21CFR820 Quality System RegulationWord文档格式.docx
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21CFR820 Quality System RegulationWord文档格式.docx
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PART820QUALITYSYSTEMREGULATION
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,designcontrolsapplyonlytothosedeviceslistedin820.30(a)
(2).Thisregulationdoesnotapplytomanufacturersofcomponentsorpartsoffinisheddevices,butsuchmanufacturersareencouragedtouseappropriateprovisionsofthisregulationasguidance.Manufacturersofhumanbloodandbloodcomponentsarenotsubjecttothispart,butaresubjecttopart606ofthischapter.Manufacturersofhumancells,tissues,andcellularandtissue-basedproducts(HCT/Ps),asdefinedin1271.3(d)ofthischapter,thataremedicaldevices(subjecttopremarketreviewornotification,orexemptfromnotification,underanapplicationsubmittedunderthedeviceprovisionsoftheactorunderabiologicalproductlicenseapplicationundersection351ofthePublicHealthServiceAct)aresubjecttothispartandarealsosubjecttothedonor-eligibilityproceduressetforthinpart1271subpartCofthischapterandapplicablecurrentgoodtissuepracticeproceduresinpart1271subpartDofthischapter.Intheeventofaconflictbetweenapplicableregulationsinpart1271andinotherpartsofthischapter,theregulationspecificallyapplicabletothedeviceinquestionshallsupersedethemoregeneral.
(2)Theprovisionsofthispartshallbeapplicabletoanyfinisheddeviceasdefinedinthispart,intendedforhumanuse,thatismanufactured,imported,orofferedforimportinanyStateorTerritoryoftheUnitedStates,theDistrictofColumbia,ortheCommonwealthofPuertoRico.
(3)Inthisregulationtheterm"
whereappropriate"
isusedseveraltimes.Whenarequirementisqualifiedby"
whereappropriate,"
itisdeemedtobe"
appropriate"
unlessthemanufacturercandocumentjustificationotherwise.Arequirementis"
ifnonimplementationcouldreasonablybeexpectedtoresultintheproductnotmeetingitsspecifiedrequirementsorthemanufacturernotbeingabletocarryoutanynecessarycorrectiveaction.
(b)scope.
Thequalitysystemregulationinthispartsupplementsregulationsinotherpartsofthischapterexceptwhereexplicitlystatedotherwise.Intheeventofaconflictbetweenapplicableregulationsinthispartandinotherpartsofthischapter,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.Petitionsforanexemptionorvarianceshallbesubmittedaccordingtotheproceduressetforthin10.30ofthischapter,theFDA'
sadministrativeprocedures.GuidanceisavailablefromtheFoodandDrugAdministration,CenterforDevicesandRadiologicalHealth,DivisionofSmallManufacturers,InternationalandConsumerAssistance,10903NewHampshireAve.,Bldg.66,rm.4613,SilverSpring,MD20993-0002,1-800-638-2041or301-796-7100,FAX:
301-847-8149.
(2)FDAmayinitiateandgrantavariancefromanydevicequalitysystemrequirementwhentheagencydeterminesthatsuchvarianceisinthebestinterestofthepublichealth.Suchvariancewillremainineffectonlysolongasthereremainsapublichealthneedforthedeviceandthedevicewouldnotlikelybemadesufficientlyavailablewithoutthevariance.
[61FR52654,Oct.7,1996,asamendedat65FR17136,Mar.31,2000;
65FR66636,Nov.7,2000;
69FR29829,May25,2005;
72FR17399,Apr.9,2007;
75FR20915,Apr.22,2010]
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)Nonconformitymeansthenonfulfillmentofaspecifiedrequirement.
(r)Productmeanscomponents,manufacturingmaterials,in-processdevices,finisheddevices,andreturneddevices.
(s)Qualitymeansthetotalityoffeaturesandcharacteristicsthatbearontheabilityofadevicetosatisfyfitness-for-use,includingsafetyandperformance.
(t)Qualityauditmeansasystematic,independentexaminationofamanufacturer'
squalitysystemthatisperformedatdefinedintervalsandatsufficientfrequencytodeterminewhetherbothqualitysystemactivitiesandtheresultsofsuchactivi
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