CRF 21 Part 111 膳食補(bǔ)充劑GMP規(guī)范中英文對(duì)照

[Title21,Volume2][RevisedasofApril1,2015][CITE:21CFR111]TITLE21--FOODANDCHAPTERI--FOODANDDRUGADMINISTRATIONDEPARTMENTOFHEALTHANDHUMANSERVICESSUBCHAPTERB--FOODFORHUMANCONSUMPTIONPART111 CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PACKAGING,LABELING,ORHOLDINGOPERATIONSFORDIETARY第111部分飲食添加劑生產(chǎn)、包裝、標(biāo)簽和儲(chǔ)藏操作的CGMP規(guī)范SubpartA--GeneralProvisions一般規(guī)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:聯(lián)邦食品、藥品和化妝品法案（該法案）第201節(jié)中的定義和術(shù)語(yǔ)解釋適用于此部分Actualyieldmeansthequantitythatisactuallyproducedatanyappropriatestepofmanufactureorpackagingofaparticulardietarysupplement.thatisproducedduringaspecifiedtimeperiodaccordingtoasinglemanufacturingrecordduringthesamecycleofmanufacture.批是指在規(guī)定限度內(nèi)具有同一性質(zhì)和質(zhì)量,并在同一連續(xù)生產(chǎn)周期中生產(chǎn)出來(lái)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).電子或口頭形式提出意見(jiàn)的一切包含任何主張的通信。產(chǎn)品投訴實(shí)例包括：惡臭、變味、疾病或傷害、分解時(shí)間、變色、片劑大小或大小變化、容器未滿(mǎn)、膳食補(bǔ)充劑容器內(nèi)有異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代表性樣品是指根據(jù)合理標(biāo)準(zhǔn)確定（如隨機(jī)抽樣）uncontaminatedcomponentsordietarysupplementsthathavebeenpreviouslyremovedfrommanufacturingandthathavebeenmadesuitableforuseinthemanufactureofadietarysupplement.程中。Reservesamplemeansarepresentativesampleofproductthatisheldforadesignatedperiodoftime.anyothercleanedcontactsurfacebyaprocessthatiseffectiveindestroyingvegetativecellsofmicroorganismsofpublichealthsignificance,andinsubstantiallyreducingnumbersofothermicroorganisms,butwithoutadverselyTheoreticalyieldmeansthequantitythatwouldbeproducedatanyappropriatestepofmanufactureorpackagingofaparticulardietarysupplement,baseduponthequantityofcomponentsorpackagingtobeused,intheabsenceofanylossorerrorinactualproduction.supplementandisthequotientofthewatervaporpressureofthesubstancedividedbythevaporpressureofpurewateratthesametemperature.WemeanstheU.SFoodandDrugAdministration(FDA).Youmeansapersonwhomanufactures,packages,labels,orholdsInadditiontothispart,youmustcomplywithotherapplicablestatutoryprovisionsandregulationsundertheactrelatedtodietarysupplements.人員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.如果員工有或者可能有a部分（1）中所述的可能導(dǎo)致產(chǎn)品主成分、膳食補(bǔ)充劑Hygienicpractices.Ifyouworkinanoperationduringwhichadulterationofthecomponent,dietarysupplement,orcontactsurfacecouldoccur,youmustusehygienicpracticestotheextentnecessarytoprotectagainstsuchcontaminationofcomponents,dietarysupplements,orcontactsurfaces.Thesehygienicpracticesincludethefollowing:Wearingoutergarmentsinamannerthatprotectsagainstthecontaminationofcomponents,dietarysupplements,oranycontactsurface;MaintainingadequatepersonalWashinghandsthoroughly(andsanitizingifnecessarytoprotectagainstcontaminationwithmicroorganisms)inanadequatehand-washingfacility:用適當(dāng)?shù)南词衷O(shè)施徹底洗手（如有必要需進(jìn)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（如果用它們處理膳食補(bǔ)充劑）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.料受到微生物或異物（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，什么記錄必須是你記錄和保存的？YoumustmakeandkeeprecordsrequiredunderthissubpartBinaccordancewithsubpartPofthispart.你必須記錄和保存在B部分的規(guī)定下P為實(shí)現(xiàn)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:護(hù)：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洗手設(shè)施：必須提供洗手設(shè)施，所提供的洗手設(shè)施必須方便適用，具有適當(dāng)溫度的自Minimizethepotentialforthetrashtoattract,harbor,orbecomeabreedingplaceforpests;Protectagainstcontaminationofcomponents,dietarysupplements,anycontactsurface,watersupplies,andgroundssurroundingyourphysicalplant;andsupplements,andcontactsurfaces.Sanitationsupervisors.Youmustassignoneormoreemployeestosuperviseoverallsanitation.Eachofthesesupervisorsmustbequalifiedbyeducation,training,orexperiencetodevelopandsupervisesanitationSec.111.16WhataretherequirementsunderthissubpartCforwritten在C部分書(shū)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，你必須制定和保存哪些記錄？YoumustmakeandkeeprecordsrequiredunderthissubpartCinaccordancewithsubpartPofthispart.必須按照文中P部分要求完成并保存Cphysicalplantandforpestcontrol.Youmustmakeandkeeprecordsthatshowthatwater,whenusedinamannersuchthatthewatermaybecomeacomponentofthedietarysupplement,meetstherequirementsof111.15(e)(2).如果水作為膳食補(bǔ)充劑的一種組分，必須制定并保存用水滿(mǎn)足111.15(e)(2SubpartD--EquipmentandUtensilsSec.111.25WhataretherequirementsunderthissubpartDforwrittenprocedures?在D子部分中對(duì)于書(shū)面程序有哪些要求？ requirementsofthissubpartD,includingwrittenproceduresfor:必須制定并遵循DCalibratinginstrumentsandcontrolsthatyouuseinmanufacturingortestingacomponentordietarysupplement;Calibrating,inspecting,andcheckingautomated,mechanical,andelectronicequipment;andMaintaining,cleaning,andsanitizing,asnecessary,allequipment,utensils,andanyothercontactsurfacesthatareusedtomanufacture,package,label,orholdcomponentsordietarysupplements.(c)必要時(shí)，對(duì)用于組分或膳食補(bǔ)充劑生產(chǎn)、包裝、貼標(biāo)或保存的所有設(shè)備、器具以Sec.111.27WhatrequirementsapplytotheequipmentandutensilsthatyouYoumustuseequipmentandutensilsthatareofappropriatedesign,construction,andworkmanshiptoenablethemtobesuitablefortheirintendeduseandtobeadequatelycleanedandproperlymaintained.EquipmentandutensilsincludetheEquipmentusedtoholdorEquipmentusingcompressedairorEquipmentusedinautomated,mechanical,orelectronic(vYoumustuseequipmentandutensilsofappropriatedesignandconstructionsothatusewillnotresultinthecontaminationofcomponentsordietarysupplementswith:必須使用設(shè)計(jì)及構(gòu)造合理的設(shè)備及器具，以避免在使用下列物質(zhì)時(shí)對(duì)組分或膳食MetalorglassContaminatedwater;AnyotherInstalledandmaintainedtofacilitatecleaningtheequipment,utensils,andalladjacentspaces;Corrosion-resistantiftheequipmentorutensilscontactcomponentsordietarysupplements;used,theactionofcomponentsordietarysupplements,and,ifapplicable,cleaningcompoundsandsanitizingagents;and其設(shè)計(jì)和構(gòu)造應(yīng)能經(jīng)受其使用時(shí)所處的環(huán)境條件，組分或膳食補(bǔ)充劑的作用，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:膳食補(bǔ)充劑生產(chǎn)、包裝、貼標(biāo)或保存時(shí)使用的儀器或控制器，用于測(cè)量、調(diào)節(jié)或AccurateandAdequatelymaintained;Adequateinnumberfortheirdesignated(iiiCompressedairorothergasesyouintroducemechanicallyintoorontoacomponent,dietarysupplement,orcontactsurfaceorthatyouusetocleananycontactsurfacemustbetreatedinsuchawaythatthecomponent,dietarysupplement,orcontactsurfaceisnotcontaminated.通過(guò)機(jī)械方式引入到組分、膳食補(bǔ)充劑或接觸面，或用于清潔接觸面的壓縮空氣(b)Youmustcalibrateinstrumentsandcontrolsyouuseinmanufacturingortestingacomponentordietarysupplement.Youmustcalibrate:必須校準(zhǔn)用于生產(chǎn)或測(cè)試組分或膳食補(bǔ)充劑的儀器及控制器。你必須進(jìn)行校準(zhǔn)工作：Beforefirstuse;Atthefrequencyspecifiedinwritingbythemanufactureroftheinstrumentandcontrol;orAtroutineintervalsorasotherwisenecessarytoensuretheaccuracyandprecisionoftheinstrumentandcontrol.toagreewiththereferencestandard.Youmustmaintain,clean,andsanitize,asnecessary,allequipment,andanyothercontactsurfacesusedtomanufacture,package,label,orholdcomponentsordietarysupplements.)對(duì)用于組分或膳食補(bǔ)充劑生產(chǎn)、包裝、貼標(biāo)或保存的所有設(shè)備、器具及任何其它Equipmentandutensilsmustbetakenapartasnecessaryforthoroughmaintenance,cleaning,andsanitizing.Youmustensurethatallcontactsurfaces,usedformanufacturingorholdinglow-moisturecomponentsordietarysupplements,areinadryandsanitarywhennecessary,andthoroughlydriedbeforesubsequentuse.用于生產(chǎn)或保存低水分含量組分或膳食補(bǔ)充劑的所有接觸面，在使用時(shí)必須確保燥。Ifyouusewetprocessingduringmanufacturing,youmustcleanandsanitizeallcontactsurfaces,asnecessary,toprotectagainsttheintroductionofmicroorganismsintocomponentsordietarysupplements.Whencleaningandsanitizingisnecessary,youmustcleanandsanitizeallcontactsurfacesbeforeuseandafteranyinterruptionduringwhichthecontactsurfacemayhaveinconsecutiveoperationsinvolvingdifferentbatchesofthesamedietarysupplement,youmustadequatelycleanandsanitizethecontactsurfaces,as如果在生產(chǎn)過(guò)程中運(yùn)用了濕處理，必要時(shí)，則必須對(duì)所有接觸面進(jìn)行清潔消毒，Youmustcleansurfacesthatdonotcomeintodirectcontactwithcomponentsordietarysupplementsasfrequentlyasnecessarytoprotectagainstcontaminatingcomponentsordietarysupplements.必須按必要的頻率清潔未與組分或膳食補(bǔ)充劑直接接觸的表面，以防止污染組分Single-servicearticles(suchasutensilsintendedforone-timeuse,papercups,andpapertowels)mustbe:一次性物品（如一次性使用的器具、紙杯和紙巾）(i)Storedinappropriatecontainers;Handled,dispensed,used,anddisposedofinamannerthatprotectsagainstcontaminationofcomponents,dietarysupplements,oranycontact)搬運(yùn)、分發(fā)、使用和報(bào)廢處理方式應(yīng)當(dāng)防止組分、膳食補(bǔ)充劑或其它任何接觸面Cleaningcompoundsandsanitizingagentsmustbeadequatefortheirintendeduseandsafeundertheirconditionsofuse;必須備有足量清潔劑、消毒劑用于預(yù)訂的用途，且必須保證正常使用條件下的安全；havecontactsurfacesinalocationandmannerthatprotectsthemfrom)具有接觸面、經(jīng)過(guò)清潔消毒的便攜式設(shè)備和器具，其存放位置和方式必須能夠防[72FR34942,June25,2007,asamendedat73FR13124,Mar.12,[2007年6月25日頒布了72FR34942，2008年3月1273FR13124Foranyautomated,mechanical,orelectronicequipmentthatyouusetomanufacture,package,label,orholdadietarysupplement,youmust:(a)Designorselectequipmenttoensurethatdietarysupplementspecificationsareconsistentlymet;Determinethesuitabilityoftheequipmentbyensuringthatyourequipmentiscapableofoperatingsatisfactorilywithintheoperatinglimitsrequiredbytheprocess;Routinelycalibrate,inspect,orchecktheequipmenttoensureproperperformance.Yourqualitycontrolpersonnelmustperiodicallyreviewthesecalibrations,inspections,orchecks;對(duì)設(shè)備進(jìn)行定期校準(zhǔn)、檢查或檢驗(yàn)，確保其正常運(yùn)行，質(zhì)量控制人員必須定期評(píng)Establishanduseappropriatecontrolsforautomated,mechanical,andelectronicequipment(includingsoftwareforacomputercontrolledprocess)toensurethatanychangestothemanufacturing,packaging,labeling,holding,orotheroperationsareapprovedbyqualitycontrolpersonnelandinstitutedonlybyauthorizedpersonnel;and制定并采用適于自動(dòng)化、機(jī)械以及電子設(shè)備（包括計(jì)算機(jī)控制程序的軟件）的控Establishanduseappropriatecontrolstoensurethattheequipmentqualitycontrolpersonnel.(e)制定并采用適當(dāng)?shù)目刂瞥绦?，確保設(shè)備按照預(yù)期的用途正常發(fā)揮作用，這些控制Sec111.35UnderthissubpartDwhatrecordsmustyoumakeandkeep?在D節(jié)中，必須建立并保存哪些記錄？YoumustmakeandkeeprecordsrequiredunderthissubpartD必須按照文中P節(jié)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:對(duì)于生產(chǎn)、測(cè)試組分、膳食補(bǔ)充劑的儀器及控制設(shè)備，記錄每一次校準(zhǔn)時(shí)間。在Providethedateofoftheknownreferencestandardandahistoryofrecertificationofaccuracy;Identifythecalibrationmethodused,includingappropriatelimitsforaccuracyandprecisionofinstrumentsandcontrolswhencalibrating;ProvidethecalibrationreadingorreadingsIdentifytherecalibrationmethodused,andreadingorreadingsfound,ifaccuracyorprecisionorbothaccuracyandprecisionlimitsforinstrumentsandcontrolswerenotmet;and如果儀器及控制設(shè)備的精確性和準(zhǔn)確性條件，或精確性和準(zhǔn)確性的限制條件均未Includetheinitialsofthepersonwhoperformedthecalibrationandany(viiWrittenrecordsofcalibrations,inspections,andchecksofautomated,mechanical,andelectronicequipment;isnecessarytoretrieverecordsthatyouarerequiredtokeepinaccordancewithsubpartPofthispart,whencurrentsoftwareisnotabletoretrieve