FDA水产品HACCP法规中英文.ppt

FDA水产品HACCP法规 21CFR123 1240 FDA水产品HACCP法规 SubpartADefinitions定义GoodManufacturingPractices GMP HazardAnalysis HazardAnalysisCriticalControlPointplan HACCP计划 CorrectiveActions纠正措施Verification验证Records记录Training培训Sanitation卫生 SSOP RequirementsofImportedProducts对进口产品的要求 FDA水产品HACCP法规 SubpartB SmokedFish烟熏鱼 FDA水产品HACCP法规 SubpartC RawMolluscanShellfish生的软体贝类 FDA水产品HACCP法规 HACCP只适用于 食品安全的危害 FDA水产品HACCP法规 SubpartA适用于所有加工者 FDA水产品HACCP法规 不受法规制约的设施 FishingVessels捕捞船TransportationVehicles运输工具RetailEstablishments IncludingRestaurants包括餐馆在内的零售设施 FDA水产品HACCP法规 Definitions Processing加工 Handling storing preparing heading eviscerating shucking freezing changingform manufacturing preserving packing labeling docksideunloading orholding FDA水产品HACCP法规 Definitions Fish水产 allformsofaquaticanimallifeintendedforhumanconsumption includingamphibians mollusks androe FDA水产品HACCP法规 Definitions FisheryProducts水产制品 anyhumanfoodproductinwhichfishisthecharacterizingingredient FDA水产品HACCP法规 GoodManufacturingPractices GMP s TiesGMP sHACCPregulations FDA水产品HACCP法规 IncludesallsevenprinciplesofHACCP七个原则或原理 ConductingaHazardAnalysis危害分析IdentifyingCriticalControlPoints CCP 确定关键控制点EstablishingCriticalLimits建立关键限值MonitoringEachCCP监测每个CCP点EstablishingCorrectiveActionstobeTakenWhenaCriticalLimitDeviationOccurs纠正措施EstablishingaRecord KeepingSystem记录保持系统EstablishingVerificationProcedures验证程序 FDA水产品HACCP法规 Conductingahazardanalysis Aretherefoodsafetyhazardsassociatedwithmyproductthatarereasonablylikelytooccur AretherepreventativemeasuresthatIcanapplytocontrolthesehazards Hazardsaredefinedasphysical microbiologicaland orchemical物理 化学与生物危害 FDA水产品HACCP法规 Hazardmustbeonethatisreasonablylikelytooccur极可能发生的危害 FDA水产品HACCP法规 Noonewaytodoahazardanalysis进行危害分析的途径很多BecertaintousetheGuide一定要使用 指南 Nohazards NoHACCPplanisnecessary没有 显著 危害 就不需要HACCP计划 FDA水产品HACCP法规 TheHACCPPlanEachLocationEachProductHACCP计划是针对于每一个加工地点 每一种产品 FDA水产品HACCP法规 HACCP计划必须包括 TheFoodSafetyHazard食品安全危害TheCriticalControlPointsofEachHazard每一个危害的关键控制点TheCriticalLimits关键限值TheMonitoringProcedures监测程序TheRequiredRecords要求的记录ACorrectiveAction纠正措施TheVerificationProcedures验证程序 FDA水产品HACCP法规 HACCPPlan Hazardstobeconsidered要考虑到的危害 NaturalToxins天然毒素Microbiological微生物ChemicalPesticides化学杀虫剂 农药 DrugResidues药物 兽药 残留UnapprovedUsesofFoodandColorAdditives未经批准使用的食品添加剂和色素PhysicalHazards物理的危害DecompositionRelatedtoSafety与安全有关的腐败 FDA水产品HACCP法规 HACCPPlan CriticalControlPointsandCriticalLimits CriticalControlPoints关键控制点 ApointinprocessingwherecontrolsneedtobeinplaceCriticalLimits关键限值 Alimitexpressedasavalue i e timeortemperature listedatacriticalcontrolpoint FDA水产品HACCP法规 MonitoringProcedures监测程序 WhatWillBeMonitored监测什么 HowWillMonitoringBeDone怎样监测 FrequencyofMonitoring监测频率 时间 Who 谁负责监测 Where 在哪监测 FDA水产品HACCP法规 CorrectiveAction Predetermined预先确定好的纠正措施 CorrectiveActionPlans纠正措施计划 FDA水产品HACCP法规 Verification验证 Reassessment重新评估 VerifyPlansNoLessThanOnceAYear验证HACCP计划每年至少一次 FDA水产品HACCP法规 Verification ListChanges以下改变必须验证 RawMaterialsorSourcesofRawMaterials原料或原料来源ProductFormulation产品配方ProcessingMethodsorSystems加工方法或系统FinishedProductDistribution成品的配发IntendedUseoftheFinishedProductbyConsumers消费者对成品预期用途 FDA水产品HACCP法规 Verification VerifyingPerformance验证的措施 ConsumerComplaints消费者投诉CalibratingInstruments i e thermometers 校准仪器Testing检测ReviewingRecords审核记录 FDA水产品HACCP法规 Verification ReassessHazardAnalysis重新评估危害分析 ReassessHazardAnalysis WheneverThereIsaChange一旦有改变 就必须重新进行危害分析 FDA水产品HACCP法规 Records Types文件记录的类型 HACCPPlanHACCP计划MonitoringRecords监测记录CorrectiveActionRecords纠偏记录VerificationMeasures验证记录SanitationRecords卫生方面的记录ImporterVerificationRecords进口商验证记录 FDA水产品HACCP法规 Records RequiredInformation记录的信息 NameandLocationofProcessororImporter加工者或进口商的名称和地点DateandTimeofActivityBeingRecorded被记录活动的日期和时间SignatureorInitialsofPersonMakingRecord记录人员的签名ProductIdentityandCode whenappropriate 产品名称和代码 FDA水产品HACCP法规 Records Retention记录保留的时间 RefrigeratedProducts 1Year冷藏产品一年FrozenProducts 2Years冷冻产品二年 FDA水产品HACCP法规 Records Access FDAHasAccesstoHACCPRecordsandPlansandmaycopythem fordomesticprocessors FDAHasAccesstoImporterRecordsFDA有权检查有关记录 并进行复印 FDA水产品HACCP法规 PlanContents 复习 HHACCP计划的内容包括 Hazards危害CriticalControlPoints关键控制点CriticalLimits关键限值CorrectiveActions纠正措施Records记录Verification验证 FDA水产品HACCP法规 Training Options培训方面的要求 TraininginHACCP参加相当的培训On TheJobExperience有一定工作经验 TheSeafoodHACCPAlliance 美国水产品HACCP联盟 FDA水产品HACCP法规 Training Choices OneTrainedEmployee工作人员参加培训TrainedConsultant请培训过的专家顾问 FDA水产品HACCP法规 Training IndividualShall下列工作必须要有一定资格的人员来进行 DeveloporAmendtheHACCPPlan制订或修改HACCP计划Reassessand orModifytheHACCPPlan重新评估 修改HACCP计划ReassessandModifytheHazardAnalysis重新评估和修改危害分析ReviewAllRecords审核所有的记录 FDA水产品HACCP法规 Sanitation PrerequisitHACCP的前提条件 PrerequisitetoHACCPMonitoring监测Records记录Corrections纠偏 FDA水产品HACCP法规 Sanitation 8Areas SSOP至少包括8个方面SafetyofWaterThatComesinContactWithFood FoodContactSurfaces orUsedtoMakeIceConditionofFoodContactSurfacesPreventionofCrossContaminationExclusionofPestsMaintenanceofHandWashing HandSanitizingandToiletFacilitiesProtectionFromContaminantsProperLabeling StorageandUseofToxicCompoundsControlofEmployeeHealthConditions FDA水产品HACCP法规 Sanitation MonitoringFrequency MonitoringFrequencies监测频率CorrectiveMeasures纠正措施Records记录 RecordsarerequiredevenifnoHACCPplanisrequired即使没有HACCP计划 仍然要求SSOP记录 FDA水产品HACCP法规 Sanitation HandledSeparately SanitationcontrolscanbeincludedintheHACCPplan 卫生控制可包含再HACCP计划中 SanitationcontrolscanbehandledoutsideoftheHACCPplan 卫生控制可不包含在HACCP计划里 IMPORTERREQUIREMENTS对进口商的要求 CoverageGeneralProvisions一般条款 AllProcessors对所有加工者SpecialRequirementsforImporters对进口商SpecialProvisions特殊条款 SmokedFishRawMolluscanShellfish Definitions定义Importer进口商 meanseithertheU S ownerorconsigneeatthetimeofentryintotheUnitedStates ortheU W agentorrepresentativeoftheforeignownerorconsigneeatthetimeofentryintheUnitedStates whoisresponsibleforensuringthatgoodsbeingofferedforentryintotheUnitedStatesareincompliancewithalllawsaffectingtheimportation Imports21CFRPart123 12ImporterVerification进口商验证ImportFromCountriesWithAnMOU从与FDA签署相应MOU的国家进口Or或ImplementVerificationProcedures实施进口商验证程序 可由有资格的第三方实施 WrittenVerificationProcedures书面的验证程序ProductSpecificationstoensurethattheproductisnotinjurioustohealthandnotprocessedunderinsanitaryconditions产品说明书AffirmativeStep确认步骤 HACCPREGULATIONOVERVIEWIMPORTERREQUIREMENTS AffirmativeStepRequirement Chooseatleastone 任选其一On sitevisitsbytheimporter进口商现场检查Obtainingtheprocessor sHACCPandsanitationrecords得到加工者的HACCP计划和卫生方面的记录Obtainingtheprocessor sHACCPplanandguarantee得到加工者的HACCP计划和保证书End producttestingandguarantee最终产品检测和保证书Obtainingacontinuingorlot by lotcertification得到连续的或逐批的证书 官方或第三方 Otherverificationmethods其他验证方法 AquacultureProcessing养殖过程中的药物使用Hazardsassociatedwithuseofmedicationsinfeedorbydirectadministration OfficeofSeafood AquacultureProcessingDrugsusedfor 药物用于Treatingandpreventingdisease治疗和预防疾病Controllingparasites控制寄生虫Controllingreproduction控制繁殖Controllinggrowth控制生长Tranquilizing镇静 OfficeofSeafood AquacultureProcessingConditionsfordrugapproval Speciesforwhichthedrugisapproved用药品种Approveddosage剂量Approvedrouteoftransmission用药途径Approvedfrequencyofuse用药频率Approvedindicationsforuse症状 OfficeofSeafood AquacultureProcessingDrugsapprovedbyFDA FDA批准的药物ChorionicGonadotropinFormalinsolutionTricainemethanesulfonateOxytetracyclineSulfamerazineSulfadimethoxine ormetoprim OfficeofSeafood AquacultureProcessingLabelsofapproveddrugslistthemandatorywithdrawaltimes whereapplicable 停药期 OfficeofSeafood AquacultureProcessingTissueresiduetoleranceshavebeenestablishedforsomedrugs 组织残留限量 OfficeofSeafood MolluscanShellfish ShellfishAuthorityGovernmentauthorityresponsibleforenforcementofallregulatoryrequirementsassociatedwithshellfish MolluscanShellfish Shellfishdefinedas OystersClamsMusselsScallops MolluscanShellfish RegulatoryrequirementsoftheShellfishAuthorityinclude GrowingareaclassificationHarvestingcontrolProcessingplantandprocedurecontrolProductlabelingStorage handlingandpackingShipmentcontrol MolluscanShellfish HazardsAssociatedWithShellfish PathogenmicroorganismsNaturalToxinsfromtheharvestwaterChemicalcontaminantsfromtheharvestwater MolluscanShellfish ImportofRawMolluscanShellfishRawmolluscanshellfishcanonlybeimportedintotheUnitedStatesfromcountriesthathaveacurrentMemorandumofUnderstanding MOU withtheUnitedStatesFoodandDrugAdministration MolluscanShellfish ImportofMolluscanS中国最大的资料库下载CurrentMOUcountriesinclude CanadaNewZealandChileSouthKorea MolluscanShellfish ControlofPathogenicMicroorganismsinShellfishfromMOUCountriesForcountriesthatcurrentlyhaveaMOUwithFDA thecontrolstrategyforpathogenicmicroorganismsisimplementationofNSSPrequirementstocontrolthegrowing harvesting processing labeling andshippingofmolluscanshellfish MolluscanShellfish ControlofPathogenicMicroorganismsinShellfishfromNon MOUCountriesForcountriesthatDONOTcurrentlyhaveaMemorandumofUnderstandingwithFDAforimportationofrawmolluscanshellfish thecontrolstrategyforpathogenicmicroorganismswillbeadequatecooking MolluscanShellfish ControlofPathogenicMicroorganismsinShellfishfromNon MOUCountriesCookingorpasteurizationprocessmustreducethetargetorganismtoanon detectablelevel MolluscanShellfish ControlofPathogenicMicroorganismsCountriesthatdonotcurrentlyhaveaMemorandumofUnderstandingwiththeUnitedStatesforrawmolluscanshellfishareNOTpermittedtoimportrawshellfishintotheUnitedStates MolluscanShellfish ControlofNaturalToxinsCookedmolluscanshellfishispermittedtobeimportedintotheUnitedStatesonlyiftheprocessorhascontrolledthehazardsassociatedwithnaturaltoxinsfromtheharvestwater MolluscanShellfish ControlofNaturalToxinsCookingwillnoteliminateorsignificantlyreducethelevelofnaturaltoxinsinshellfishmeats MolluscanShellfish ControlofNaturalToxins2methodsofControlMonitoringofshellfishmeatsfrom key locationsinthegrowingareasORMonitoringofshellfishmeatsonalot by lotbasisattheprocessingfacility MolluscanShellfish ControlofNaturalToxinsIfnaturaltoxinsarecontrolledbymonitoringshellfishatthegrowingarea theControlAuthoritymusthaveauthoritytoclosetheareafromharvestingwhenunsafelevelsarepresentinshellfishmeats MolluscanShellfish ControlofNaturalToxinsTherearefourrecognizedshellfishpoisoningsyndromesresultingfromnaturaltoxinsproducedbymarinealgae MolluscanShellfish ControlofNaturalToxinsParalyticShellfishPoisoning PSP NeurotoxicShellfishPoisoning NSP DiarrheticShellfishPoisoning DSP AmnesicShellfishPoisoning ASP MolluscanShellfish ControlofNaturalToxinsActionLevelsinMeatsParalyticShellfishPoisoning 0 8PPM 80ug 100g saxitoxinequivalent MolluscanShellfish ControlofNaturalToxinsActionLevelsinMeatsNeurotoxicShellfishPoisoning 0 8PPM 20mouseunits 100g brevetoxin 2equivalent MolluscanShellfish ControlofNaturalToxinsActionLevelsinMeatsDiarrheticShellfishPoisoning 0 2PPMokada