食品良好操作规范和危害分析以及基于风险的预防控制措施（英文版）.docx

Part117食品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

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117法规原文

PART117—CURRENTGOODMANUFACTURINGPRACTICE,

HAZARDANALYSIS,ANDRISK-BASEDPREVENTIVECONTROLSFORHUMANFOOD

SubpartA—GeneralProvisions

Sec.

117.1Applicabilityandstatus.

117.3Definitions.

117.4Qualificationsofindividualswhomanufacture,process,pack,orholdfood.

117.5Exemptions.

117.7ApplicabilityofsubpartsC,D,andGofthisparttoafacilitysolelyengagedinthestorageofunexposedpackagedfood.

117.8ApplicabilityofsubpartBofthisparttotheoff-farmpackingandholdingofrawagriculturalcommodities

117.9Recordsrequiredforthissubpart.

SubpartB—CurrentGoodManufacturingPractice

117.10Personnel.

117.20Plantandgrounds.

117.35Sanitaryoperations.

117.37Sanitaryfacilitiesandcontrols.

117.40Equipmentandutensils.

117.80Processesandcontrols.

117.93Warehousinganddistribution.

117.110Defectactionlevels.

SubpartC—HazardAnalysisandRisk-BasedPreventiveControls

117.126Foodsafetyplan.

117.130Hazardanalysis.

117.135Preventivecontrols.

117.136Circumstancesinwhichtheowner,operator,oragentinchargeofa

manufacturing/processingfacilityisnotrequiredtoimplementapreventivecontrol.117.137Provisionofassurancesrequiredunder§117.136(a)(2),(3),and(4).

117.139Recallplan.

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117.140Preventivecontrolmanagementcomponents.

117.145Monitoring.

117.150Correctiveactionsandcorrections.

117.155Verification.

117.160Validation.

117.165Verificationofimplementationandeffectiveness.

117.170Reanalysis.

117.180Requirementsapplicabletoapreventivecontrolsqualifiedindividualandaqualifiedauditor.

117.190Implementationrecordsrequiredforthissubpart.

SubpartD—ModifiedRequirements

117.201Modifiedrequirementsthatapplytoaqualifiedfacility.

117.206Modifiedrequirementsthatapplytoafacilitysolelyengagedinthestorageofunexposedpackagedfood.

SubpartE—WithdrawalofaQualifiedFacilityExemption

117.251Circ