FDA21CFRQSR820中英文对照版本.docx

1、FDA21CFRQSR820中英文对照版本21 CFR 820Quality System Regulation质量体系手册Subpart AGeneral ProvisionsA部分总则820.1 Scope.820.1围820.3 Definitions. 定义820.5 Quality system. 质量体系Subpart BQuality System RequirementsB部分质量体系要求820.20 Management responsibility. 管理者职责820.22 Quality audit. 质量审核820.25 Personnel. 职员Subpart CDe

2、sign ControlsC部分设计控制820.30 Design controls. 设计控制Subpart DDocument ControlsD部分文件控制820.40 Document controls. 文件控制Subpart EPurchasing ControlsE部分采购控制820.50 Purchasing controls. 采购控制Subpart FIdentification and TraceabilityF部分标识和可追溯性820.60 Identification. 标识820.65 Traceability. 可追溯性Subpart GProduction an

3、d Process ControlsG部分生产和过程控制820.70 Production and process controls. 产品和过程控制820.72Inspection,measuring, and test equipment. 检查、测量，测试仪器 820.75 Process validation. 过程确认Subpart HAcceptance ActivitiesH部分接收活动820.80 Receiving, in-process, and finished device acceptance.接收设备准则，过程设备准则，最终设备准则820.86 Acceptance

4、 status. 接收状态Subpart INonconforming ProductI部分不合格产品820.90 Nonconforming product. 不合格产品Subpart JCorrective and Preventive ActionJ部分纠正预防措施820.100 Corrective and preventive action. 纠正预防措施Subpart KLabeling and Packaging ControlK部分标签与包装控制820.120 Device labeling. 产品标识820.130 Device packaging. 产品包装Subpart

5、LHandling, Storage, Distribution, and Installation L部分操作、存储、分配以及安装820.140 Handling. 操作820.150 Storage. 存储820.160 Distribution. 分配820.170 Installation. 安装Subpart MRecordsM部分记录820.180 General requirements. 总要求820.181 Device master record. 产品控制记录820.184 Device history record. 产品历史记录820.186 Quality syst

6、em record. 质量体系记录820.198 Complaint files. 客户抱怨文件Subpart NServicing820.200 Servicing.Subpart OStatistical Techniques820.250 Statistical techniques.Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360

7、, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).Subpart AGeneral Provisions 4 820.1 Scope. 4Subpart AGeneral Provisions 820.1 Scope. 820.1围(a) Applicability. 适用性(1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requiremen

8、ts in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be

9、safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and no

10、t in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in 820.30(a) (2). This regulation does not apply to manufacturers of components or parts of

11、 finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components 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。本部分中的要求规定了在下列情况下使用的方法：所有的预期用于人类

12、的最终器械产品的设计、制造、包装、标记、储存、安装和服务中使用的方法。本部分的要求可确保最终器械的安全有效，并符合联邦食品、药品和化妆品法案。本部分容确定了适用于最终器械的制造商的基本要求。如果制造商从事的一些操作符合本部分的要求，而不是其他部分的要求，则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（a）（2）部分列出的那些器械。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部分的要求，但要遵守本章606的要求。(2) The provisions of this p

13、art shall be applicable to any finished device as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.本部分条款可适用于任何本部分规定的、预期用于人类的最终器械，这样的器械可在美国、哥

14、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 requirement is qualified by where appropriate, it is deemed to be appropriate unless the manufacturer can document justification otherwise. A requirement is appropriate if nonimplementation could re

15、asonably be expected to result in the product not meeting its specified requirements 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，则可认为这一要“适当的”。(b) Limitatio

16、ns. The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event that it is impossible to comply with all applicable regulations, both in this part and in other parts of this chapter, the regulations specific

17、ally applicable to the device in question shall supersede any other generally applicable requirements.局限性。除非明确声明有其他情况，否则本部分中质量体系法规是对本章其他部分的法规的补充。如果遵守所有适用法规（包括本部分的法规和本章其他部分的法规）是不可能的，则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. Part 820 is established and issued under authority of sections 501, 502, 510, 5

18、13, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as we

19、ll as any person responsible for the failure to comply, is subject to regulatory action.权威性。820部分容的是参照权威法案501，502，510，513，514，515，518，519，520，522，701，704，801，803（21U.S.C.351，352，360，360c,360d,360e,360h,360i,360j,360l,371,374,381,383 ）而制定和发布的。如果器械没有符合本部分的任何适用条款会，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

20、任。(d) Foreign manufacturers. If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpose of determining compliance with this part, it shall appear for purpo

21、ses of section 801(a) of the act, that the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the re

22、quirements of section 520(f) of the act and this part and that the devices manufactured at that facility are adulterated under section 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接受FDA对其国外设施的检查，以确定是否符合本部分801法案的容，则可认为生产该器械所使用的方法，设施、设备以及在该场地下生产的、将要进口到美国的器械的设计、生产、包装、标记、贮存、安装或服务不符合520（f）法案和本部分容的要求，并且按照501（h

23、）法案的规定，该场地下生产的器械为伪劣产品。(e) Exemptions or variances. 豁免或特殊许可：(1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according

24、 to the procedures set forth in 10.30 of this chapter, the FDAs administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance, (HFZ220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 18006382041 or 1301 443

25、6597, FAX 3014438818. （1）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。 可从器械与辐射健康中心，小型制造商服务部（HFZ-220）获得指南。(2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best intere

26、st 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健康的利益，FDA可鼓励并允许器械的质量体系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健康时才能保持其有效性，在没有特

27、殊许可的情况下不能大量的制造器械。1. 820.3 Definitions. 定义(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321394). All definitions in section 201 of the act shall 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部分中规定的所有定义都适用

28、于本部分的法规。(b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the 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、安全

29、性、有效性及性能等方面存在不足的行为。(c) Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly 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部分。(d) Control number means

30、 any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of 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

31、的历史。(e) Design history file (DHF) means a compilation of records which describes the design history of a finished device.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) Design input means the physical and performance requirements of a device that are used as a basis for device design.设计输入是指器械的物理要求和性能要求，其可作为器械

32、的设计基础。(g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, 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