CRF 21 Part 111 膳食补充剂GMP规范中英文对照

[Title21,Volume2][RevisedasofApril1,2015][CITE:21CFR111]TITLE21--FOODANDCHAPTERI--FOODANDDRUGADMINISTRATIONDEPARTMENTOFHEALTHANDHUMANSERVICESSUBCHAPTERB--FOODFORHUMANCONSUMPTIONPART111 CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PACKAGING,LABELING,ORHOLDINGOPERATIONSFORDIETARY第111部分饮食添加剂生产、包装、标签和储藏操作的CGMP规范SubpartA--GeneralProvisions一般规定Sec.111.1Whoissubjecttothis(a)Exceptasprovidedbyparagraph(b)ofthissection,youaresubjecttothispartifyoumanufacture,package,label,orholdadietarysupplement,including:除了bAdietarysupplementyoumanufacturebutthatispackagedorlabeledbyanotherpersonandAdietarysupplementimportedorofferedforimportinanyStateorterritoryoftheUnitedStates,theDistrictofColumbia,ortheCommonwealthofPuertoRico.(b)Therequirementspertainingtoholdingdietarysupplementsdonotapplytoyouifyouareholdingthosedietarysupplementsataretailestablishmentforthesolepurposeofdirectretailsaletoindividualconsumers.AretailestablishmentdoesnotincludeawarehouseorotherstoragefacilityforaretailerSec111.3Whatdefinitionsapplytothispart?Drug,andCosmeticAct(theact)applytosuchtermswhenusedinthispart.Forthepurposeofthispart,thefollowingdefinitionsalsoapply:联邦食品、药品和化妆品法案（该法案）第201节中的定义和术语解释适用于此部分Actualyieldmeansthequantitythatisactuallyproducedatanyappropriatestepofmanufactureorpackagingofaparticulardietarysupplement.thatisproducedduringaspecifiedtimeperiodaccordingtoasinglemanufacturingrecordduringthesamecycleofmanufacture.批是指在规定限度内具有同一性质和质量,并在同一连续生产周期中生产出来的一定Batchnumber,lotnumber,orcontrolnumbermeansanydistinctivegroupofletters,numbers,orsymbols,oranycombinationofthem,fromwhichthecompletehistoryofthemanufacturing,packaging,labeling,and/orholdingofabatchorlotofdietarysupplementscanbedetermined.Componentmeansanysubstanceintendedforuseinthemanufactureofadietarysupplement,includingthosethatmaynotappearinthefinishedbatchofthedietarysupplement.Componentincludesdietaryingredients(asdescribedinsection201(ff)oftheact)andotheringredients.1。Contactsurfacemeansanysurfacethatcontactsacomponentordietarysupplement,andthosesurfacesfromwhichdrainageontothecomponentordietarysupplement,orontosurfacesthatcontactthecomponentordietarysupplement,occursduringthenormalcourseofoperations.Examplesofcontactsurfacesincludecontainers,utensils,tables,contactsurfacesofequipment,andIngredientmeansanysubstancethatisusedinthemanufactureofadietarysupplementandthatisintendedtobepresentinthefinishedbatchofthedietarysupplement.Aningredientincludes,butisnotnecessarilylimitedto,adietaryingredientasdefinedinsection201(ff)oftheact.1In-processmaterialmeansanymaterialthatisfabricated,compounded,blended,ground,extracted,sifted,sterilized,derivedbychemicalreaction,orprocessedinanyotherwayforuseinthemanufactureofadietarysupplement.Lotmeansabatch,oraspecificidentifiedportionofabatch,thatisuniformandthatisintendedtomeetspecificationsforidentity,purity,strength,andcomposition;or,inthecaseofadietarysupplementproducedbycontinuousprocess,aspecificidentifiedamountproducedinaspecifiedunitoftimeoridentity,purity,strength,andcomposition.Microorganismsmeansyeasts,molds,bacteria,viruses,andothersimilarmicroscopicorganismshavingpublichealthorsanitaryconcern.Thisdefinitionincludesspeciesthat:Maycauseacomponentordietarysupplementtodecompose;Indicatethatthecomponentordietarysupplementiscontaminatedwithfilth;orOtherwisemaycausethecomponentordietarysupplementtobePestmeansanyobjectionableinsectorotheranimalincludingbirds,rodents,flies,mites,andlarvae.Physicalplantmeansalloranypartofabuildingorfacilityusedfororinconnectionwithmanufacturing,packaging,labeling,orholdingadietaryProductcomplaintmeansanycommunicationthatcontainsanyallegation,Examplesofproductcomplaintsare:Foulodor,offtaste,illnessorinjury,disintegrationtime,colorvariation,tabletsizeorsizevariation,under-filledmislabeling,ordietarysupplementsthataresuperpotent,subpotent,orcontainthewrongingredient,orcontainadrugorothercontaminant(e.g.,bacteria,pesticide,mycotoxin,glass,lead).电子或口头形式提出意见的一切包含任何主张的通信。产品投诉实例包括：恶臭、变味、疾病或伤害、分解时间、变色、片剂大小或大小变化、容器未满、膳食补充剂容器内有异specificationsforidentity,purity,strength,andcomposition,andlimitsoncontaminants,andhasbeenmanufactured,packaged,labeled,andheldunderconditionstopreventadulterationundersection402(a)(1),(a)(2),(a)(3),and(a)(4)oftheact.)、Qualitycontrolmeansaplannedandsystematicoperationorprocedureforensuringthequalityofadietarysupplement.Qualitycontrolpersonnelmeansanyperson,persons,orgroup,withinorcontroloperations.Representativesamplemeansasamplethatconsistsofanadequatenumberofunitsthataredrawnbasedonrationalcriteria,suchasrandomsampling,and代表性样品是指根据合理标准确定（如随机抽样）uncontaminatedcomponentsordietarysupplementsthathavebeenpreviouslyremovedfrommanufacturingandthathavebeenmadesuitableforuseinthemanufactureofadietarysupplement.程中。Reservesamplemeansarepresentativesampleofproductthatisheldforadesignatedperiodoftime.anyothercleanedcontactsurfacebyaprocessthatiseffectiveindestroyingvegetativecellsofmicroorganismsofpublichealthsignificance,andinsubstantiallyreducingnumbersofothermicroorganisms,butwithoutadverselyTheoreticalyieldmeansthequantitythatwouldbeproducedatanyappropriatestepofmanufactureorpackagingofaparticulardietarysupplement,baseduponthequantityofcomponentsorpackagingtobeused,intheabsenceofanylossorerrorinactualproduction.supplementandisthequotientofthewatervaporpressureofthesubstancedividedbythevaporpressureofpurewateratthesametemperature.WemeanstheU.SFoodandDrugAdministration(FDA).Youmeansapersonwhomanufactures,packages,labels,orholdsInadditiontothispart,youmustcomplywithotherapplicablestatutoryprovisionsandregulationsundertheactrelatedtodietarysupplements.人员Sec.111.8WhataretherequirementsunderthissubpartBforwritten requirementsofthissubpart.Preventingmicrobialcontamination.Youmusttakemeasurestoexcludefromanyoperationsanypersonwhomightbeasourceofmicrobialanymaterial,includingcomponents,dietarysupplements,andcontactsurfacesusedinthemanufacture,packaging,labeling,orholdingofadietarysupplement.Suchmeasuresincludethefollowing:anypersonwho,bymedicalexamination,theperson'sacknowledgement,oropenlesion,oranyotherabnormalsourceofmicrobialcontamination,thatcouldresultinmicrobialcontaminationofcomponents,dietarysupplements,orcontactsurfaces,untilthehealthconditionnolongerexists;and(2)Instructingyouremployeestonotifytheirsupervisor(s)iftheyhaveorifthereisareasonablepossibilitythattheyhaveahealthconditiondescribedinparagraph(a)(1)ofthissectionthatcouldresultinmicrobialcontaminationofanycomponents,dietarysupplements,oranycontactsurface.如果员工有或者可能有a部分（1）中所述的可能导致产品主成分、膳食补充剂Hygienicpractices.Ifyouworkinanoperationduringwhichadulterationofthecomponent,dietarysupplement,orcontactsurfacecouldoccur,youmustusehygienicpracticestotheextentnecessarytoprotectagainstsuchcontaminationofcomponents,dietarysupplements,orcontactsurfaces.Thesehygienicpracticesincludethefollowing:Wearingoutergarmentsinamannerthatprotectsagainstthecontaminationofcomponents,dietarysupplements,oranycontactsurface;MaintainingadequatepersonalWashinghandsthoroughly(andsanitizingifnecessarytoprotectagainstcontaminationwithmicroorganisms)inanadequatehand-washingfacility:用适当的洗手设施彻底洗手（如有必要需进行消毒，以防止微生物污染BeforestartingworkandAtanytimewhenthehandsmayhavebecomesoiledorcontaminated;Removingallunsecuredjewelryandotherobjectsthatmightfallintocomponents,dietarysupplements,equipment,orpackaging,andremovinghandjewelrythatcannotbeadequatelysanitizedduringperiodsinwhichcomponentsordietarysupplementsaremanipulatedbyhand.Ifhandjewelrycannotberemoved,itmustbecoveredbymaterialthatismaintainedinanintact,clean,andsanitaryconditionandthateffectivelyprotectsagainstcontaminationofcomponents,dietarysupplements,orcontactsurfaces;（Maintainingglovesusedinhandlingcomponentsordietarysupplementsinanintact,clean,andsanitarycondition.Theglovesmustbeofanimpermeable使用的手套（如果用它们处理膳食补充剂）Wearing,whereappropriate,inaneffectivemanner,hairnets,caps,beardcovers,orothereffectivehairrestraints;（Notstoringclothingorotherpersonalbelongingsinareaswherecomponents,dietarysupplements,oranycontactsurfacesareexposedorwherecontactsurfacesarewashed;Noteatingfood,chewinggum,drinkingbeverages,orusingtobaccoproductsinareaswherecomponents,dietarysupplements,oranycontactsurfacesareexposed,orwherecontactsurfacesarewashed;andTakinganyotherprecautionsnecessarytoprotectagainstthecontaminationofcomponents,dietarysupplements,orcontactsurfaceswithmicroorganisms,filth,oranyotherextraneousmaterials,includingperspiration,hair,cosmetics,tobacco,chemicals,andmedicinesappliedtotheskin.料受到微生物或异物（Sec111.12Whatpersonnelqualificationrequirementsapply?Youmusthavequalifiedemployeeswhomanufacture,package,label,orholddietarysupplements.Youmustidentifywhoisresponsibleforyourqualitycontroloperations.Eachpersonwhoisidentifiedtoperformqualitycontroloperationsmustbequalifiedtodosoandhavedistinctandseparateresponsibilitiesrelatedtoperformingsuchoperationsfromthoseresponsibilitiesthatthepersonotherwisehaswhennotperformingsuchoperations.（experiencetoperformtheperson'sassignedfunctions.Sec.111.13Whatsupervisorrequirementsapply?Youmustassignqualifiedpersonneltosupervisethemanufacturing,packaging,labeling,orholdingofdietarysupplements.experiencetosupervise.Sec111.14UnderthissubpartBwhatrecordsmustyoumakeandkeep?在子部分B中，什么记录必须是你记录和保存的？YoumustmakeandkeeprecordsrequiredunderthissubpartBinaccordancewithsubpartPofthispart.你必须记录和保存在B部分的规定下P为实现BDocumentationoftraining,includingthedateofthetraining,thetypeoftraining,andtheperson(s)trained.SubpartC--PhysicalPlantandGroundsSec.111.15WhatsanitationrequirementsapplytoyourphysicalplantandGrounds.Youmustkeepthegroundsofyourphysicalplantinathatprotectsagainstthecontaminationofcomponents,dietarysupplements,orcontactsurfaces.Themethodsforadequategroundmaintenanceinclude:Properlystoringequipment,removinglitterandwaste,andcuttingweedsorgrasswithintheimmediatevicinityofthephysicalplantsothatitdoesnotattractpests,harborpests,orprovidepestsaplaceforbreeding;Maintainingroads,yards,andparkinglotssothattheydonotconstituteasourceofcontaminationinareaswherecomponents,dietarysupplements,orcontactsurfacesareexposed;Adequatelydrainingareasthatmaycontributetothecontaminationofcomponents,dietarysupplements,orcontactsurfacesbyseepage,filthoranyotherextraneousmaterials,orbyprovidingabreedingplaceforpests;Adequatelyoperatingsystemsforwastetreatmentanddisposalsothattheydonotconstituteasourceofcontaminationinareaswherecomponents,dietarysupplements,orcontactsurfacesareexposed;andifthoseothergroundsarenotmaintainedinthemannerdescribedinthissection,excludepests,dirt,andfilthoranyotherextraneousmaterialsthatmaybeasourceofcontamination.Physicalplantfacilities.（b）YoumustmaintainyourphysicalplantinacleanandsanitaryYoumustmaintainyourphysicalplantinrepairsufficientto 染。Cleaningcompounds,sanitizingagents,pesticides,andothertoxictheconditionsofuse.Youmustnotuseorholdtoxicmaterialsinaphysicalplantinwhichcomponents,dietarysupplements,orcontactsurfacesaremanufacturedorexposed,unlessthosematerialsarenecessaryasfollows:Foruseintheplant's(ivYoumustidentifyandholdcleaningcompounds,sanitizingagents,againstcontaminationofcomponents,dietarysupplements,orcontactsurfaces.YoumustnotallowanimalsorpestsinanyareaofyourphysicalGuardorguidedogsareallowedinsomeareasofyourphysicalplantifthepresenceofthedogswillnotresultincontaminationofcomponents,dietarysupplements,orcontactsurfaces;Youmusttakeeffectivemeasurestoexcludepestsfromthephysicalplantandtoprotectagainstcontaminationofcomponents,dietarysupplements,andcontactsurfacesonthepremisesbypests;andYoumustnotuseinsecticides,fumigants,fungicides,orrodenticides,unlessyoutakeprecautionstoprotectagainstthecontaminationofcomponents,dietarysupplements,orcontactsurfaces.供水Youmustprovidewaterthatissafeandsanitary,atsuitableandunderpressureasneeded,foralluseswherewaterdoesnotbecomeacomponentofthedietarysupplement.Waterthatisusedinamannersuchthatthewatermaybecomeacomponentofthedietarysupplement,e.g.,whensuchwatercontactscomponents,dietarysupplements,oranycontactsurface,must,ataminimum,thedietarysupplement.anddesignandbeadequatelyinstalledandmaintainedto:护：Carrysufficientamountsofwatertorequiredlocationsthroughoutthephysicalplant;ProperlyconveysewageandliquiddisposablewastefromyourphysicalAvoidbeingasourceofcontaminationtocomponents,dietarysupplements,watersupplies,oranycontactsurface,orcreatinganunsanitaryProvideadequatefloordrainageinallareaswherefloorsaresubjecttoflooding-typecleaningorwherenormaloperationsreleaseordischargewaterorotherliquidwasteonthefloor;anddischargewastewaterorsewageandpipingsystemsthatcarrywaterusedformanufacturingdietarysupplements,forcleaningcontactsurfaces,orforuseinbathroomsorhand-washingfacilities.Sewagedisposal.Youmustdisposeofsewageintoanadequatesewagesystemorthroughotheradequatemeans.Bathrooms.Youmustprovideyouremployeeswithadequate,readilyaccessiblebathrooms.ThebathroomsmustbekeptcleanandmustnotbeaHand-washingfacilities.Youmustprovidehand-washingfacilitiesthatarecomponents,dietarysupplements,oranycontactsurface,byprovidingfacilitiesthatareadequate,convenient,andfurnishrunningwateratasuitable洗手设施：必须提供洗手设施，所提供的洗手设施必须方便适用，具有适当温度的自Minimizethepotentialforthetrashtoattract,harbor,orbecomeabreedingplaceforpests;Protectagainstcontaminationofcomponents,dietarysupplements,anycontactsurface,watersupplies,andgroundssurroundingyourphysicalplant;andsupplements,andcontactsurfaces.Sanitationsupervisors.Youmustassignoneormoreemployeestosuperviseoverallsanitation.Eachofthesesupervisorsmustbequalifiedbyeducation,training,orexperiencetodevelopandsupervisesanitationSec.111.16WhataretherequirementsunderthissubpartCforwritten在C部分书面程序要求是什么？Youmustestablishandfollowwrittenproceduresforcleaningthephysicalplantandforpestcontrol.ofdietarysupplementsmust:Besuitableinsize,construction,anddesigntofacilitatemaintenance,cleaning,andsanitizingoperations;ofmaterialsasisnecessaryformaintenance,cleaning,andsanitizingoperationsandtopreventcontaminationandmixupsofcomponentsanddietarysupplementsduringmanufacturing,packaging,labeling,orholding;Permittheuseofproperprecautionstoreducethepotentialformixupsorcontaminationofcomponents,dietarysupplements,orcontactsurfaces,withmusthave,andyoumustuse,separateordefinedareasofadequatesizeorotherseparation,topreventcontaminationandmixupsofcomponentsanddietarysupplementsduringthefollowingoperations:Receiving,identifying,holding,andwithholdingfromuse,components,dietarysupplements,packaging,andlabelsthatwillbeusedinorduringthemanufacturing,packaging,labeling,orholdingofdietarysupplements;Separating,asnecessary,components,dietarysupplements,packaging,andlabelsthataretobeusedinmanufacturingfromcomponents,dietarysupplements,packaging,orlabelsthatareawaitingmaterialreviewanddispositiondecision,reprocessing,orareawaitingdisposalafterrejection;Separatingthemanufacturing,packaging,labeling,andholdingoffoods,cosmetics,andpharmaceuticalproducts;PerforminglaboratoryanalysesandholdinglaboratorysuppliesandBedesignedandconstructedinamannerthatpreventscontaminationofcomponents,dietarysupplements,orcontactsurfaces.Floors,walls,andceilingsthatcanbeadequatelycleanedandkeptcleanandingoodrepair;Fixtures,ducts,andpipesthatdonotcontaminatecomponents,dietarysupplements,orcontactsurfacesbydrippingorotherleakage,orcondensate;Adequateventilationorenvironmentalcontrolequipmentsuchasairflowsystems,includingfilters,fans,andotherair-blowingequipment,thatminimizeodorsandvapors(includingsteamandnoxiousfumes)inareaswheretheymaycontaminatecomponents,dietarysupplements,orcontactsurfaces;isnecessarytoensurethequalityofthedietarysupplement;andunobstructedandofadequatewidthtopermitallpersonstoperformtheirdutiesandtoprotectagainstcontaminationofcomponents,dietarysupplements,orcontactsurfaceswithclothingorpersonalcontact.(2)Whenfansandotherair-blowingequipmentareused,suchfansandformicroorganismsandparticulatemattertocontaminatecomponents,dietarysupplements,orcontactsurfaces;ProvideadequatelightAllareaswherecomponentsordietarysupplementsareexamined,processed,orheld;AllareaswherecontactsurfacesarecleanedandUsesafety-typelightbulbs,fixtures,skylights,orotherglassorglass-likematerialswhenthelightbulbs,fixtures,skylightsorotherglassorglass-likestepofpreparation,unlessyourphysicalplantisotherwiseconstructedinamannerthatwillprotectagainstcontaminationofcomponentsordietarysupplementsincaseofbreakageofglassorglass-likematerials.Provideeffectiveprotectionagainstcontaminationofcomponentsanddietarysupplementsinbulkfermentationvessels,by,forexample:Placementinareaswhereyoucaneliminateharboragesforpestsoverandaroundthevessels;filthoranyotherextraneousmaterials;andUseadequatescreeningorotherprotectionagainstpests,whereSec111.23UnderthissubpartCwhatrecordsmustyoumakeandkeep?在C部分，你必须制定和保存哪些记录？YoumustmakeandkeeprecordsrequiredunderthissubpartCinaccordancewithsubpartPofthispart.必须按照文中P部分要求完成并保存Cphysicalplantandforpestcontrol.Youmustmakeandkeeprecordsthatshowthatwater,whenusedinamannersuchthatthewatermaybecomeacomponentofthedietarysupplement,meetstherequirementsof111.15(e)(2).如果水作为膳食补充剂的一种组分，必须制定并保存用水满足111.15(e)(2SubpartD--EquipmentandUtensilsSec.111.25WhataretherequirementsunderthissubpartDforwrittenprocedures?在D子部分中对于书面程序有哪些要求？ requirementsofthissubpartD,includingwrittenproceduresfor:必须制定并遵循DCalibratinginstrumentsandcontrolsthatyouuseinmanufacturingortestingacomponentordietarysupplement;Calibrating,inspecting,andcheckingautomated,mechanical,andelectronicequipment;andMaintaining,cleaning,andsanitizing,asnecessary,allequipment,utensils,andanyothercontactsurfacesthatareusedtomanufacture,package,label,orholdcomponentsordietarysupplements.(c)必要时，对用于组分或膳食补充剂生产、包装、贴标或保存的所有设备、器具以Sec.111.27WhatrequirementsapplytotheequipmentandutensilsthatyouYoumustuseequipmentandutensilsthatareofappropriatedesign,construction,andworkmanshiptoenablethemtobesuitablefortheirintendeduseandtobeadequatelycleanedandproperlymaintained.EquipmentandutensilsincludetheEquipmentusedtoholdorEquipmentusingcompressedairorEquipmentusedinautomated,mechanical,orelectronic(vYoumustuseequipmentandutensilsofappropriatedesignandconstructionsothatusewillnotresultinthecontaminationofcomponentsordietarysupplementswith:必须使用设计及构造合理的设备及器具，以避免在使用下列物质时对组分或膳食MetalorglassContaminatedwater;AnyotherInstalledandmaintainedtofacilitatecleaningtheequipment,utensils,andalladjacentspaces;Corrosion-resistantiftheequipmentorutensilscontactcomponentsordietarysupplements;used,theactionofcomponentsordietarysupplements,and,ifapplicable,cleaningcompoundsandsanitizingagents;and其设计和构造应能经受其使用时所处的环境条件，组分或膳食补充剂的作用，以Maintainedtoprotectcomponentsanddietarysupplementsfrombeingcontaminatedbyanysource.(vEquipmentandutensilsyouusemusthaveseamsthataresmoothlybondedormaintainedtominimizeaccumulationofdirt,filth,organicmaterial,particlesofcomponentsordietarysupplements,oranyotherextraneousmaterialscomponentsordietarysupplements:Mustbefittedwithanindicatingthermometer,temperature-measuringdevice,ortemperature-recordingdevicethatindicatesandrecords,orallowsforrecordingbyhand,thetemperatureaccuratelywithinthecompartment;andMusthaveanautomateddeviceforregulatingtemperatureoranautomatedalarmsystemtoindicateasignificanttemperaturechangeinamanual(ii)Instrumentsorcontrolsusedinthemanufacturing,packaging,labeling,orholdingofadietarysupplement,andinstrumentsorcontrolsthatyouusetomeasure,regulate,orrecordtemperatures,hydrogen-ionconcentrationwateractivity,orotherconditions,tocontrolorpreventthegrowthofmicroorganismsorothercontaminationmustbe:膳食补充剂生产、包装、贴标或保存时使用的仪器或控制器，用于测量、调节或AccurateandAdequatelymaintained;Adequateinnumberfortheirdesignated(iiiCompressedairorothergasesyouintroducemechanicallyintoorontoacomponent,dietarysupplement,orcontactsurfaceorthatyouusetocleananycontactsurfacemustbetreatedinsuchawaythatthecomponent,dietarysupplement,orcontactsurfaceisnotcontaminated.通过机械方式引入到组分、膳食补充剂或接触面，或用于清洁接触面的压缩空气(b)Youmustcalibrateinstrumentsandcontrolsyouuseinmanufacturingortestingacomponentordietarysupplement.Youmustcalibrate:必须校准用于生产或测试组分或膳食补充剂的仪器及控制器。你必须进行校准工作：Beforefirstuse;Atthefrequencyspecifiedinwritingbythemanufactureroftheinstrumentandcontrol;orAtroutineintervalsorasotherwisenecessarytoensuretheaccuracyandprecisionoftheinstrumentandcontrol.toagreewiththereferencestandard.Youmustmaintain,clean,andsanitize,asnecessary,allequipment,andanyothercontactsurfacesusedtomanufacture,package,label,orholdcomponentsordietarysupplements.)对用于组分或膳食补充剂生产、包装、贴标或保存的所有设备、器具及任何其它Equipmentandutensilsmustbetakenapartasnecessaryforthoroughmaintenance,cleaning,andsanitizing.Youmustensurethatallcontactsurfaces,usedformanufacturingorholdinglow-moisturecomponentsordietarysupplements,areinadryandsanitarywhennecessary,andthoroughlydriedbeforesubsequentuse.用于生产或保存低水分含量组分或膳食补充剂的所有接触面，在使用时必须确保燥。Ifyouusewetprocessingduringmanufacturing,youmustcleanandsanitizeallcontactsurfaces,asnecessary,toprotectagainsttheintroductionofmicroorganismsintocomponentsordietarysupplements.Whencleaningandsanitizingisnecessary,youmustcleanandsanitizeallcontactsurfacesbeforeuseandafteranyinterruptionduringwhichthecontactsurfacemayhaveinconsecutiveoperationsinvolvingdifferentbatchesofthesamedietarysupplement,youmustadequatelycleanandsanitizethecontactsurfaces,as如果在生产过程中运用了湿处理，必要时，则必须对所有接触面进行清洁消毒，Youmustcleansurfacesthatdonotcomeintodirectcontactwithcomponentsordietarysupplementsasfrequentlyasnecessarytoprotectagainstcontaminatingcomponentsordietarysupplements.必须按必要的频率清洁未与组分或膳食补充剂直接接触的表面，以防止污染组分Single-servicearticles(suchasutensilsintendedforone-timeuse,papercups,andpapertowels)mustbe:一次性物品（如一次性使用的器具、纸杯和纸巾）(i)Storedinappropriatecontainers;Handled,dispensed,used,anddisposedofinamannerthatprotectsagainstcontaminationofcomponents,dietarysupplements,oranycontact)搬运、分发、使用和报废处理方式应当防止组分、膳食补充剂或其它任何接触面Cleaningcompoundsandsanitizingagentsmustbeadequatefortheirintendeduseandsafeundertheirconditionsofuse;必须备有足量清洁剂、消毒剂用于预订的用途，且必须保证正常使用条件下的安全；havecontactsurfacesinalocationandmannerthatprotectsthemfrom)具有接触面、经过清洁消毒的便携式设备和器具，其存放位置和方式必须能够防[72FR34942,June25,2007,asamendedat73FR13124,Mar.12,[2007年6月25日颁布了72FR34942，2008年3月1273FR13124Foranyautomated,mechanical,orelectronicequipmentthatyouusetomanufacture,package,label,orholdadietarysupplement,youmust:(a)Designorselectequipmenttoensurethatdietarysupplementspecificationsareconsistentlymet;Determinethesuitabilityoftheequipmentbyensuringthatyourequipmentiscapableofoperatingsatisfactorilywithintheoperatinglimitsrequiredbytheprocess;Routinelycalibrate,inspect,orchecktheequipmenttoensureproperperformance.Yourqualitycontrolpersonnelmustperiodicallyreviewthesecalibrations,inspections,orchecks;对设备进行定期校准、检查或检验，确保其正常运行，质量控制人员必须定期评Establishanduseappropriatecontrolsforautomated,mechanical,andelectronicequipment(includingsoftwareforacomputercontrolledprocess)toensurethatanychangestothemanufacturing,packaging,labeling,holding,orotheroperationsareapprovedbyqualitycontrolpersonnelandinstitutedonlybyauthorizedpersonnel;and制定并采用适于自动化、机械以及电子设备（包括计算机控制程序的软件）的控Establishanduseappropriatecontrolstoensurethattheequipmentqualitycontrolpersonnel.(e)制定并采用适当的控制程序，确保设备按照预期的用途正常发挥作用，这些控制Sec111.35UnderthissubpartDwhatrecordsmustyoumakeandkeep?在D节中，必须建立并保存哪些记录？YoumustmakeandkeeprecordsrequiredunderthissubpartD必须按照文中P节要求建立并保存Dwrittenproceduresfor:(i)Calibratinginstrumentsandcontrolsthatyouuseinmanufacturingortestingacomponentordietarysupplement;Calibrating,inspecting,andcheckingautomated,mechanical,andelectronicequipment;andandanyothercontactsurfacesthatareusedtomanufacture,package,label,orholdcomponentsordietarysupplements;(iiiDocumentation,inindividualequipmentlogs,ofthedateoftheuse,keptwiththebatchrecord;Documentationofanycalibration,eachtimethecalibrationisperformed,forinstrumentsandcontrolsthatyouuseinmanufacturingortestingacomponentordietarysupplement.Inyourdocumentation,youmust:对于生产、测试组分、膳食补充剂的仪器及控制设备，记录每一次校准时间。在Providethedateofoftheknownreferencestandardandahistoryofrecertificationofaccuracy;Identifythecalibrationmethodused,includingappropriatelimitsforaccuracyandprecisionofinstrumentsandcontrolswhencalibrating;ProvidethecalibrationreadingorreadingsIdentifytherecalibrationmethodused,andreadingorreadingsfound,ifaccuracyorprecisionorbothaccuracyandprecisionlimitsforinstrumentsandcontrolswerenotmet;and如果仪器及控制设备的精确性和准确性条件，或精确性和准确性的限制条件均未Includetheinitialsofthepersonwhoperformedthecalibrationandany(viiWrittenrecordsofcalibrations,inspections,andchecksofautomated,mechanical,andelectronicequipment;isnecessarytoretrieverecordsthatyouarerequiredtokeepinaccordancewithsubpartPofthispart,whencurrentsoftwareisnotabletoretrieve