保健品GMP良好规范操作.docx
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保健品GMP良好规范操作
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
Contents
SubpartA—GeneralProvisions
§ 111.1 Whoissubjecttothispart?
§ 111.3 Whatdefinitionsapplytothispart?
§ 111.5 Dootherstatutoryprovisionsandregulationsapply?
SubpartB—Personnel
§ 111.8 WhataretherequirementsunderthissubpartBforwrittenprocedures?
§ 111.10 Whatrequirementsapplyforpreventingmicrobialcontaminationfromsickorinfectedpersonnelandforhygienicpractices?
§ 111.12 Whatpersonnelqualificationrequirementsapply?
§ 111.13 Whatsupervisorrequirementsapply?
§ 111.14 UnderthissubpartB,whatrecordsmustyoumakeandkeep?
SubpartC—PhysicalPlantandGrounds
§ 111.15 Whatsanitationrequirementsapplytoyourphysicalplantandgrounds?
§ 111.16 WhataretherequirementsunderthissubpartCforwrittenprocedures?
§ 111.20 Whatdesignandconstructionrequirementsapplytoyourphysicalplant?
§ 111.23 UnderthissubpartC,whatrecordsmustyoumakeandkeep?
SubpartD—EquipmentandUtensils
§ 111.25 WhataretherequirementsunderthissubpartDforwrittenprocedures?
§ 111.27 Whatrequirementsapplytotheequipmentandutensilsthatyouuse?
§ 111.30 Whatrequirementsapplytoautomated,mechanical,orelectronicequipment?
§ 111.35 UnderthissubpartD,whatrecordsmustyoumakeandkeep?
SubpartE—RequirementtoEstablishaProductionandProcessControlSystem
§ 111.55 Whataretherequirementstoimplementaproductionandprocesscontrolsystem?
§ 111.60 Whatarethedesignrequirementsfortheproductionandprocesscontrolsystem?
§ 111.65 Whataretherequirementsforqualitycontroloperations?
§ 111.70 Whatspecificationsmustyouestablish?
§ 111.73 Whatisyourresponsibilityfordeterminingwhetherestablishedspecificationsaremet?
§ 111.75 Whatmustyoudotodeterminewhetherspecificationsaremet?
§ 111.77 Whatmustyoudoifestablishedspecificationsarenotmet?
§ 111.80 Whatrepresentativesamplesmustyoucollect?
§ 111.83 Whataretherequirementsforreservesamples?
§ 111.87 Whoconductsamaterialreviewandmakesadispositiondecision?
§ 111.90 Whatrequirementsapplytotreatments,in-processadjustments,andreprocessingwhenthereisadeviationorunanticipatedoccurrenceorwhenaspecificationestablishedinaccordancewith§ 111.70isnotmet?
§ 111.95 UnderthissubpartE,whatrecordsmustyoumakeandkeep?
SubpartF—ProductionandProcessControlSystem:
RequirementsforQualityControl
§ 111.103 WhataretherequirementsunderthissubpartFforwrittenprocedures?
§ 111.105 Whatmustqualitycontrolpersonneldo?
§ 111.110 Whatqualitycontroloperationsarerequiredforlaboratoryoperationsassociatedwiththeproductionandprocesscontrolsystem?
§ 111.113 Whatqualitycontroloperationsarerequiredforamaterialreviewanddispositiondecision?
§ 111.117 Whatqualitycontroloperationsarerequiredforequipment,instruments,andcontrols?
§ 111.120 Whatqualitycontroloperationsarerequiredforcomponents,packaging,andlabelsbeforeuseinthemanufactureofadietarysupplement?
§ 111.123 Whatqualitycontroloperationsarerequiredforthemastermanufacturingrecord,thebatchproductionrecord,andmanufacturingoperations?
§ 111.127 Whatqualitycontroloperationsarerequiredforpackagingandlabelingoperations?
§ 111.130 Whatqualitycontroloperationsarerequiredforreturneddietarysupplements?
§ 111.135 Whatqualitycontroloperationsarerequiredforproductcomplaints?
§ 111.140 UnderthissubpartF,whatrecordsmustyoumakeandkeep?
SubpartG—ProductionandProcessControlSystem:
RequirementsforComponents,Packaging,andLabelsandforProductThatYouReceiveforPackagingorLabelingasaDietarySupplement
§ 111.153 WhataretherequirementsunderthissubpartGforwrittenprocedures?
§ 111.155 Whatrequirementsapplytocomponentsofdietarysupplements?
§ 111.160 Whatrequirementsapplytopackagingandlabelsreceived?
§ 111.165 Whatrequirementsapplytoaproductreceivedforpackagingorlabelingasadietarysupplement（andfordistributionratherthanforreturntothesupplier）?
§ 111.170 Whatrequirementsapplytorejectedcomponents,packaging,andlabels,andtorejectedproductsthatarereceivedforpackagingorlabelingasadietarysupplement?
§ 111.180 UnderthissubpartG,whatrecordsmustyoumakeandkeep?
SubpartH—ProductionandProcessControlSystem:
RequirementsfortheMasterManufacturingRecord
§ 111.205 Whatistherequirementtoestablishamastermanufacturingrecord?
§ 111.210 Whatmustthemastermanufacturingrecordinclude?
SubpartI—ProductionandProcessControlSystem:
RequirementsfortheBatchProductionRecord
§ 111.255 Whatistherequirementtoestablishabatchproductionrecord?
§ 111.260 Whatmustthebatchrecordinclude?
SubpartJ—ProductionandProcessControlSystem:
RequirementsforLaboratoryOperations
§ 111.303 WhataretherequirementsunderthissubpartJforwrittenprocedures?
§ 111.310 Whataretherequirementsforthelaboratoryfacilitiesthatyouuse?
§ 111.315 Whataretherequirementsforlaboratorycontrolprocesses?
§ 111.320 Whatrequirementsapplytolaboratorymethodsfortestingandexamination?
§ 111.325 UnderthissubpartJ,whatrecordsmustyoumakeandkeep?
SubpartK—ProductionandProcessControlSystem:
RequirementsforManufacturingOperations
§ 111.353 WhataretherequirementsunderthissubpartKforwrittenprocedures?
§ 111.355 Whatarethedesignrequirementsformanufacturingoperations?
§ 111.360 Whataretherequirementsforsanitation?
§ 111.365 Whatprecautionsmustyoutaketopreventcontamination?
§ 111.370 Whatrequirementsapplytorejecteddietarysupplements?
§ 111.375 UnderthissubpartK,whatrecordsmustyoumakeandkeep?
SubpartL—ProductionandProcessControlSystem:
RequirementsforPackagingandLabelingOperations
§ 111.403 WhataretherequirementsunderthissubpartLforwrittenprocedures?
§ 111.410 Whatrequirementsapplytopackagingandlabels?
§ 111.415 Whatrequirementsapplytofilling,assembling,packaging,labeling,andrelatedoperations?
§ 111.420 Whatrequirementsapplytorepackagingandrelabeling?
§ 111.425 Whatrequirementsapplytoapackagedandlabeleddietarysupplementthatisrejectedfordistribution?
§ 111.430 UnderthissubpartL,whatrecordsmustyoumakeandkeep?
SubpartM—HoldingandDistributing
§ 111.453 WhataretherequirementsunderthissubpartforMwrittenprocedures?
§ 111.455 Whatrequirementsapplytoholdingcomponents,dietarysupplements,packaging,andlabels?
§ 111.460 Whatrequirementsapplytoholdingin-processmaterial?
§ 111.465 Whatrequirementsapplytoholdingreservesamplesofdietarysupplements?
§ 111.470 Whatrequirementsapplytodistributingdietarysupplements?
§ 111.475 UnderthissubpartM,whatrecordsmustyoumakeandkeep?
SubpartN—ReturnedDietarySupplements
§ 111.503 WhataretherequirementsunderthissubpartNforwrittenprocedures?
§ 111.510 Whatrequirementsapplywhenareturneddietarysupplementisreceived?
§ 111.515 Whenmustareturneddietarysupplementbedestroyed,orotherwisesuitablydisposedof?
§ 111.520 Whenmayareturneddietarysupplementbesalvaged?
§ 111.525 Whatrequirementsapplytoareturneddietarysupplementthatqualitycontrolpersonnelapproveforreprocessing?
§ 111.530 Whenmustaninvestigationbeconductedofyourmanufacturingprocessesandotherbatches?
§ 111.535 UnderthissubpartN,whatrecordsmustyoumakeandkeep?
SubpartO—ProductComplaints
§ 111.553 WhataretherequirementsunderthissubpartOforwrittenprocedures?
§ 111.560 Whatrequirementsapplytothereviewandinvestigationofaproductcomplaint?
§ 111.570 UnderthissubpartO,whatrecordsmustyoumakeandkeep?
SubpartP—RecordsandRecordkeeping
§ 111.605 Whatrequirementsapplytotherecordsthatyoumakeandkeep?
§ 111.610 WhatrecordsmustbemadeavailabletoFDA?
目录：
A节-总则
111.1适用性
111.3定义
111.5其它规定要求
B节-人员
111.8B节下规定的书面程序
111.10防止微生物污染的要求
111.12人员资质要求
111.13监督员要求
111.14B节中规定的记录
C节-实体工厂与地面
111.15卫生要求
111.16本C节中的书面程序要求
111.20工厂的设计与建设要求
111.23C节中规定的记录
D节-设备与器具
111.25本D节中的书面程序要求
111.27设备及器具要求
111.30自动化、机械或电子设备要求
111.35D节中规定的记录
E节-建立生产及过程控制系统的要求
111.55生产及过程控制系统要求
111.60生产及过程控制系统设计要求
111.65质量管理操作要求
111.70必要规范
111.73判断是否满足规范的要求
111.75如何判断是否满足规范
111.77如未达到规范要求所需采取的措施
111.80代表性样品
111.83保留样品
111.87材料审核并做出处理决定
111.90出现偏差或意外情况时的要求
111.95E节中规定的记录
F节-生产与过程控制系统：
质量管理要求
111.103F节中规定的书面程序
111.105质量控制人员职责
111.110与生产过程控制体系相关的实验室质量控制操作
111.113材料审核与处理决定需要质量管理操作
111.117设备、仪器与控制装置的质量管理操作
111.120用于膳食补充剂生产之前的组分、包装与标签的质量管理操作
111.123基本生产记录、批量生产记录及生产运营的质量管理操作
111.127包装与标签粘贴的质量管理操作
111.130退回的膳食补充剂需要质量管理操作
111.135产品投诉的质量管理操作
111.140F节中规定的记录
G节-生产与过程控制体系：
对于组分、包装与标签、以及接收用作膳食补充剂包装或粘贴标签的产品的要求
111.153G节中规定的书面程序
111.155膳食补充剂组分要求
111.160包装与标签的接收要求
111.165作为膳食补充剂包装或粘贴标签产品（并用于配送）的接收要求
111.170对于拒收组分、包装、标签或拒收产品的要求
111.180G节中规定的记录
H节-生产与过程控制体系：
基本生产记录要求
111.205建立基本生产记录的要求
111.210基本生产记录的组成部分
I节-生产与过程控制体系：
批量生产记录要求
111.255编写批量生产记录的要求
111.260批量记录组成部分
J节-生产与过程控制体系：
实验室操作要求
111.303J节中规定的书面程序
111.310实验室设施要求
111.315实验室控制程序要求
111.320实验室测试与检验方法要求
111.325J节中规定的记录
K节-生产与过程控制体系：
生产操作要求
111.353K节中对于书面程序具体要求
111.355生产操作设计要求
111.360卫生要求
111.365防止污染的预防措施
111.370关于退回的膳食补充剂的要求
111.375K节中规定的记录
L节-生产与过程控制体系：
包装及标签操作要求
111.403L节中规定的书面程序
111.410包装及标签所适用的要求
111.415装填、组装、包装、标签及相关操作的要求
111.420重新包装及重新粘贴
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