21CFR 820 质量体系法规English + Chinese.docx
- 文档编号:26266728
- 上传时间:2023-06-17
- 格式:DOCX
- 页数:41
- 大小:46.78KB
21CFR 820 质量体系法规English + Chinese.docx
《21CFR 820 质量体系法规English + Chinese.docx》由会员分享,可在线阅读,更多相关《21CFR 820 质量体系法规English + Chinese.docx(41页珍藏版)》请在冰豆网上搜索。
21CFR820质量体系法规English+Chinese
§820.1-Scope.
§820.3-Definitions.
§820.5-Qualitysystem.
§820.20-Managementresponsibility.
§820.22-Qualityaudit.
§820.25-Personnel.§820.30-Designcontrols.
§820.40-Documentcontrols.
§820.50-Purchasingcontrols.
§820.60-Identification.
§820.65-Traceability.
§820.70-Productionandprocesscontrols.
§820.72-Inspection,measuring,andtestequipment.
§820.75-Processvalidation.
§820.80-Receiving,in-process,andfinisheddeviceacceptance.
§820.86-Acceptancestatus.
§820.90-Nonconformingproduct.
§820.100-Correctiveandpreventiveaction.
§820.120-Devicelabeling.
§820.130-Devicepackaging.
§820.140-Handling.
§820.150-Storage.
§820.160-Distribution.
§820.170-Installation.
§820.180-Generalrequirements.
§820.181-Devicemasterrecord.
§820.184-Devicehistoryrecord.
§820.186-Qualitysystemrecord.
§820.198-Complaintfiles.
§820.200-Servicing.
§820.250-Statisticaltechniques.
820.1范围
820.3定义
820.5质量体系
820.20管理职责
820.22质量审核
820.25人员
820.30设计控制
820.40文件控制
820.50采购控制
820.60标识
820.65可追溯性
820.70生产和过程控制
820.72检验、测量和试验设备
820.75过程确认
820.80进货、过程和最终产品检验
820.86检验状态
820.90不合格品
820.100纠正和预防措施
820.120设备标签
820.130设备包装
820.140搬运
820.150贮存
820.160交付/销售
820.170安装
820.180记录的通用要求
820.181设备主要记录
820.184设备历史记录
820.186质量体系记录
820.198投诉文件
820.200服务
820.250统计技术
SubpartA--GeneralProvisions
SubpartA——通用要求
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"appropriate"ifnonimplementationcouldreasonablybeexpectedtoresultintheproductnotmeetingitsspecifiedrequirementsorthemanufacturernotbeingabletocarryoutanynecessarycorrectiveaction.
(b)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.GuidanceisavailablefromtheCenterforDevicesandRadiologicalHealth,DivisionofSmallManufacturers,InternationalandConsumerAssistance(HFZ-220),1350PiccardDr.,Rockville,MD20850,U.S.A.,telephone1-800-638-2041or240-276-3150,FAX240-276-3151.
(2)FDAmayinitiateandgrantavariancefromanydevicequalitysystemrequirementwhentheagencydeterminesthatsuchvarianceisinthebestinterestofthepublichealth.Suchvariancewillremainineffectonlysolongasthereremainsapublichealthneedforthedeviceandthedevicewouldnotlikelybemadesufficientlyavailablewithoutthevariance.
Sec.820.1范围
(a)适用性。
(1)本质量体系法规阐明了当前优良制造过程Currentgoodmanufacturingpractice(CGMP)的要求。
本标准适用于所有应用于人类的最终产品的设计、制造、包装、标识、贮存、安装和服务,所适用的管理方法、设备和控制。
本标准的目的是保证最终产品的安全性和有效性,并符合联邦食品、药品和化妆品法案FederalFood,DragandCosmeticAct(theact)。
本法规适用于所有的医疗器械最终产品制造商。
如果制造商仅从事本部分中的某些过程而未从事其它过程,则只需符合其实施的过程的要求。
对于Ⅰ类设备,设计控制仅适用于Sec.820.30(a)
(2)中列出的设备。
本法规不适用于最终产品的部件或零件制造商,但鼓励这类制造商把本法规的适当规定作为指南来使用。
人血和血器官制造商不受本部分法规的限制,但应遵循本章606部分法规的要求。
(2)本部分的规定适用于本部分定义的应用于人体的所有最终产品设备,不论其在美国本土制造还是进口的产品。
(3)在本法规中“适用时”(whereappropriate)出现过多次。
当要求根据“whereappropriate”被认为是合格时,其要求应被认为是“适用的”(appropriate),除非组织能提供文件证明其理由。
如果不执行导致产品不符合其特定的要求,或组织未执行必要的纠正措施,那么要求就是适用的(appropriate)。
(b)限制。
除非特别规定,则本部分质量体系法规是本章其它部分法规的补充要求。
在不能符合所有适用的法规,包括本章此部分和其它部分的情况,特别是对讨论中的设备,此法规应取代其它通用要求。
(c)权限。
PART820是在(21U.S.C.法令351、352、360、360c、360d、360e、360h、360i、360j、360l、370、374、381、383中)501、502、510、513、514、515、518、519、520、522、701、704、801、803下建立并发布的。
不符合本部分(Part820)的任何适用的规定,依据法令section501(h)条款,可判定该产品为假货或次品。
这类产品及对此不符合负责的任何个人,将依法被起诉。
(d)外国制造商。
如果把器械进口到美国的制造商拒绝FDA为确定器械是否符合本法规(Part820)所进行的检查,可采用section801(a)条款对其提出诉讼。
即准备出口到美国的设备,其设计、生产、包装、标签、贮存或服务中使用的方法和设备控制不符合本法令section520(f)和本部分(Part820)的要求,可按本法令section501(h)条款判定在此条件下制造的产品为劣质产品。
(e)豁免或特别许可。
(1)希望得到质量体系要求的豁免或特别许可,应符合法令section520(f)
(2)的要求。
根据本章Sec.10.30即FDA行政程序,来提交豁免或特别许可的申请。
可以从器械和辐射健康中心和小型制造商援助处获得指导,地址(HFZ-220),1350PiccardDr.,Rockville,MD20850,U.S.A.,电话1-800-638-2041或1-301-443-6597,传真301-443-8818。
(2)在有关部门确定特别许可符合美国公众健康的最大利益后,FDA可能发出设备质量体系的特别许可。
公在美国公众健康确实需要该设备,且如无此特别许可,则设备就不能得到使用的情况下,特别许可才有效。
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.Thefinisheddesignoutputisthebasisforthedevicem
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 21CFR 820 质量体系法规English Chinese 21 CFR 质量体系 法规 English
![提示](https://static.bdocx.com/images/bang_tan.gif)