820英文版.docx
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820英文版.docx
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820英文版
21CFR820-Qualitysystemregulation
[CodeofFederalRegulations]
[Title21,Volume8]
[RevisedasofApril1,2001]
FromtheU.S.GovernmentPrintingOfficeviaGPOAccess
TITLE21--FOODANDDRUGS
CHAPTERI--FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMAN
SERVICES--(Continued)
PART820--QUALITYSYSTEMREGULATION--TableofContents
SubpartA-GeneralProvisions
820.1Scope
820.3Definitions
820.5Qualitysystem
SubpartB-QualitySystemRequirements
820.20Managementresponsibility
820.22QualityAudit
820.25Personnel
SubpartC-DesignControls
820.30Designcontrols
SubpartD-DocumentControls
820.40Documentcontrols
SubpartE-PurchasingControls
820.50Purchasingcontrols
SubpartF-IdentificationandTraceability
820.60Identification
820.65Traceability
SubpartG-ProductionandProcessControls
820.70Productionandprocesscontrols
820.72Inspection,measuring,andtestequipment
820.75Processvalidation
SubpartH-AcceptanceActivities
820.80Receiving,in-process,andfinisheddeviceacceptance
820.86Acceptancestatus
SubpartI-NonconformingProduct
820.90Nonconformingproduct
SubpartJ-CorrectiveandPreventiveAction
820.100Correctiveandpreventiveaction
SubpartK-LabelingandPackagingControl
820.120Devicelabeling
820.130Devicepackaging
SubpartL-Handling,Storage,Distribution,andInstallation
820.140Handling
820.150Storage
820.160Distribution
820.170Installation
SubpartM–Records
820.180Generalrequirements
820.181Devicemasterrecord
820.184Devicehistoryrecord
820.186Qualitysystemrecord
820.198Complaintfiles
820.200Servicing
SubpartO-StatisticalTechniques
820.250Statisticaltechniques
SubpartA--GeneralProvisions
Sec.820.1Scope.
(a)Applicability.
(1)Currentgoodmanufacturingpractice(CGMP)requirementsaresetforthinthisqualitysystemregulation.Therequirementsinthispartgovernthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,andservicingofallfinisheddevicesintendedforhumanuse.TherequirementsinthispartareintendedtoensurethatfinisheddeviceswillbesafeandeffectiveandotherwiseincompliancewiththeFederalFood,Drug,andCosmeticAct(theact).Thispartestablishesbasicrequirementsapplicabletomanufacturersoffinishedmedicaldevices.Ifamanufacturerengagesinonlysomeoperationssubjecttotherequirementsinthispart,andnotinothers,thatmanufacturerneedonlycomplywiththoserequirementsapplicabletotheoperationsinwhichitisengaged.WithrespecttoclassIdevices,designcontrolsapplyonlytothosedeviceslistedinSec.820.30(a)
(2).Thisregulationdoesnotapplytomanufacturersofcomponentsorpartsoffinisheddevices,butsuchmanufacturersareencouragedtouseappropriateprovisionsofthisregulationasguidance.Manufacturersofhumanbloodandbloodcomponentsarenotsubjecttothispart,butaresubjecttopart606ofthischapter.
(2)Theprovisionsofthispartshallbeapplicabletoanyfinisheddeviceasdefinedinthispart,intendedforhumanuse,thatismanufactured,imported,orofferedforimportinanyStateorTerritoryoftheUnitedStates,theDistrictofColumbia,ortheCommonwealthofPuertoRico.
(3)Inthisregulationtheterm``whereappropriate''isusedseveraltimes.Whenarequirementisqualifiedby``whereappropriate,''itisdeemedtobe``appropriate''unlessthemanufacturercandocumentjustificationotherwise.Arequirementis``appropriate''ifnonimplementationcouldreasonablybeexpectedtoresultintheproductnotmeetingitsspecifiedrequirementsorthemanufacturernotbeingabletocarryoutanynecessarycorrectiveaction.
(b)Limitations.Thequalitysystemregulationinthispartsupplementsregulationsinotherpartsofthischapterexceptwhereexplicitlystatedotherwise.Intheeventthatitisimpossibletocomplywithallapplicableregulations,bothinthispartandinotherpartsofthischapter,theregulationsspecificallyapplicabletothedeviceinquestionshallsupersedeanyothergenerallyapplicablerequirements.
(c)Authority.Part820isestablishedandissuedunderauthorityofsections501,502,510,513,514,515,518,519,520,522,701,704,801,803oftheact(21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383).Thefailuretocomplywithanyapplicableprovisioninthispartrendersadeviceadulteratedundersection501(h)oftheact.Suchadevice,aswellasanypersonresponsibleforthefailuretocomply,issubjecttoregulatoryaction.
(d)Foreignmanufacturers.IfamanufacturerwhooffersdevicesforimportintotheUnitedStatesrefusestopermitorallowthecompletionofaFoodandDrugAdministration(FDA)inspectionoftheforeignfacilityforthepurposeofdeterminingcompliancewiththispart,itshallappearforpurposesofsection801(a)oftheact,thatthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,orservicingofanydevicesproducedatsuchfacilitythatareofferedforimportintotheUnitedStatesdonotconformtotherequirementsofsection520(f)oftheactandthispartandthatthedevicesmanufacturedatthatfacilityareadulteratedundersection501(h)oftheact.
(e)Exemptionsorvariances.
(1)Anypersonwhowishestopetitionforanexemptionorvariancefromanydevicequalitysystemrequirementissubjecttotherequirementsofsection520(f)
(2)oftheact.PetitionsforanexemptionorvarianceshallbesubmittedaccordingtotheproceduressetforthinSec.10.30ofthischapter,theFDA'sadministrativeprocedures.GuidanceisavailablefromtheCenterforDevicesandRadiologicalHealth,DivisionofSmallManufacturersAssistance(HFZ-220),1350PiccardDr.,Rockville,MD20850,U.S.A.,telephone1-800-638-2041or1-301-443-6597,FAX301-443-8818.
(2)FDAmayinitiateandgrantavariancefromanydevicequalitysystemrequirementwhentheagencydeterminesthatsuchvarianceisinthebestinterestofthepublichealth.Suchvariancewillremainineffectonlysolongasthereremainsapublichealthneedforthedeviceandthedevicewouldnotlikelybemadesufficientlyavailablewithoutthevariance.
Sec.820.3Definitions.
(a)ActmeanstheFederalFood,Drug,andCosmeticAct,asamended(secs.201-903,52Stat.1040etseq.,asamended(21U.S.C.321-394)).Alldefinitionsinsection201oftheactshallapplytotheregulationsinthispart.
(b)Complaintmeansanywritten,electronic,ororalcommunicationthatallegesdeficienciesrelatedtotheidentity,quality,durability,reliability,safety,effectiveness,orperformanceofadeviceafteritisreleasedfordistribution.
(c)Componentmeansanyrawmaterial,substance,piece,part,software,firmware,labeling,orassemblywhichisintendedtobeincludedaspartofthefinished,packaged,andlabeleddevice.
(d)Controlnumbermeansanydistinctivesymbols,suchasadistinctivecombinationoflettersornumbers,orboth,fromwhichthehistoryofthemanufacturing,packaging,labeling,anddistributionofaunit,lot,orbatchoffinisheddevicescanbedetermined.
(e)Designhistoryfile(DHF)meansacompilationofrecordswhichdescribesthedesignhistoryofafinisheddevice.
(f)Designinputmeansthephysicalandperformancerequirementsofadevicethatareusedasabasisfordevicedesign.
(g)Designoutputmeanstheresultsofadesigneffortateachdesignphaseandattheendofthetotaldesigneffort.Thefinisheddesignoutputisthebasisforthedevicemasterrecord.Thetotalfinisheddesignoutputconsistsofthedevice,itspackagingandlabeling,andthedevicemasterrecord.
(h)Designreviewmeansadocumented,comprehensive,systematicexaminationofadesigntoevaluatetheadequacyofthedesignrequirements,toevaluatethecapabilityofthedesigntomeettheserequirements,andtoidentifyproblems.
(i)Devicehistoryrecord(DHR)meansacompilationofrecordscontainingtheproductionhistoryofafinisheddevice.
(j)Devicemasterrecord(DMR)meansacompilationofrecordscontainingtheproceduresandspecificationsforafinisheddevice.
(k)Establishmeansdefine,document(inwritingorelectronically),andimplement.
(l)Finisheddevicemeansanydeviceoraccessorytoanydevicethatissuitableforuseorcapableoffunctioning,whetherornotitispackaged,labeled,orsterilized.
(m)Lotorbatchmeansoneormorecomponentsorfinisheddevicesthatconsistofasingletype,model,class,size,composition,orsoftwareversionthataremanufacturedunderessentiallythesameconditionsandthatareintendedtohaveuniformcharacteristicsandqualitywithinspecifiedlimits.
(n)Managementwithexecutiveresponsibilitymeansthosesenioremployeesofamanufacturerwhohavetheauthoritytoestablishormakechangestothemanufacturer'squalitypolicyandqualitysystem.
(o)Manufacturermeansanypersonwhodesigns,manufactures,fabricates,assembles,orprocessesafinisheddevice.Manufacturerincludesbutisnotlimitedtothosewhoperformthefunctionsofcontractsterilization,installation,relabeling,remanufacturing,repacking,orspecificationdevelopment,andinitialdistributorsofforeignentitiesperformingthesefunctions.
(p)Manufacturingmaterialmeansanymaterialorsubstanceusedinorusedtofacilitatethemanufacturingprocess,aconcomitantconstituent,orabyproductconstituentproducedduringthemanufacturingprocess,whichispresentinoronthefinisheddeviceasaresidueorimpuritynotbydesignorintentofthemanufacturer.
(q
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