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1、21 CFR 820Quality System Regulation质量体系手册Page # of 38Subpart A Gen eral Provisi onsA部分总则820.1 Scope.820.1范围820.3 Defi nitio ns.定义820.5 Quality system.质量体系Subpart B Quality System Requireme ntsB部分一一质量体系要求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
2、 Desig n Con trolsC部分一一设计控制820.30 Design controls.设计控制Subpart D Docume nt Con trolsD部分一一文件控制820.40 Docume nt con trols.文件控制Subpart E Purchasing ControlsE部分一一采购控制820.50 Purchas ing con trols.采购控制Subpart F Identification andF部分一一标识和可追溯性820.60 Ide ntificatio n.标识820.65 Traceability.可追溯性Subpart G Produc
3、tio n and Process Con trolsG部分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 validati on.过程确认Subpart H Accepta nee ActivitiesH部分一接收活动820.80 Receiving, in-process, and finished device accepta nee.接收设备准则，过程设备准则，最终设备准
4、 则820.86 Accepta nee status.接收状态Subpart I Nonconforming ProductI部分一一不合格产品820.90 Noncon formi ng product.不合格产品Subpart J Corrective and Preventive ActionJ部分一一纠正预防措施820.100 Corrective and preve ntive action.Traceability纠正预防措施SubpartKLabeli ngand Packaqi ngCon trolK部分标签与包装控制820.120 Device labeling.产品标识8
5、20.130 Device packagi ng.产品包装SubpartL Han dli ng.Storage,Distributi on. and In stallati onL部分一一操作、存储、分配以及安装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部分记录820.180 Ge neral requireme nts.总要求820.181 Device master record.产品控制记录820.184 Device
6、history 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Subpart N Servici ng820.200 Servici ng.Subpart O Statistical Tech ni ques820.250 Statistical tech ni ques.Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the Federal Food,
7、Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371,374, 381,383).Subpart A Gen eral Provisi ons4820.1 Scope4Subpart A Gen eral Provisi ons820.1 Scope.820.1范围(a) Applicability .适用性(1) Current good manufacturing practice (CGMP) requirements are set forth in
8、this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, in stallati on, and servici ng of all fini shed devices in ten ded for huma n use. The requireme nts in this part
9、 are inten ded to en sure that fini shed devices will be safe and effective and otherwise in complia nee 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 o
10、perations subject to the requirements in this part, and not 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 regulati o
11、n does not apply to manu facturers of comp onents or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidanee. Manufacturers of human blood and blood comp onents are not subject to this part, but are subject to part 606 of this cha
12、pter.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。本部分内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
13、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 part shall be applicable to any finished device as defined in this part, inten ded for huma n use, that is manu factured, imported, or offered for import inany State or Territory of the United States, the District of Columbia, o
14、r the Common wealth 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、 哥伦比亚地区和波多黎各共和国生产或进口到这些国家。(3) In this regulation the term wheappropriate is used several times. When arequirement is qualified by wheappropriate, is deemed to be appropriateuni ess the manu facturer can docume nt justificati
15、on otherwise. A requireme nt is appropriatef nonimpleme ntatio n could reas on ably be expected to result in the product not meeti ng its specified requireme nts or the manu facturer not being able to carry out any n ecessary 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，则可认为这一要求是适当的”(b) Limitations . The quality system regulation in this part supplements regulations in otherparts of this chapter exc
