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保健品GMP良好规范操作.doc

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保健品GMP良好规范操作.doc

上传人:雾里看花 2019/2/21 文件大小:375 KB

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保健品GMP良好规范操作.doc

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文档介绍:PART111—CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PACKAGING,LABELING,ORHOLDINGOPERATIONSFORDIETARYSUPPLEMENTS食品与药物管理局膳食补充剂生产、包装、标签粘贴、保存现行生产质量管理规范21CFR111部分111部分-膳食补充剂生产、包装、标签粘贴、保存现行生产质量管理规范ContentsSubpartA—GeneralProvisions§    Whoissubjecttothispart?§    Whatdefinitionsapplytothispart?§    Dootherstatutoryprovisionsandregulationsapply?SubpartB—Personnel§    WhataretherequirementsunderthissubpartBforwrittenprocedures?§    Whatrequirementsapplyforpreventingmicrobialcontaminationfromsickorinfectedpersonnelandforhygienicpractices?§    Whatpersonnelqualificationrequirementsapply?§    Whatsupervisorrequirementsapply?§    UnderthissubpartB,whatrecordsmustyoumakeandkeep?SubpartC—PhysicalPlantandGrounds§    Whatsanitationrequirementsapplytoyourphysicalplantandgrounds?§    WhataretherequirementsunderthissubpartCforwrittenprocedures?§    Whatdesignandconstructionrequirementsapplytoyourphysicalplant?§    UnderthissubpartC,whatrecordsmustyoumakeandkeep?SubpartD—EquipmentandUtensils§    WhataretherequirementsunderthissubpartDforwrittenprocedures?§    Whatrequirementsapplytotheequipmentandutensilsthatyouuse?§    Whatrequirementsapplytoautomated,mechanical,orelectronicequipment?§    UnderthissubpartD,whatrecordsmustyoumakeandkeep?SubpartE—RequirementtoEstablishaProductionandProcessControlSystem§    Whataretherequirementstoimplementaproductionandprocesscontrolsystem?§    Whatarethedesignrequirementsfortheproductionandprocesscontrolsystem?§    Whataretherequirementsforqualitycontroloperations?§    Whatspecificationsmustyouestablish?§    Whatisyourresponsibilityfordeterminingwhetherestablishedspecificationsaremet?§    Whatmustyoudotodeterminewhetherspecificationsaremet?§    Whatmustyoudoifestablishedspecificationsarenotmet?§    Whatrepresentativesamplesmustyoucollect?§    Whataretherequirementsforreservesamples?§    Whoconductsa