美国联邦法规第21章117部分

21CFRPART117美国联邦法规第21章117部分PART117—CURRENTGOODMANUFACTURINGPRACTICE,HAZARDANALYSIS,ANDRISKBASEDPREVENTIVECONTROLSFORHUMANFOOD117---适用于人类食品的现行良好操作规范和危害分析及基于风险的预防性控制措施SubpartA—GeneralProvisionsA部分---总则117.1Applicabilityandstatus.117.1适用范围和法律地位117.3Definitions.117.3定义117.4Qualificationsofindividualswhomanufacture,process,pack,orholdfood.117.4从事生产、加工、包装或储存人员的资质认定117.5Exemptions.117.5豁免117.7ApplicabilityofsubpartsC,D,andGofthisparttoafacilitysolelyengagedinthestorageofunexposedpackagedfood.117.7本法规C部分、D部分和G部分对仅从事密封包装食品储存企业的适用性117.8ApplicabilityofsubpartBofthisparttotheofffarmpackingandholdingofrawagriculturalcommodities117.8本法规B部分对“在农场外进行初级农产品包装”和“初级农产品储存”的适用性117.9Recordsrequiredforthissubpart.117.9本部分要求的记录SubpartB—CurrentGoodManufacturingPracticeB部分—现行良好操作规范117.10Personnel.117.10人员117.20Plantandgrounds.117.20工厂和场地117.35Sanitaryoperations.117.35卫生操作117.37Sanitaryfacilitiesandcontrols.117.37卫生设施和控制117.40Equipmentandutensils.117.40设备和器具117.80Processesandcontrols.117.80过程和控制117.93Warehousinganddistribution.117.93仓库和分发117.110Defectactionlevels.117.110缺陷行动水平SubpartC—HazardAnalysisandRiskBasedPreventiveControlsC部分—危害分析和基于风险的预防性控制117.126Foodsafetyplan.117.126食品安全计划117.130Hazardanalysis.117.130危害分析117.135Preventivecontrols.117.135预防性控制117.136Circumstancesinwhichtheowner,operator,oragentinchargeofamanufacturing/processingfacilityisnotrequiredtoimplementapreventivecontrol.117.136生产/加工企业的所有者、经营者或代理方不需实施预防性控制措施的情况117.137Provisionofassurancesrequiredunder§117.136(a)(2),(3),and(4).117.137按照§117.136(a)(2),(3),and(4).的要求提供保证117.139Recallplan.117.139召回计划117.140Preventivecontrolmanagementcomponents.117.140预防性控制措施管理要素117.145Monitoring.117.145监控117.150Correctiveactionsandcorrections.117.150纠正措施和纠正117.155Verification.117.155验证117.160Validation.117.160确认117.165Verificationofimplementationandeffectiveness.117.165实施和有效性的验证117.170Reanalysis.117.170再分析117.180Requirementsapplicabletoapreventivecontrolsqualifiedindividualandaqualifiedauditor.117.180适用于预防控制合格人员和合格审核员的要求117.190Implementationrecordsrequiredforthissubpart.117.190本部分要求的实施的记录SubpartD—ModifiedRequirementsD部分—简化要求117.201Modifiedrequirementsthatapplytoaqualifiedfacility.117.201适用于“符合条件的企业”的简化要求117.206Modifiedrequirementsthatapplytoafacilitysolelyengagedinthestorageofunexposedpackagedfood.117.206适用于仅从事密封包装食品储存的企业的简化要求SubpartE—WithdrawalofaQualifiedFacilityExemptionE部分—符合条件企业的豁免撤销117.251CircumstancesthatmayleadFDAtowithdrawaqualifiedfacilityexemption.117.251可能导致FDA撤销符合条件的企业豁免的情况117.254Issuanceofanordertowithdrawaqualifiedfacilityexemption.117.254符合条件企业豁免撤销命令的签发117.257Contentsofanordertowithdrawaqualifiedfacilityexemption.117.257符合条件企业豁免撤销命令的内容117.260Compliancewith,orappealof,anordertowithdrawaqualifiedfacilityexemption.117.260对撤销符合条件企业豁免命令的遵守或申诉117.264Procedureforsubmittinganappeal.117.264申诉提交的程序117.267Procedureforrequestinganinformalhearing.117.267非正式听证会的申请程序117.270Requirementsapplicabletoaninformalhearing.117.270适用于非正式听证会的要求117.274Presidingofficerforanappealandforaninformalhearing.117.274负责申诉和非正式听证会的的主管官员117.277Timeframeforissuingadecisiononanappeal.117.277出具申诉决议的时限117.280Revocationofanordertowithdrawaqualifiedfacilityexemption.117.280符合条件企业豁免撤销命令的取消117.284Finalagencyaction.117.284最终行政措施117.287Reinstatementofaqualifiedfacilityexemptionthatwaswithdrawn.117.287被撤销符合条件企业豁免的恢复SubpartF—RequirementsApplyingtoRecordsThatMustBeEstablishedandMaintainedF部分—针对必须建立并留存记录的要求117.301Recordssubjecttotherequirementsofthissubpart.117.301本章节所要求的记录117.305Generalrequirementsapplyingtorecords.117.305记录的一般要求117.310Additionalrequirementsapplyingtothefoodsafetyplan.117.310针对于食品安全计划的附加要求117.315Requirementsforrecordretention.117.315记录保存的要求117.320Requirementsforofficialreview.117.320官方复核的要求117.325Publicdisclosure.117.325公开117.330Useofexistingrecords.117.330现有记录的使用117.335Specialrequirementsapplicabletoawrittenassurance.117.335适用于书面保证的特殊要求SubpartG—SupplyChainProgramG部分—供应链计划117.405Requirementtoestablishandimplementasupplychainprogram.117.405建立和实施供应链计划的要求117.410Generalrequirementsapplicabletoasupplychainprogram.117.410供应链计划的通用要求117.415Responsibilitiesofthereceivingfacility.117.415接收企业的职责117.420Usingapprovedsuppliers.117.420使用获得批准的供应商117.425Determiningappropriatesupplierverificationactivities(includingdeterminingthefrequencyofconductingtheactivity).117.425确定适宜的供应商验证活动（包括确定实施的频率）117.430Conductingsupplierverificationactivitiesforrawmaterialsandotheringredients.117.430对原料供和其他辅料供应商的验证活动117.435Onsiteaudit.117.435现场审核117.475Recordsdocumentingthesupplychainprogram.117.475供应链计划的文件记录AUTHORITY授权:21U.S.C.331,342,343,350dnote,350g,350gnote,371,374;42U.S.C.243,264,271.SubpartA—GeneralProvisionsA—总则§117.1Applicabilityandstatus.§117.1适用范围和法律地位(a)Thecriteriaanddefinitionsinthispartapplyindeterminingwhetherafoodis:(a)本部分中的标准和定义对判定以下情况时使用：(1)Adulteratedwithinthemeaningof:(1)是否受到掺杂，此处“掺杂”是指：(i)Section402(a)(3)oftheFederalFood,Drug,andCosmeticActinthatthefoodhasbeenmanufacturedundersuchconditionsthatitisunfitforfood;or(i)《联邦食品，药品和化妆品法案》中的402(a)(3)部分指出食品在不适合食品的条件下加工生产，或(ii)Section402(a)(4)oftheFederalFood,Drug,andCosmeticActinthatthef