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Subpart A--General Provisions A分部-通則 Sec. 820.1 Scope.范圍 (a)Applicability. (1) 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)(2). 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. 適用性. 本質(zhì)量體系規(guī)范提出了CGMP的要求。本（規(guī)范）要求管理所有醫(yī)療器械產(chǎn)品在設(shè)計，制造，包裝，標簽，貯存，安裝和服務中使用的方法，以及為此所使用的設(shè)施和控制（措施/方法）。本（規(guī)范）要求意在確保器械成品安全有效，并遵守聯(lián)邦食品，藥品，化妝品法案（本法案）。本規(guī)范確定/提出了適用于醫(yī)療器械成品制造商的基本要求。假如某制造商（的活動）僅涉及從屬于本規(guī)范規(guī)定的部分要求，并不涉及其他的要求，那么僅需要遵守適用于其操作所涉及部分的要求。關(guān)于I類醫(yī)療，設(shè)計控制僅適用于那些列于820.30（a）（2）（項下）的器械。本法規(guī)不適用于成品組件或部件制造商，但鼓勵其使用本法規(guī)的適當?shù)臈l款作為指導。人類血液和血液制品不受此規(guī)范管轄，而是從屬于本法案606部分。制造人類細胞、組織，和以人類細胞、組織為基礎(chǔ)的產(chǎn)品（HCT/Ps），定義于本法案1271.3（d）（部分），是指醫(yī)療器械[從屬于上市前評審或通知，或豁免，在本法案器械條款下，或（本法案）351（部分）（公共健康服務）生物產(chǎn)品許可證申報下遞交的申請。]從屬于此部分（820），也從屬于本法案1271C donor-eligibility程序，同時適用于本法案1271D現(xiàn)行的良好組織實踐。如果發(fā)生應用本法案1271部分和其他部分相沖突時，特別地適用于器械的規(guī)范代替更通用的（要求）。 (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. 本規(guī)范的條款/規(guī)定應適用于本規(guī)范定義的任何器械成品。即供人類使用，在美國的任何州或領(lǐng)土，哥倫比亞特區(qū)，或美屬波多黎哥聯(lián)邦，制造，進口或為進口提供的（器械成品）。 (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 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. 在本規(guī)范中數(shù)次使用術(shù)語“適當?shù)那闆r下/地方”。當一個要求被冠以“適當?shù)牡胤?情況下”，其被認為是“適當?shù)摹?。除非制造商能證明其理由得當除外。假如不執(zhí)行“適當?shù)摹币?，將可以有理由預期其會導致產(chǎn)品不能達到規(guī)定要求或制造商不能采取任何糾正措施。 (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. 此規(guī)范的質(zhì)量系統(tǒng)法規(guī)補充法案本章其他部分的法規(guī)，有明確地規(guī)定的地方除外。如果發(fā)生應使用本規(guī)范和本法案其他部分相沖突時，正在被討論的明確地適用于器械的要求將取代任何其他通用要求。 (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. 權(quán)威性/法律來源.在……的授權(quán)下建立和發(fā)行本規(guī)范（820）。根據(jù)法規(guī)501（h），不能遵守本規(guī)范的任何應用條款致使（出現(xiàn)）的劣質(zhì)器械，此器械及其負責人會遭受法律制裁。 (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. 外國制造商。假如某制造商提供進口給美國的器械，但拒絕允許或同意FDA為了完成以確定其符合本規(guī)范對其國外設(shè)施的檢查，將會出現(xiàn)本法案801（a）部分的后果——用此設(shè)施生產(chǎn)出的任何（提供進口給美國的）器械，其設(shè)計，制造，包裝，標簽，貯存，安裝，或服務使用的方法，設(shè)施和控制是不符合520（f）和本規(guī)范的要求。按照501（h）屬于劣質(zhì)產(chǎn)品。 (e)Exemptions or variances . (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 FDA's administrative procedures. Guidance is available from the Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance. 豁免后更改。任何希望請求豁免或更改器械質(zhì)量體系的請求，都要遵守本法案520（f）（2）的要求?；砻饣蜃兏鼞凑毡疽?guī)范10.30提出的程序遞交請求，即FDA管理程序?？蓮腇DA，CDRH，DSM，ICA等處獲得指南。 (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 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. （2）當FDA確定使用某種來自任何器械質(zhì)量體系要求的更改是最有益于公眾健康時，可能發(fā)起和同意更改。此更改僅只有公眾健康需，并且在不采取更改情況下器械不能被制造的十分可取時有效。 Sec. 820.3 Definitions.定義 (a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et 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. （a）法案是指聯(lián)邦食品，藥品和化妝品法修正案(secs. 201-903, 52 Stat. 1040 et seq., 修訂的(21 U.S.C. 321-394))。所有在法案201部分的定義均適用于本規(guī)范。 (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. （b）投訴是指任何書面的，電子的或口頭的交流聲稱在放行分發(fā)后某一器械相關(guān)的鑒定，質(zhì)量，耐久性，可靠性，安全，效力或性能不足（的一種活動）。 (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. 組件是指任何原料，物質(zhì)，小件，零件，軟件，固件，標簽，或被預期包括在一部分用于完成的，包裝的，貼標簽的器械的裝配（組件）內(nèi)的（物質(zhì)）。 (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. 控制號是指任何可區(qū)別的符號，如可區(qū)分的由數(shù)字或字母或二者組成的組合體。以此可確定制造，包裝，標簽，和發(fā)放的單個或一批器械的歷史。 (e)Design history file (DHF ) means a compilation of records which describes the design history of a finished device. 設(shè)計歷史文件（DHF）是指一份編輯的描述某器械成品設(shè)計歷史/來歷的記錄。 (f)Design input means the physical and performance requirements of a device that are used as a basis for device design. 設(shè)計輸入是指以某器械物理和性能要求為設(shè)計基礎(chǔ)的（活動）。 (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. 設(shè)計輸出指在每個設(shè)計階段的成果和最終總的設(shè)計成果。完成的設(shè)計輸出是以器械主記錄為基礎(chǔ)（來體現(xiàn)的），最終完成的設(shè)計輸出由器械，其包裝，標簽和主記錄組成。 (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. 設(shè)計評審是指文件的，全面的，系統(tǒng)的檢查某設(shè)計，評價（輸出）對于設(shè)計要求滿足的充分性，和設(shè)計滿足要求的能力和識別問題（所在）。 (i)Device history record (DHR ) means a compilation of records containing the production history of a finished device. 設(shè)計歷史記錄（DHR）是指編輯的包括某器械成品的歷史/來歷/制造的記錄。 (j)Device master record (DMR ) means a compilation of records containing the procedures and specifications for a finished device. 器械主記錄（DMR）是指編輯的包含某器械成品的程序和規(guī)范的記錄。 (k)Establish means define, document (in writing or electronically), and implement. 建立是指定義，文件化（書面或電子的），并執(zhí)行（的活動）。 (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. 器械成品指任何適于使用或可以運行的器械或器械附件，無論包裝，標識，滅菌與否。 (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. 批是指在本質(zhì)上相同條件下制造的，在規(guī)定的限度內(nèi)預期有統(tǒng)一的特性和質(zhì)量的一種或幾種組件或器械成品構(gòu)成的某單個類型，樣式，類別，型號，成分，或軟件版本。 (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. 最高管理層（為了同ISO9001統(tǒng)一）是指那些擁有權(quán)限去建立或改變器械制造商的質(zhì)量方針和質(zhì)量體系的高級雇員。 (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. 制造商是指任何設(shè)計，制造，構(gòu)造，組裝，或加工器械的人。制造商包括但不限于那些從事（合同）滅菌，安裝，再貼標，再加工，再包裝，或規(guī)范開發(fā)活動（的人）和從事這些（工作內(nèi)容）的國外實體的原始經(jīng)銷商。 (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. 制造物料是指任何用于生產(chǎn)或便于生產(chǎn)過程（運作）而使用的物料或物質(zhì)，或制造過程產(chǎn)生的（而不是制造商設(shè)計或預期的）以殘留物或雜質(zhì)（的形式）存在于器械成品內(nèi)或上的伴隨物或副產(chǎn)品。 (q)Nonconformity means the nonfulfillment of a specified requirement. 不合格是指未執(zhí)行/滿足規(guī)定的要求。 (r)Product means components, manufacturing materials, in- process devices, finished devices, and returned devices. 產(chǎn)品是指組件，生產(chǎn)/制造物料，過程中器械，器械成品和退回的器械。 (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. 質(zhì)量是指器械適于使用的整體特征和特性的能力，包括安全性和性能（方面）。 (t)Quality audit means a systematic, independent examination of a manufacturer's 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. 質(zhì)量審核是指系統(tǒng)的，獨立的考核制造商的質(zhì)量體系，即按照定義的時間間隔和在足夠的頻率下去確定質(zhì)量體系活動和其結(jié)果是否都符合質(zhì)量體系程序規(guī)定（的活動），因而（證明）程序被有效地執(zhí)行，并且質(zhì)量體系目標可達。 (u)Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. 質(zhì)量方針是指由最高管理層建立的組織關(guān)于質(zhì)量總的期望和方向。 (v)Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. 質(zhì)量體系是指執(zhí)行質(zhì)量管理（活動）的組織結(jié)構(gòu)，職責，程序，過程和資源。 (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 device's performance or safety specifications, or intended use. 再加工商是指任何加工，調(diào)節(jié)，革新，再包裝，修復/再貯存？，或做其他對器械成品性能，安全規(guī)范或預期用途大大地/顯著地變更（動作）的人。 (x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. 返工是指實施在不合格產(chǎn)品上，使其在放行發(fā)送前，能滿足規(guī)定的DMR要求的動作。 (y)Specification means any requirement with which a product, process, service, or other activity must conform. 規(guī)范是指一個產(chǎn)品，過程，服務或其他活動必須遵守的任何要求。 (z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. 確認是指用考核和提供客觀證據(jù)（的方式）來為特定的預期用途能始終如一地被滿足提供（證明）的活動。 (1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. 工藝驗證是指由一個過程產(chǎn)生的結(jié)果或產(chǎn)品能始終如一的滿足預先確定的規(guī)范要求建立的客觀證據(jù)。 (2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s). 設(shè)計確認是指用客觀證據(jù)建立器械規(guī)范同用戶需求和（產(chǎn)品）預期用途相一致（的證明活動）。 (aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. 驗證是指用考核和提供客觀證據(jù)證明規(guī)定要求已被滿足的活動。 Sec. 820.5 Quality system.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. 各制造商應建立并保持質(zhì)量體系。體系應適合于（制造商）特定的醫(yī)療器械的設(shè)計或制造，并滿足本部分要求。 Subpart B--Quality System Requirements 質(zhì)量體系要求 Sec. 820.20 Management responsibility.管理職責 (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. 質(zhì)量方針.最高管理層應建立組織的質(zhì)量方針和目標，并承諾（執(zhí)行）。最高管理層應確保質(zhì)量方針在組織內(nèi)各層面上得到理解，貫徹和保持。 (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. 組織.各制造商應建立并保持一個適當?shù)慕M織結(jié)構(gòu)，以確保器械的設(shè)計和生產(chǎn)符合本規(guī)范的要求。 (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. 職責和權(quán)限.各制造商應為（從事）影響質(zhì)量的管理，執(zhí)行和評估工作的人員建立適當?shù)穆氊?，?quán)限和相互關(guān)系，并保證（他們）執(zhí)行這些工作所必需的獨立性和權(quán)威性。 (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. 資源.各制造商應提供足夠的資源，包括安排經(jīng)培訓的人員（從事）管理，執(zhí)行，評價（包括內(nèi)審）（體系）滿足本規(guī)范要求的工作。 (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) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review. 管理者代表.最高管理層應以文件的形式任命/指定管理層中的一員（為管理者代表）。無論該成員在其他方面的職責如何，他應具有以下方面有權(quán)限和職責：確保質(zhì)量體系的要求按照此規(guī)范得到有效的建立并保持；向管理層報告質(zhì)量體系的表現(xiàn)供其評審。 (c)Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented. 管理評審.最高管理層應按照建立的程序，在規(guī)定的時間間隔和充分的頻率下評審質(zhì)量體系的適宜性和有效性。確保質(zhì)量體系滿足本規(guī)范和制造商建立的質(zhì)量方針和目標要求。評審時間和結(jié)果應記錄。 (d)Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met. 質(zhì)量策劃.各制造商應建立一個質(zhì)量計劃，規(guī)定/祥述與設(shè)計和制造器械有關(guān)的質(zhì)量實踐，資源和活動，并建立質(zhì)量要求將如何被滿足（的計劃）。 (e)Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate. 質(zhì)量體系程序.各制造商應建立質(zhì)量體系程序和指導書。適當情況下應在質(zhì)量體系中建立文件的結(jié)構(gòu)大綱。 Sec. 820.22 Quality audit.質(zhì)量審核 Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented. 各制造商應建立并保持質(zhì)量審核和操作審核的程序，保證質(zhì)量體系符合建立的質(zhì)量體系要求和確定體系的有效性。質(zhì)量審核應由對被審核的內(nèi)容沒有直接職責的人員執(zhí)行（即審核人員不能審核自己有直接職責的工作內(nèi)容）。在需要時應開展糾正措施，包括對缺陷的事物再審核。應編制每次質(zhì)量審核和發(fā)生的再審核的報告，此報告應由對被審核出問題負責的管理層復核。審核日期和結(jié)果及（發(fā)生的）再審核應記錄。 Sec. 820.25 Personnel.人員 (a)General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. 通則.各制造商應有足夠的人員，具備必要的教育，知識背景，培訓和經(jīng)驗，確保所有本規(guī)范要求的活動被正確的執(zhí)行。 (b)Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions. 培訓. 各制造商應建立識別必要的培訓的程序，確保所有人員接受培訓，勝任各自的（工作）職責。培訓應記錄。 作為培訓的一部分，應使員工意識到在工作中不當?shù)牟僮鲿е缕餍挡涣肌? 執(zhí)行驗證和確認活動的人員應意識到可能遭遇到的缺陷和錯誤是其工作（活動？）的一部分。 Subpart C--Design Controls 設(shè)計控制 Sec. 820.30 Design controls.設(shè)計控制 (a)General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. 總要求.任何III類、II類和列于表(a)(2)的I類器械的制造商應建立并保持控制器械設(shè)計的程序，確保特定的設(shè)計要求得到滿足。 (2) The following class I devices are subject to design controls: (i) Devices automated with computer software; and (ii) The devices listed in the following chart. Section Device 868.6810 Catheter, Tracheobronchial Suction. 878.4460 Glove, Surgeon's. 880.6760 Restraint, Protective. 892.5650 System, Applicator, Radionuclide,