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
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