifecyclemaybereviewed,modifi

31、ed,anddistributedseveraltimes.o受控文件是一种参考文件，在其生命周期过程中可能会被多次审查、修改和分发。oFieldAlertForm/现场警报表：oAreportsubmittedtotheFDAoutlinedintheCodeofFederalRegulation314,Subpart314.81,documentedonFormFDA3331.o提交给FDA的报告在联邦法规314第314.81部分中概述，记录在FDA3331表格中。oHHE-HealthHazardEvaluation/健康危害评估:oAnassessmenttoestablishthep

32、otentialriskassociatedwiththeuseofaproductassociatedwithapotentialqualityevent.o一项评估，以确定与潜在质量事件相关的产品使用相关的潜在风险。oNotlimitedtoconsideringthepopulationatrisk,conditionsthatmayexacerbateorattenuatetheriskofoccurrence,andthelikelihoodoftheriskoccurringinthefuture.o不限于考虑面临风险的人群、可能加剧或减弱发生风险的条件以及未来发生风险的可能性。o

33、NDA-NewDrugApplication/新药申请：oTheNDAapplicationisthevehiclethroughwhichdrugsponsorsformallyproposethattheFDAapproveanewpharmaceuticalforsaleandmarketingintheU.S.oNDA申请是药物发明人正式提议FDA批准一种新药物在美国销售和上市的工具。oUn-confirmedEvent/未确认事件：oOriginaldataorresultsthataregeneratedoutsideofthepre-establishedexpectedspec

34、ificationrangeoracceptancecriteria.o在预先建立的预期规格范围或验收标准之外生成的原始数据或结果。oAnon-confirmedqualityeventshallbeinvestigated,documented,reviewed,andapprovedbytheQualityUnit.o未经确认的质量事件应由质量部门调查、记录、审查和批准。oOOS-Out-of-Specification/不合格：oAllresultsthatfalloutsidethepre-establishedspecificationsoracceptancecriteriaest

35、ablishedinthedrugapplication,drugmasterfiles,andofficialcompendiaorbythemanufacturer.o超出在药品申请、DMF和官方药典中或制造商预先制定的质量标准或接受标准的所有结果。oAnOOSshallbeinvestigated,documented,reviewed,andapprovedbythesiteQualityUnit.OOOS应由现场质量部门调查、记录、审查和批准。oSignificantChange/重大变更：oAchangethatcouldreasonablybeexpectedtoaffectth

36、esafetyoreffectivenessoftheproduct.o可以合理预期会影响产品安全性或有效性的变更。oQualityAlert/质量警报：oGeneraldeficiencyinsystems,practices,orprocessesforGMP-QAareasthatadverselyaffect,o对GMP-QA领域产生不利影响的系统、习惯或流程的一般缺陷，oThesafetyorwell-beingofpatientsorpublichealthand/orthequality,safety,andefficacyofmedicinalproductsand/ortha

37、trepresentsignificantviolationsofapplicablelegislationandguidelineswhichmayneedtobeinformed/escalatedtoSeniorManagementofCompanyforinfrmationsupportinresolution.o患者或公共卫生的安全或福祉和/或医药产品的质量、安全性和有效性和/或严重违反适用法律和准则的行为，可能需要通知/上报公司高级管理层在决议时提供信息/支持。5.0WORKFLOW-FIELDALERTREPORT:工作流程-现场警示报告:6.0PROCESS-SUBMISSIO

38、NOFFIELDALERTREPORT:流程现场警示报告的提交:oFieldAlertReport(FAR)needstobefiledwheneverthemanufacturingsitegeneratesaqualityeventthatcomplieswiththeFARrequirements21CFR314.81(b)(l)(i)(ii).o每当制造现场产生符合FAR要求21CFR314.81(b)(l)(i)(ii)的质量事件时，都需要提交现场警报报告(FAR)ooThetypesofqualityeventsrequiringFieldAlertsinclude,butaren

39、otlimitedto:O需要现场警报的质量事件类型包括但不限于：Anyincidentthatcausesthedrugproductoritslabelingtobemistakenfor,orappliedto,anotherarticle(Adulteratedormisbranded).Examplesinclude,butarenotlimitedto: -任何导致药品或其标签被误认为或应用于另一物品(掺假或贴错标签)的事件。示例包括但不限于： 1.abelingmix-uporerrors标签混淆或错误 InCotTeetbOtHeIabeI错误的瓶子标签 Incorrectin

40、sert不正确的说明书 Conflictinginformationonthelabelorinsert标签或说明书上的冲突信息 Anincorrectexpirationdatethatallowsaproducttobedistributedbeyonditsintendedexpirationdate.错误的失效日期导致产品在其预期失效日期之后分发。 Foreignproduct国外产品 Informationconcerninganybacterialcontamination.Examplesinclude,butarenotlimitedto: 有关任何细菌污染的信息。示例包括但不

41、限于： Reportedgrosscontamination报告的总污染 ViSiblemoIdgroWth可见的霉菌生长 Anysignificantchemical,physical,orotherchangeordeteriorationinthedistributeddrugproduct.Examplesinclude,butarenotlimitedto: 经销药品的任何显着的化学、物理或其他变化或变质。示例包括但不限于： Significantspotsontablets片子上的显著斑点 Significantdiscolorationordecomposition明显变色或分解

42、 Crumblingoftablets药片破碎 Precipitateinasolution溶液中的沉淀 Hazardoussubstances,suchasglass,metal,strongforeignodor.有害物质,如玻璃、金属、强烈的异味。 Anyfailureofoneormoredistributedbatchesofthedrugproducttomeetthespecificationsestablishedforitintheapplication.Examplesinclude,butarenotlimitedto: 任何一个或多个分销批次的药品未能满足申请中为其制定

43、的规范。示例包括但不限于： Anout-of-specificationresultgeneratedduringstabilityand/oraretainsample(reservesample)analysiswithintheproductexpirationperiod. 产品有效期内转定硬和/或留样(reserVeSamPIe)分析过程中产生的不合格结果。 Wherebyretentionsampleexaminationresultsforanunexpireddistributedlotindicateanissuewithcontainer-closureintegrity,

44、label/labeling,contamination,deterioration,orotherwisenotmeetingspecifications. 因此，未过期分发批次的留样检查结果表明存在容器密闭完整性、标签/标签、污染、变质或其他不符合规格的问题。 Customercomplaintswherepreliminaryinformationandinvestigationindicatethelikelihoodofanissuewiththebatchunrelatedtomishandlingbythecustomer.(RefertoSOPforMarketComDIont

45、S.) 客户投诉，其中初步信息和调查表明批次问题的可能性与客户处理不当无关。(请参阅市场投诉SOP。) Deviations/Investigationsthatidentifyarootcauseandscopeofpotentialimpactimplicatingadistributedbatch. 确定涉及分布式批次的潜在影响的根本原因和范围的偏差/调查。oProcessofReportingtheInvestigation-FieldAlertReport:O报告调查的过程现场警示报告：oTheQualityHeadshallcommunicateanyconcernsthatare

46、identifiedforimmediateconsiderationoffilingaFieldAlertReport(FAR)basedontheexamplesprovidedabovetotheHeadofQuality-Americasand/orRegulatoryHead-USwithinthe1mworkingday(Day-I)fortheirevaluation/determinationofFieldAlertReport(FAR)applicability.(ReferAttachment-II)O质量负责人应当将被标识备案现场警示报告立即考虑任何问题（FAR）基于上面

47、提供的质量头部的例子美洲和/或监管头-1内美U工作日（Day-I）以评估/确定现场警报报告（FAR）的适用性。（参考附件二）oTheQualityHeadshallinitiateandconducttheirinvestigationfollowingtheproceduresdescribedintheSoPforInVeStigatiOns.o质量负责人应按照查稣中描述的程序启动和进行调查。oAdescriptionoftheincidentandanypreliminaryinvestigation,supportingdocumentation,rootcause,correctiv

48、eandpreventativeactions,etc.o事件描述和任何初步调查、支持文件、根本原因、纠正和预防措施等。oInaddition,theQualityHeadwillalsosubmittheinvestigationreportandCAPAstoCorporateCompliance.O此外，质量主管还将向公司合规部提交调查报告和CAPA。oCorporateComplianceshallreviewandevaluatethemulti-siteimpactofCAPAsandtakenecessaryactionsifapplicable.o公司合规部门应审杳和评估CAPA的多站点影响，并在适用时采取必要措施。oActionspriortoSubmissionofFieldAlertReport:O提交现场警示报告之前的行动：oAdditionally,CorporateComplianceshallprovidethefeedbacktoth