QSR820e.docx
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QSR820e.docx
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QSR820e
21CFR§820
QualitySystemRegulation
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.
SubpartN—Servicing
820.200Servicing.
SubpartO—StatisticalTechniques
820.250Statisticaltechniques.
Authority:
Secs.501,502,510,513,514,515,518,519,520,522,701,704,801,803oftheFederalFood,Drug,andCosmeticAct(21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383).
SubpartA—GeneralProvisions
§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,designcontrolsapplyonlytothosedeviceslistedin§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.Petitionsforanexemptionorvarianceshallbesubmittedaccordingtotheproceduressetforthin§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.
§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-processdevi
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