FDA-21-CFR-QSR820-中英文对照版本

1、21 CFR § 820Quality System Regulati on质量体系手册Subpart A Gen eral Provisi onsA局部一一总那么820.1 Scope.820.1 围820.3 Defi nitio ns.定义820.5 Quality system.质量体系Subpart B Quality System Requireme ntsB 局部质量体系要求820.20 Man ageme nt resp on sibility.管理者职责820.22 Quality audit.质量审核820.25 Perso nn el.职员Subpart C D

2、esi gn Con trolsC 局部一一设计控制820.30 Design controls.设计控制Subpart D Docume nt Con trolsD 局部一一文件控制820.40 Docume nt con trols.文件控制Subpart E Purchas ing Con trolsE 局部一一采购控制820.50 Purchasing controls.采购控制Subpart F Ide ntificati on andTraceabilityF局部一一标识和可追溯性820.60 Identification.标识820.65 Traceability.可追溯性Sub

3、partG Producti onand ProcessCon trolsG局部一一生产和过程控制820.70 Producti on and process con trols.产品和过程控制820.72 In spect ion, measuri ng,and testequipme nt.检查、测量，测试仪器820.75 Process validatio n.过程确认Subpart H Accepta nee ActivitiesH局部一接收活动820.80Recei ving,in-process,andfini shed device accepta nee.接收设备准那么，过程设

4、备准那么，最终设备准那么820.86 Accepta nee status.接收状态Subpart I Nonconforming ProductI局部一一不合格产品820.90 Noncon formi ng product.不合格产品Subpart JCorrective and Preve ntiveActio nJ局部纠正预防措施820.100 Corrective and preve ntive actio n.纠正预防措施SubpartK Labeli ngandPackagi ngCon trolK局部标签与包装控制820.120 Device labeli ng.产品标识820

5、.130 Device packagi ng.产品包装SubpartL Han dli ng,Storage,Distributi on, and InstallationL局部一一操作、存储、分配以与安装820.140 Handlin g.操作820.150 Storage.存储820.160 Distributio n.分配820.170 In stallatio n.安装Subpart M RecordsM局部记录820.180 Ge neral requireme nts.总要求820.181 Device master record.产品控制记录820.184 Device hist

6、ory record.产品历史记录820.186 Quality system record.质量体系记录820.198 Complaint files.客户抱怨文件820.250 Statistical techniques.Subpart N Servici ng820.200 Servici ng.Subpart O Statistical Tech niq ues360c,360d,360e,360h,360i,360j,360l, 371, 374, 381,383).Subpart A Gen eral Provisi ons3§ 820.1 Scope. 3Subpar

7、t A Gen eral Provisi ons§ 820.1 Scope.820.1 围(a) Applicability适用性(1) Curre nt good manu facturi ng practice (CGMP) requireme nts are set forthin this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controlsused for, the design,manu fac

8、ture, packag in g, labeli ng, storage, in stallati on, and servic ing of all finisheddevices intended for human use. The requirements in this part areintendedto ensure thatfinished devices will be safe and effectiveandotherwise in complianee with the Federal Food, Drug, and Cosmetic Act (the act). T

9、his part establishes basic requireme nts applicable to manu facturers of finishedmedical devices. If a manufacturer engages in only some operationssubjectto the requireme nts in this part, and not in others,thatmanufacturerneed only comply with those requirementsapplicable to theoperati onsin which

10、it isengaged. WithrespecttoclassI devices,desig ncon trolsapply only tothose deviceslistedin§820.30(a)(2).Thisregulatio n does not apply to manu facturers of comp onents or parts of fini shed devices, but such manu facturers are en couraged to use appropriate provisi ons of this regulation as g

11、uidanee.Manufacturersof human blood and bloodcomponents are not subject to this part, but are subject to part 606 of this chapter.在本质量体系法规QSR中阐述了 CGMP的要求。本局部中的要求规定了在以下情况下使用的方法：所有的预期用于人类的最终器械产品的设计、制造、包装、标记、储存、 安装和效劳中使用的方法。本局部的要求可确保最终器械的平安有效，并符合联邦食 品、药品和化装品法案。本局部容确定了适用于最终器械的制造商的根本要求。如果制 造商从事的一些操作符合本局部

12、的要求，而不是其他局部的要求，那么该制造商只需符 合那些用于这些操作上的要求。对于I类医疗器械，设计控制仅适用于820.3 a2局部列出的那些器械。本法规不适用于最终器械的组件和部件的制造商，但鼓励这 样的制造商使用本法规中的适宜条款做指南。生产人体血液和血液组件的制造商可不遵 守本局部的要求，但要遵守本章 606的要求。(2) The provisionsof this part shall be applicableto any finished device asdefined in this part, intended for human use, that is manufactu

13、red, imported,or offered for import in any State or Territoryof the United States, theDistrict of Columbia, or the Common wealth of Puerto Rico.本局部条款可适用于任何本局部规定的、预期用于人类的最终器械，这样的器械可在美国、 哥伦比亚地区和波多黎各国生产或进口到这些国家。(3) In this regulation the term where appropriate ' ' is used several times.When a r

14、equirement is qualified by where appropriate, ' ' it is deemed tobe appropriate ' ' uni ess the manu facturer can docume nt justificati on otherwise. A requirementis appropriate ' ' if nonimplementationcouldreas on ably be expected to resultin the product not meeti ng its spe

15、cifiedrequirements or the manufacturer not being able to carry out any necessary corrective action.本法规中使用几次词语“适当处。当一个要求被“适当处修饰时，这一要求就被认 为是“适当的，除非制造商能以文件的形式提出其它的正当理由。如果不实施某个要 求就会导致产品不满足其规定的要求或制造商不能开展必要的纠正措施，那么可认为这 一要“适当的。(b) Limitati ons . The quality system regulati on in this partsuppleme ntsregula

16、tionsin other parts of this chapter except where explicitly statedotherwise. In the eve nt that it is impossible to comply with all applicable regulati ons,both in this part and in other parts of this chapter, theregulations specifically applicable to the device in questionshall supersede anyother g

17、en erally applicable requireme nts.局限性。除非明确声明有其他情况，否那么本局部中质量体系法规是对本章其他局部的法规的补充。如果遵守所有适用法规包括本局部的法规和本章其他局部的法规是不可能的， 那么指定应用于讨论中器械的法规应代替其他通用的要求。(c) Authority 360c, 360d, 360e, 360h, 360i, 360j, 3601, 371,374, 381,383). Thefailure to comply with any applicableprovisionin this part renders a deviceadulter

18、ated un der secti on 501(h) of the act. Such a device, as well as any pers on resp on sible for the failure to comply, is subject to regulatory actio n.360c,360d,360e,360h,360i,360j,360l,371,374,381,383丨而制定和发布的。如果器械没有符合本局部的任何适用条款会，按照501法案，可认为该种器械为伪劣产品，造成器械不符合 性的人员都要负一定责任。(d) Foreig n manu facturers.

19、If a manu facturer who offers devices for import intothe United States refuses to permit or allow the completion of a Food and DrugAdministration (FDA) inspection of the foreign facility for the purpose of determ ining complia nee with this part, it shall appear for purposes of sect ion 801(a) of th

20、e act, that the methods used in, and the facilities and con trols usedfor, the desig n, manu facture, packag ing, labeli ng, storage, in stallatio n,orservicingof any devices produced at such facility that are offered for importinto the Un ited States do not conform to the requireme nts of sect ion

21、520(f) ofthe act and this part and that the devices manufactured at that facility are adulterated un der secti on 501(h) of the act.国外制造商：如果将器械进口到美国的制造商拒绝承受FDA寸其国外设施的检查，以确定是否符合本局部801法案的容，那么可认为生产该器械所使用的方法，设施、设备以与在该场地下 生产的、将要进口到美国的器械的设计、生产、包装、标记、贮存、安装或效劳不符合520f法案和本局部容的要求，并且按照501 h法案的规定，该场地下生产的器械为伪劣产 品

22、。(e) Exemptio ns or varia nces豁免或特殊许可：(1)Any pers on who wishes to petiti on for an exempti on or varia nee fromany device quality system requireme nt is subject to the requireme nts of secti on520(f)(2) of the act. Petiti ons for an exempti on or varia neeshall be submittedaccording to the procedur

23、es set forth in §10.30 of this chapter, the FDA sadmi nistrative procedures1任何申请对器械质量体系要求豁免或特殊许可的人员都要遵守法案520(f)(2)的要求。按照本章10.30中阐述的程序要求FDA的管理程序，将豁免或特殊许可的申请提交给FDA 可从器械与辐射安康中心，小型制造商效劳部HFZ-220获得指南。(2) FDA may initiate and grant a variance from any device qualitysystemrequirement when the agency de

24、termines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.当代理商确定这样的特殊许可是为了公众安康的利益，FD/可鼓励并允许器械的质量体系

25、要求有一些特殊许可。 而且这样的许可只有在保持器械一直有利于公众的安康时才能保 持其有效性，在没有特殊许可的情况下不能大量的制造器械。1. § 820.3 Definitions.定义(a) Actshall apply to the regulations in this part.法案是指联邦食品、药品和化装品法案。法案中201局部中规定的所有定义都适用于本局部的法规。(b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the

26、 identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.抱怨：抱怨是指任何以书面、口头、电讯的形式宣称，已放行销售的医疗器械在其特性、 质量、耐用性、可靠性、平安性、有效性与性能等方面存在缺乏的行为。(c) Componentmeans any raw material, substance, piece, part, software, firmware, labeling, or a

27、ssembly which is intended to be included as part of the finished, packaged, and labeled device.组件：组件是指任何原材料、物质、零件、部件、软件、固件软件硬件相结合、标记或 装配件，可作为最终器械、包装器械和标记器械的一局部。(d) Control number means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history o

28、f the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.控制是指任何有特色的符号，如：字母或数字的有特色的组合，或者两者的结合，从中可以 确定最终产品批或单元的生产、包装、标记和销售的历史。(e) Design history file (DHF) means a compilation of records which describes the design history of a finished d

29、evice.设计历史文件DHF是指记录的汇编，描述了一个最终器械的设计历史。f)Desig n in put means the physical and performa nee requireme nts of a device thatare used as a basis for device desig n.设计输入是指器械的物理要求和性能要求，其可作为器械的设计根底。(g) Desig n output means the results of a desig n effort at each desig n phase and at the end of the total de

30、sig n effort. The fini shed desig n output is the basis for the device master record. The total finished design output consists of the device, its packag ing and labeli ng, and the device master record.设计输出是指每一设计阶段和总体设计的设计努力的结果。最终器械的设计输出是由器 械、器械的包装、标签和器械主记录构成。the(h) Desig n review means a docume nte

31、d, comprehe nsive, systematic exam in ati on of a design to evaluate the adequacy of the design requirements, to evaluatecapability of the design to meet these requirements, and to identify problems.设计评审是指对设计的形成文件的、全面的、系统的检查以便评价设计要求的充分性，设of records containingthe计满足要求的能力以与识别问题。(i) Device history reco

32、rd (DHR) means a compilation product ion history of a fini shed device.设备历史记录DHR是指包含最终器械生产历史的记录汇编(j)Device master record (DMR) means a compilation procedures and specificati ons for a fini shed device.器械主记录DMR是指包含最终器械的程序和规的记录汇编。(k)Establish means define,document (in writingimpleme nt.建立是指规定、形成文件手写的、

33、电子的和实施。of records containingorelectro ni cally),theandorareto(l) Fini shed device means any device or accessory to any device that is suitable for use or capable of functioning,whether or not it is packaged, labeled,sterilized.最终器械是指任何适于使用或能够运行的器械或器械的附件，无论其是否经包装、标记或灭 菌。(m)Lot or batchmeans one or mo

34、re components or finished devices that consist ofa singletype, model, class, size,composition,or software version thatmanufactured under essentiallythe same conditionsand that are intendedhave un iform characteristics and quality within specified limits.批是指最终器械、一个或多个组件，其可由唯一的型号、规格、类型、尺寸、结构或软件版 本构成，这

35、些器械和组件是在一样的条件下生产的，在规定的围有一样的特性和质量。(n)Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer ' s quality policy and quality system.有行政职责的管理者是指有权确定质量方针和质量体系或对质量方针和质量体系作出更改的 制造商的高级雇员。any pers onw

36、ho desig ns,manu factures,fabricates,a finished device.Manufacturerincludes but is notperform thefun cti onsof con tractsterilizatio n,rema nu facturi ng, repack ing, orspecificati ondistributors of foreig nen titiesperform ingthese(o)Manu facturermeansthose whorelabeli ng, and in itialassembles, or

37、 processes limited to in stallati on, developme nt, fun cti ons.制造商是指任何对最终器械进展设计、生产、制作、组装或加工的人。制造商包括但并不仅 仅只限于是那些完成灭菌、安装、重新标记、重新制造、重新包装、制定规的人，或者完成 上述操作的境外初始销售商(p)Manufacturing material means any material or substanee used in or used to facilitate the manu facturi ng process, a con comita nt con stitu

38、e nt, or a byproductcon stitue nt produced duri ng the manu facturi ng process, which is prese nt in or onthe finished device as a residue or impurity not by design or intent of the manu facturer.制造材料是指任何使用的材料或物质，这些材料的使用可便于生产加工，或在生产过程中产 生的伴随物或副产物，这些物质的是作为残留物或杂质存在于最终器械上，它的产生不是设 计出来的，也不是制造商想要的。(q)Nonc

39、onformity means the nonfulfillment of a specified requirement. 不合格是指不满足规定要求(r)Product means components, manufacturingmaterials, in- process devices,fini shed devices, and retur ned devices.产品是指组件、制造材料、过程中的器械、最终器械和返回器械。(s)Quality means the totality of features and characteristics that bear on theabil

40、ity of a device to satisfy fit ness-for- use,in clud ingsafety andperforma nee.质量是指器械满足良好使用性能的总体的特性和性能，包括平安和性能。(t)Quality audit means a systematic,in depe ndent exam in ati on of amanufacturer ' s quality system that i s performed at defined intervals and at sufficie nt freque ncy to determ ine

41、whether both quality system activities and theresults of such activities comply with quality system procedures, that these procedures are impleme nted effectively, and that these procedures are suitable to achieve quality system objectives.质量审核是指按照规定的时间间隔对制造商的质量体系进展的系统的、独立的检查，以确定 质量体系活动和活动的结果符合质量体系程

42、序，并确保质量体系程序得到有效的实施并适合 于实现质量体系的目标。(u)Quality policy means the overall inten ti ons and direct ion of an orga ni zati onwith respectto quality, as established by management withexecutiveresp on sibility.质量方针是指与组织质量有关的总的意图和方向，质量方针是由最高管理层制定的。(v) Quality system means theorganizationalstructure,responsibi

43、lities,procedures, processes, and resources for impleme nti ng quality man ageme nt.质量体系是指完成组织的质量管理所需的组织结构、职责、程序、过程和资源。(w)Remanufacturer means any person who processes, conditions,renovates,repackages, restores, or does any other act to a fini shed device that significantlychanges the finisheddevice

44、 ' s performanee or safetyspecificati ons, or inten ded use.二手制造商是指加工、改造、翻修、再次包装、修复或对最终器械采取其他措施来对器械的 性能或平安规或预期用途做重要更改的人。(x) Rework means actio n take n on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.返工是指对不合格产品采取的措施以便使其在放行和

45、销售前满足规定的器械主记录的要求。(y)Specificatio nmeans any requireme nt with which a product, process, service,or other activity must conform.规是指产品、过程、效劳或其他活动必须满足的任何要求。(z)Validatio nmeans con firmati onby exam in ati onand provisi onof objectiveevidenee that the particularrequirementsfor a specificintended use can

46、 becon siste ntly fulfilled.确认是指通过检查和提供客观证据确认能够持续的满足指定用途的特殊要求。 Process validation means establishing by objectiveevidenee that a processcon siste ntlyproduces a result or product meeti ng itspredeterm inedspeeifieati ons.过程确认是指通过客观证据确定过程能持续生产出满足其预先确定的规要求。(2) Designvalidationmeans establishingby obje

47、ctive evidenee that devicespecificati ons conform with user n eeds and inten ded use(s).设计确认是指通过客观证据来确定器械规符合用户需求和预期使用用途。(aa) Verificati on means con firmati onby exam in ati on and provisi on of objectiveevidence that specified requirements have been fulfilled.验证是指通过检查和提供客观证据以确认规定的要否得到满足。1. § 8

48、20.5 Quality systems质量体系Each manufacturershall establish and maintaina quality system that isappropriate for the specific medical device(s) desig ned or manu factured, and that meets the requireme nts of this part.每一个制造商应建立和保持一个适用于指定医疗器械设计和生产的质量体系并满足本局部的 要求。Subpart B Quality System Requireme ntsB局部：

49、质量体系要求§ 820.20 Management responsibility(a) Quality policy管理职责policy: Management with executive responsibilityshall establish itsand objectives for, and commitment to, quality.Management withexecutive responsibilityshall ensure that the quality policy is understood,implemented, and maintained a

50、t all levels of the organization.质量方针：最高管理者应制定企业的质量方针和目标和对质量的承诺。最高管理者应确保 质量方针在组织各层次得到理解、实施和保持。(b) Organization:Each manufacturershall establish and maintain an adequateorga ni zati onal structure to en sure that devices are desig ned and produced in accorda nce with the requireme nts of this part.组织

51、：每一个制造商应建立和保持适宜的组织结构以确保器械的设计和生产按照本局部的 要求进展。 Responsibilityand authority:Eachmanufacturershall establish theappropriate responsibility, authority, and interrelation of all personnel whoman age, perform, and assess work affect ingquality, and provide thein depe ndence and authority n ecessary to perfo

52、rm these tasks.职责和权限：每一个制造商应确定人员的职责、权限和相互关系，这些人员负责管理、执 行和评价对质量有影响的工作。(2) Resources: Each manufacturershall provide adequate resources, including theassignment of trained personnel, for management, performanee of work, and assessment activities,including internal quality audits, to meet therequireme

53、nts of this part.资源：每一个制造商应提供充足的资源以满足本局部的要求，包括指定培训管理人员，操 作人员的人员，以与评价活动包括部审核。(3) Management representative:Management with executiveresponsibilityshallappoint,and document such appointmentof, a member of management who,irrespective of other responsibilities,shall have established authority overand re

54、sp on sibility for:管理者代表：最高管理者应任命一名管理者并记录这样的任命，不管在其他方面的职责如 何，他应该具有以下方面的职责和权限：(i) Ensuring that quality system requirements are effectivelyestablished and effectively maintained in accorda nee with this part; and确保质量管理体系要求能按照本局部的要求得到有效的建立和保持。(ii) Report ing on the performa nee of the quality system t

55、o man ageme nt with executive resp on sibility for review.向最高管理者汇报质量体系的业绩。(c) Management review: Management with executive responsibilityshall review thesuitability and effective ness of the quality system at defi ned in tervals and with sufficie nt freque ncy accord ing to established procedures to

56、 en sure that the quality system satisfies therequireme ntsof this part and themanufacturer'sestablished quality policy and objectives. The results ofquality system reviews shall be documented.管理评审：最高管理者按照规定的时间间隔和按照规定程序所确立的有效频率评价质 量管理体系的适宜性和有效性，以确保质量体系满足本局部的要求和制造商的质量方针 和目标。质量体系评审的日期和结果应形成文件。(d)

57、Qualityplanning:Each manufacturer shall establish a quality plan whichdefi nes the quality practices, resources and activities releva nt to devicesthat are designed and manufactured. The manufacturershall establish how therequireme nts for quality will be met.质量筹划：每一个制造商应建立一个质量方案以规定与所设计和生产的器械有关的质 量规，资源和活动。制造商应确定质量要如何得到满足的。(e) Qualitysystem procedures: Each manufacturershall establish quality systemprocedures and in str