现场警报报告提交SOP.docx

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/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/GuidelinedescribestheprocesstosubmitthecurrentFormFDA3331andanyothersubsequentcommunicationstotheFDAfordrugproductsdistributedtotheU.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)。oFieldAlertReport(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/Guidelineismandatory,andthisSOP/Guidelineisapplicablegloballytoallcompany'sproductsmarketedtotheUSmarket.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。oTherequirementsforreportingBiologicalDeviationReports(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)forevaluation/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。oInitiatingaformalinvestigation,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。oImplementingimmediateactionssuchasblockingaffectedbatches,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)。oInvestigating,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：oReceivingcommunicationfromthemanufacturingsites,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21CFR§314.8I(b)(l)(i)和(ii)评估和确定现场警报报告(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.o指导生产现场和质量团队满足卫生当局的期望。oHeadofQualityandCompliance/HeadOfManufacturing/Re