美國(guó)FDA-醫(yī)療器械體系法規(guī)QSR820中英文版

美國(guó)FDA 醫(yī)療器械體系法規(guī)QSR820中文版Part 820質(zhì)量體系法規(guī)目錄Subpart A- 總則 820.1 范圍 820.3 定義 820.5 質(zhì)量體系Subpart B 質(zhì)量體系要求 820.20 管理職責(zé) 820.22 質(zhì)量審核 820.25 人員Subpart C- 設(shè)計(jì)控制 820.30 設(shè)計(jì)控制Subpart D- 文件控制 820.40 文件控制Subpart E- 采購(gòu)控制 820.50 采購(gòu)控制Subpart F- 標(biāo)識(shí)與可追溯性 820.60 標(biāo)識(shí) 820.65 可追溯性Subpart G - 生產(chǎn)和過(guò)程控制 820.70 生產(chǎn)和過(guò)程控制 820.72 檢驗(yàn)、測(cè)量和試驗(yàn)設(shè)備 820.75 過(guò)程確認(rèn)Subpart H - 驗(yàn)收活動(dòng): 820.80 進(jìn)貨、過(guò)程和成品器械檢驗(yàn) 820.86 檢驗(yàn)狀態(tài)Subpart I 不合格品 820.90 不合格品Subpart J - 糾正和預(yù)防措施 820.100 糾正和預(yù)防措施Subpart K 標(biāo)識(shí)和包裝控制 820.120 設(shè)備標(biāo)簽 820.130 設(shè)備包裝Subpart L 搬運(yùn)/儲(chǔ)存/分銷和安裝820.140 搬運(yùn) 820.150 貯存 820.160 分銷 820.170 安裝Subpart L 記錄 820.180 記錄的通用要求 820.181 設(shè)備主要記錄 820.184 設(shè)備歷史記錄 820.186 質(zhì)量體系記錄 820.198 投訴文件Subpart M 服務(wù) 820.200 服務(wù)Subpart N 統(tǒng)計(jì)技術(shù) 820.250 統(tǒng)計(jì)技術(shù)Subpart A總則Subpart A-General ProvisionsSec.820.1 范圍Sec. 820.1 Scope.（a） 適用性Applicability。（1） 本質(zhì)量體系法規(guī)闡明了當(dāng)前良好制造法規(guī)Current good manufacturing practice（CGMP）的要求。本標(biāo)準(zhǔn)適用于所有預(yù)期用于人類的成品器械的設(shè)計(jì)、制造、包裝、標(biāo)識(shí)、儲(chǔ)存、安裝和服務(wù)中所使用的管理方法、設(shè)施和控制。本標(biāo)準(zhǔn)的目的是保證成品器械的安全性和有效性，并符合聯(lián)邦食品、藥品和化妝品法案Federal Food, Drag and Cosmetic Act （the act）。本法規(guī)適用于所有的醫(yī)療器械成品制造商。如果制造商僅從事本部分有要求服從的某些過(guò)程而未從事其它過(guò)程，則只需符合其實(shí)施的過(guò)程的要求。對(duì)于類設(shè)備，設(shè)計(jì)控制僅適用于Sec.820.30（a）（2）中列出的設(shè)備。本法規(guī)不適用于成品器械的部件或零件制造商，但鼓勵(lì)這類制造商把本法規(guī)的適當(dāng)規(guī)定作為指南來(lái)使用。人血和血液成分制造商不受本部分法規(guī)的限制，但應(yīng)遵循本章606部分法規(guī)的要求。Current good manufacturing practice (CGMP) requirements are set forth in 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, 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 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 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) This regulation does not apply to manufacturers of components or parts of 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. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271. .3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.（2） 本部分的規(guī)定適用于本部分定義的預(yù)期用于人體的所有成品器械，不論其在美國(guó)(包含:美國(guó)任何州或領(lǐng)土,哥倫比亞特區(qū),波多黎各聯(lián)邦)本土制造還是進(jìn)口,提供進(jìn)口的產(chǎn)品。(2) The provisions of this part 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.（3） 在本法規(guī)中“適用時(shí)”（where appropriate）出現(xiàn)過(guò)多次。當(dāng)要求根據(jù)“where appropriate”被認(rèn)為是合格時(shí)，其要求應(yīng)被認(rèn)為是“適用的”（appropriate），除非組織能提供文件證明其理由。如果不執(zhí)行預(yù)期結(jié)果會(huì)導(dǎo)致產(chǎn)品不符合其特定的要求，或組織不需要執(zhí)行任何必要的糾正措施，那么要求就是適用的（appropriate）。(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 non-implementation could reasonably 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.（b） 限制。除非特別規(guī)定，則本部分質(zhì)量體系法規(guī)是本章其它部分法規(guī)的補(bǔ)充要求。在不能符合所有適用的法規(guī)，包括本章此部分和其它部分的情況，特別是對(duì)討論中的設(shè)備，此法規(guī)應(yīng)取代其它通用要求。(b) The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.（c） 權(quán)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下建立并發(fā)布的。不符合本部分（Part 820）的任何適用的規(guī)定，依據(jù)法令section 501（h）條款，可判定該產(chǎn)品為偽劣產(chǎn)品。這類產(chǎn)品及對(duì)此不符合負(fù)責(zé)的任何個(gè)人，將依法被起訴。(c)Authority. Part 820 is established and issued under authority of sections 501, 502, 510, 513, 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 well as any person responsible for the failure to comply, is subject to regulatory action.（d） 外國(guó)制造商。如果把器械進(jìn)口到美國(guó)的制造商拒絕允許或同意FDA對(duì)其外國(guó)工廠履行為確定器械是否符合本法規(guī)（Part 820）所進(jìn)行的檢查，可按section 801（a）條款對(duì)其提出訴訟。即準(zhǔn)備出口到美國(guó)的設(shè)備，其設(shè)計(jì)、生產(chǎn)、包裝、標(biāo)簽、貯存或服務(wù)中使用的方法和設(shè)備控制不符合本法令section 520（f）和本部分（Part 820）的要求，可按本法令section 501（h）條款判定在此條件下制造的產(chǎn)品為偽劣產(chǎn)品。(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 purposes 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 requirements 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.（e） 豁免或特別許可/ Exemptions or variances（1） 任何人希望得到任何醫(yī)療器械質(zhì)量體系要求的豁免或特別許可，應(yīng)符合法令section 520（f）（2）的要求。根據(jù)本章Sec.10.30即FDA行政程序，來(lái)提交豁免或特別許可的申請(qǐng)?？梢詮钠餍岛洼椛浣】抵行暮托⌒椭圃焐淘帿@得指導(dǎo)，地址（HFZ-220），1350 Piccard Dr.，Rockville，MD20850，U.S.A.，電話1-800-638-2041或1-301-443-6597，傳真301-443-8818。(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 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, International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.（2） 在有關(guān)部門(mén)確定此種改變符合美國(guó)公眾健康的最佳利益時(shí)，F(xiàn)DA可能發(fā)起并同意器械質(zhì)量體系的特別許可。公在美國(guó)公眾健康確實(shí)需要該設(shè)備，且如無(wú)此特別許可，則器械就不可能充分有效的生產(chǎn)的情況下，特別許可才有效。(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 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.（f） 本部分不適用于本章897部分定義的煙草銷售商。Sec.820.3 定義 / Definitions（a） 法案Act。指明Federal Food, Drug and Cosmetic Act，如修正的（secs.201-903，52 Stat. 1040 et sep.，21 U.S.C. 321-394）。所有法案section 201中的定義在本部分法規(guī)中均適用。(a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040et seq., as amended (21 U.S.C. 321-394). All definitions in section 201 of the act shall apply to the regulations in this part.（b） 投訴Complaint。在設(shè)備交付后所有的書(shū)面的、電子的或口頭的，對(duì)設(shè)備的標(biāo)識(shí)、質(zhì)量、耐用性、可靠性、安全性、有效性和性能方面缺陷的信息。(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.（c） 部件Component。所有意圖用來(lái)包含成為已完成的、包裝、標(biāo)識(shí)的器械的一部分的原材料、物資、構(gòu)件、零件、軟件、固件、連接件、標(biāo)簽或它們的集合。(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.（d） 控制號(hào)Control number。任何鑒別性符號(hào)，如由字母、數(shù)字或它們的組合形成的唯一性組合，由控制號(hào)可以確定一批或一個(gè)器械的制造、包裝、標(biāo)識(shí)和交付的歷史。(d)Control number means 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.（e） 設(shè)計(jì)歷史文件Design history file（DHF）。成品器械的設(shè)計(jì)歷史記錄的匯總。(e)Design history file (DHF ) means a compilation of records which describes the design history of a finished device.（f） 設(shè)計(jì)輸入Design input。器械實(shí)體和性能要求，是產(chǎn)品設(shè)計(jì)的基礎(chǔ)。(f)Design input means the physical and performance requirements of a device that are used as a basis for device design.（g） 設(shè)計(jì)輸出Design output。是指每個(gè)設(shè)計(jì)階段和最后所有的設(shè)計(jì)成果的結(jié)果。已完成的設(shè)計(jì)輸出是器械主記錄的基礎(chǔ)。全部最終完成的設(shè)計(jì)輸出，由器械及其包裝和標(biāo)識(shí)和設(shè)備主記錄組成。(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.（h） 設(shè)計(jì)評(píng)審Design review。是指對(duì)設(shè)計(jì)的一個(gè)文件化的、全面的、系統(tǒng)的檢查，評(píng)價(jià)其滿足設(shè)計(jì)要求，評(píng)價(jià)其有能力滿足要求，并識(shí)別任何問(wèn)題。(h)Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.（i） 設(shè)備歷史記錄Device history record（DHR）。成品器械歷史記錄的匯總。(i)Device history record (DHR ) means a compilation of records containing the production history of a finished device.（j） Device master record（DMR）。成品器械的程序和規(guī)范的匯總。(j)Device master record (DMR ) means a compilation of records containing the procedures and specifications for a finished device.（k） 建立Establish。定義文件（書(shū)面或電子的）并執(zhí)行。(k)Establish means define, document (in writing or electronically), and implement.（l） 成品器械Finished device。設(shè)備或其附件，無(wú)論其是否包裝、標(biāo)識(shí)或滅菌，能夠滿足使用要求或者說(shuō)能夠?qū)崿F(xiàn)其功能。(l)Finished 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, or sterilized.（m） Lot或batch。一個(gè)或多個(gè)元件或成品器械，均為同一種規(guī)格、型號(hào)、尺寸、成分或軟件版本，在相同條件下生產(chǎn)，滿足相同的特性和質(zhì)量要求。(m)Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.（n） 執(zhí)行職責(zé)的管理者M(jìn)anagement with executive responsibility。是組織的高級(jí)員工，他們負(fù)有建立或更改組織的質(zhì)量方針和質(zhì)量體系的職權(quán)。(n)Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturers quality policy and quality system.（o） 制造商/組織Manufacturer。是指設(shè)計(jì)、制造、制作（fabricate）、裝配或加工成品器械的任何人。制造商包括但不僅限于根據(jù)合同執(zhí)行滅菌、安裝、重新標(biāo)識(shí)、重新制造、重新包裝或特定的開(kāi)發(fā)職責(zé)的制造商，和執(zhí)行這些職責(zé)的國(guó)外組織的國(guó)內(nèi)分銷商。(o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.（p） Manufacturing material。指任何用于或用于催化制造過(guò)程的任何原料或物質(zhì)，在制造過(guò)程中產(chǎn)生的伴隨的成分或副產(chǎn)品，其在成品器械中/上呈現(xiàn)為殘留物或雜質(zhì)，它不是制造商的設(shè)計(jì)或意圖。(p)Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.（q） 不合格Nonconformity。未滿足規(guī)定的要求。(q)Nonconformity means the nonfulfillment of a specified requirement.（r） 產(chǎn)品Product。部件、原材料、在制品、成品和返回品。(r)Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.（s） 質(zhì)量Quality。一組固有特性滿足要求的程序，包括安全和性能。(s)Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.（t） 質(zhì)量審核Quality Audit。按規(guī)定的時(shí)間間隙和頻率，對(duì)制造商的質(zhì)量體系進(jìn)行系統(tǒng)、客觀的檢查，以確定質(zhì)量體系活動(dòng)及其結(jié)果符合質(zhì)量體系程序，這些程序得到有效執(zhí)行，程序適應(yīng)質(zhì)量目標(biāo)的需求。(t)Quality audit means a systematic, independent examination of a manufacturers quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.（u） 質(zhì)量方針Quality policy。由制造商的最高管理者發(fā)布的組織總的質(zhì)量宗旨和方向。(u)Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.（v） 質(zhì)量體系Quality system。質(zhì)量管理的組織結(jié)構(gòu)、職責(zé)、程序、過(guò)程和資源。(v)Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.（w） Remanufacturer。指對(duì)成品器械進(jìn)行處理、修整、修復(fù)、重新包裝、恢復(fù)或其它活動(dòng)的人，使成品器械的性能、安全規(guī)范或預(yù)期用途產(chǎn)生重大更改。(w)Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished devices performance or safety specifications, or intended use.（x） 返工Rework。為使不合格品在其交付前符合DMR的要求而采取的措施。(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.（y） 規(guī)范Specification。產(chǎn)品、過(guò)程、服務(wù)或其它活動(dòng)應(yīng)符合的要求。(y)Specification means any requirement with which a product, process, service, or other activity must conform.（z） 確認(rèn)Validation。通過(guò)檢查和提供客觀證據(jù)證明滿足預(yù)期用途的要求。(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.（1） 過(guò)程確認(rèn)Process validation。根據(jù)客觀證據(jù)確定過(guò)程可持續(xù)產(chǎn)生滿足預(yù)先確定規(guī)范的結(jié)果或產(chǎn)品。(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.（2） 設(shè)計(jì)確認(rèn)Design validation。根據(jù)客觀證據(jù)確定設(shè)備規(guī)范符合使用者的需求和預(yù)期用途。(2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).（aa） 驗(yàn)證Verification。通過(guò)檢查和提供客觀證據(jù)證明滿足規(guī)定的要求。(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.Sec.820.5 質(zhì)量體系/ Quality system.制造商應(yīng)建立并實(shí)施適應(yīng)特定的醫(yī)療器械設(shè)計(jì)或制造，并符合本部分要求的質(zhì)量體系。Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.Subpart B質(zhì)量體系要求/ Quality System RequirementsSec.820.20 管理職責(zé)/ Management responsibility（a） 質(zhì)量方針：負(fù)有執(zhí)行職責(zé)的管理者應(yīng)建立質(zhì)量方針和目標(biāo)以及在質(zhì)量方面的承諾，應(yīng)保證組織內(nèi)所有級(jí)別都能正確理解并執(zhí)行質(zhì)量方針。(a)Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.（b） 組織：建立并保持適宜的組織結(jié)構(gòu)，確保產(chǎn)品的設(shè)計(jì)和生產(chǎn)符合本部分（Part 820）的要求。(b)Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.（1） 職責(zé)和權(quán)限。制造商應(yīng)明確影響質(zhì)量的管理、操作和評(píng)價(jià)人員的職責(zé)、權(quán)限及相互關(guān)系，為其提供執(zhí)行這些工作必需的自主權(quán)和權(quán)限。(1)Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.（2） 資源。制造商應(yīng)提供適當(dāng)?shù)馁Y源，包括由經(jīng)過(guò)培訓(xùn)的人員，執(zhí)行管理、操作和包括內(nèi)部質(zhì)量審核在內(nèi)的活動(dòng)，以符合本部分（Part 820）的要求。2)Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.（3） 管理者代表。最高管理者應(yīng)在管理層中以書(shū)面方式指定一名管理者代表，無(wú)論其在其它方面的職責(zé)如何，應(yīng)具有以下方面的職責(zé)和權(quán)限：(3)Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:（i） 確保根據(jù)本部分（Part 820）的要求有效地建立、實(shí)施和保持質(zhì)量管理體系；(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and（ii） 向負(fù)有執(zhí)行職責(zé)的管理者報(bào)告質(zhì)量體系運(yùn)行情況，以供評(píng)審。(ii) Reporting on the performance of the quality system to management with executive responsibility for review.（c） 管理評(píng)審。負(fù)有執(zhí)行職責(zé)的管理者，應(yīng)按程序規(guī)定的時(shí)間間隔對(duì)質(zhì)量體系進(jìn)行審核。確保質(zhì)量體系的持續(xù)適宜性和有效性，以滿足本標(biāo)準(zhǔn)的要求和組織規(guī)定的質(zhì)量方針和目標(biāo)。評(píng)審的日期和結(jié)果應(yīng)形成文件