醫(yī)療器材優(yōu)良制造的規(guī)范(共29頁)

1、醫(yī)療器材優(yōu)良制造規(guī)范目錄Content頁碼(Page)壹、總則、General 1一、法源依據(jù)1 Bylaw 1二、本規(guī)範之專用名詞2 Definitions 1貳、品質系統(tǒng)之要求、Quality System Regulation 2一、管理階層之責任1 Management Responsibility 2二、品質系統(tǒng)2 Quality System4三、合約審查3 Contract Review6四、設計管制4 Design Control7五、文件與資料管制5 Document and Data Control 9六、採購6 Purchasing 10七、客戶供應品之管制7 Contr

2、ol of Customer-supplied Product 12八、產品之識別與追溯性8 Product Identification and Traceability12九、製程管制9 Process Control 13十、檢驗與測試10 Inspection and Testing16十一、檢驗、量測及測試設備之管制11 Control of Inspection, Measurement and Test Equipment18十二、檢驗與測試狀況12 Inspection and Test Status 20十三、不合格品之管制13 Control of Nonconformin

3、g Product20十四、矯正與預防措施14 Corrective and Preventive Action 22十五、搬運、儲存、包裝、防護及 交貨15 Handling, Storage, Packaging, Preservation and Delivery24十六、品質紀錄之管制16 Control of Quality Records 25十七、內部品質稽核17 Internal Quality Audits26十八、訓練18 Training27十九、服務19 Servicing 27二十、統(tǒng)計技術20 Statistical Techniques 27參、附則 、Suppl

4、ement 27實施日期規(guī)定 Implementation Date27壹、總則、General一、本規(guī)範依藥事法第五十七條之規(guī)定訂定之。1 This practice has been established based on Article 57 of the Pharmaceutical Affairs Law.醫(yī)療器材製造工廠（以下簡稱製造業(yè)者）除應符合藥事法規(guī)定外，其品質制度應依本規(guī)範實施。Medical device manufacturers (shall be designated as manufacturers hereinafter) shall not only con

5、form to the Pharmaceutical Affairs Law, but their quality systems shall also follow this practice for the implementation.二、本規(guī)範之專用名詞其意義如下：2 Definitions(一)主動式醫(yī)療器材：指以電能或其他能源，非直接由人員或重力產生以發(fā)揮其功能者。2.1 active medical device: Any medical device relying for its functioning on a source of electrical energy or

6、any source of power other than that directly generated by the human body or gravity.(二)主動植入式醫(yī)療器材：指以醫(yī)療或外科方式，將主動式醫(yī)療器材的全部或部分植入人體或人體之自然腔道內，並持續(xù)留置者。2.2 active implantable medical device: Any active medical device which is intended to be totally or partially introduced surgically or medically, into the hum

7、an body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.(三)植入式醫(yī)療器材：指醫(yī)療器材以外科方式，全部或部分植入人體或人體之自然腔道內、替代上表皮或眼表面，並保留在人體內三十天以上，且只能藉由醫(yī)療或外科方式取出者。2.3 implantable medical device: Any medical device intendedto be totally or partially introduced into the hum

8、an body or natural orifice, or to replace an epithelial surface or the surface of the eyeby surgical intervention, and which is intended to remain after the procedure for at least 30 days and which can only be removed by medical or surgical intervention.(四)無菌醫(yī)療器材：指醫(yī)療器材經過滅菌處理，確認滅菌成效，並標示無菌字樣者。2.4 ster

9、ile medical device: Any medical device labelled as sterile.(五)客戶怨訴：指客戶以書面、電訊或口頭的方式，對上市醫(yī)療器材之特性、品質、耐用性、可靠性、安全性及功能等表示不滿。2.5 customer complaint: Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a m

10、edical device that has been placed on the market.(六)說明事項：指製造業(yè)者為執(zhí)行矯正或預防措施及符合中央衛(wèi)生主管機關管理規(guī)定，於交貨時，對醫(yī)療器材之使用、修改、退貨及銷毀，提供補充的資料或建議事項。2.6 advisory notice: Notice issued by the manufacturer, subsequent to delivery of the medical device, to provide supplementary information and/or to advise what action should b

11、e taken inthe use of a medical device,the modification of a medical device,the return to the manufacturer of a medical device,the destruction of a medical device,for the purpose of corrective or preventive action and in compliance with national regulatory requirements.(七)風險分析：界定危害及評估風險之有效的調查資訊。2.7 r

12、isk analysis: The investigation of available information to identify hazards and to estimate risks.貳、品質系統(tǒng)之要求、Quality System Regulation 一、管理階層之責任1 Management Responsibility(一)品質政策1.1 Quality Policy製造業(yè)者管理階層擔負實責者，應明文訂定其品質政策，包括品質目標與對品質的承諾。品質政策應與製造業(yè)者組織目標和其顧客之期望及需求相關聯(lián)。製造業(yè)者應確保此品質政策於組織內各階層均瞭解、實施與維持。The manu

13、facturers management with executive responsibility shall define and document its policy for quality, including objectives for quality and its commitment to quality. The quality policy shall be relevant to the manufacturers organisational goals and the expectations and needs of its customers. The man

14、ufacturer shall ensure that this policy is understood, implemented and maintained at all levels of the organisation.(二)組織1.2 Organisation1.權責 Responsibility and Authority對能影響品質之管理、執(zhí)行及查證工作人員，其職責、權限與相互關係均應加以明文規(guī)定。特別是對於那些需要組織賦予其自由與授權，以進行下列工作的人員：The responsibility, authority and interrelation of personne

15、l who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organisational freedom to:(1) 發(fā)起措施以防止有關於產品、製程及品質系統(tǒng)有任何不符合情事之發(fā)生；(1) initiate action to prevent the occurrence of any nonconformities relating to the product, process and qua

16、lity system;(2) 鑑別並記錄任何有關於產品、製程及品質系統(tǒng)的問題；(2) identify and record any problems relating to the product, process and quality system;(3) 經由規(guī)定管道發(fā)起、建議或提出解決辦法；(3) initiate, recommend or provide solutions through designated channels;(4) 查證解決措施之執(zhí)行情況；(4) verify the implementation of solutions;(5) 在缺陷或不滿意狀況被矯正

17、前，管制不合格產品被進一步加工、交貨或安裝。(5) control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.2.資源 Resources製造業(yè)者應鑑定資源需求，並提供適當?shù)馁Y源，包括指派訓練有素人員以從事管理、執(zhí)行及查證活動，包括內部品質稽核。The manufacturer shall identify resource requirements and pr

18、ovide adequate resources, including the assignment of trained personnel for management, performance of work and verification activities including internal quality audits.3.品質負責人 Quality Representative製造業(yè)者管理階層擔負實責者，應指派管理階層中之一員為品質負責人，於原有職責外，應授權從事下列工作：The manufacturers management with executive respons

19、ibility shall appoint a member of the manufacturers own management who, irrespective of other responsibilities, shall define authority for:(1) 確保品質系統(tǒng)係按照本規(guī)範予以建立、實施及維持。(1) ensuring that a quality system is established, implemented and maintained in accordance with this GMP and(2) 將品質系統(tǒng)之運作情況向管理階層提出報告，以

20、供檢討，並作為改進品質系統(tǒng)的依據(jù)。(2) reporting on the performance of the quality system to the management for review and as a basis for improvement of the quality system.(3) 確保其所產製醫(yī)療器材之安全及功效。(3) ensuring the safety and effectiveness relating to the manufacturing medical device(s).(三)管理審查1.3 Management Review製造業(yè)者管理階

21、層擔負實責者，應於規(guī)定期間內對品質系統(tǒng)加以審查，以充分確保滿足本規(guī)範之要求以及供應者所宣示的品質政策與目標，能繼續(xù)地適合且具有效果。審查之紀錄應予維持。The manufacturers management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this Practic

22、e and the manufacturers stated quality policy and objectives. Records of such reviews shall be maintained.二、品質系統(tǒng)2 Quality System(一)概述2.1 General製造業(yè)者應建立、書面訂定及維持其品質系統(tǒng)，藉以確保產品符合規(guī)定的要求，製造業(yè)者應準備品質手冊涵蓋本規(guī)範之各項要求。此項品質手冊應包括或提及品質系統(tǒng)的各項書面程序，以及略述本品質系統(tǒng)所使用之文件架構。The manufacturer shall establish, document and maintain a

23、 quality system as a means of ensuring that product conforms to specified requirements. The manufacturer shall prepare a quality manual covering the requirements of this Practice. The quality manual shall include or make reference to the quality system procedures and outline the structure of the doc

24、umentation used in the quality system. The manufacturer shall establish and document the specified requirements.(二)品質系統(tǒng)程序2.2 Quality System Procedures製造業(yè)者應：The supplier shall1.遵照本規(guī)範要求及既定之品質政策，明定各項書面程序；及(1) prepare documented procedures consistent with the requirements of this Practice and the manufa

25、cturers stated quality policy; and2.有效執(zhí)行品質系統(tǒng)與其書面程序。(2) effectively implement the quality system and its documented procedures.為達到本規(guī)範之目的，構成品質系統(tǒng)之各項程序，其範圍與細節(jié)應視工作之複雜性、所使用之方法與技巧、以及執(zhí)行業(yè)務人員所需之訓練而定。For the purposes of this GMP, the range and detail of the procedures that form part of the quality system shall

26、 be dependent upon the complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity.(三)品質規(guī)劃2.3 Quality Planning製造業(yè)者應明文訂定如何達成品質要求。品質規(guī)劃應與製造業(yè)者品質系統(tǒng)中之其他要求相一致，且應以適合製造業(yè)者作業(yè)方式之格式予以書面化。為達成產品、專案計畫，或合約所規(guī)定之要求，製造業(yè)者應適時考慮下列適合之項目The supplier shall de

27、fine and document how the requirements for quality shall be met. Quality planning shall be consistent with all other requirements of a suppliers quality system and shall be documented in a format to suit the suppliers operation. The supplier shall give consideration to the following activities, as a

28、ppropriate, in meeting specified requirements for products, project or contracts:1.擬訂品質計畫；(1) the preparation of quality plans;2.為達到要求的品質，可能需要之任何管制、製程、設備（包括檢驗與測試設備）、夾具、所有生產資源與技術之鑑別及獲得；(2) the identification and acquisition of any controls, processes, equipment, (including inspection and test equipme

29、nt), fixtures, resources and skills that may be needed to achieve the required quality;3.確保設計、製程、安裝、服務、檢驗及測試程序，以及適用文件之間具有相容性；(3) ensuring the compatibility of the design, the production processes, installation, servicing, inspection and test procedures and the applicable documentation;4.需要時，得更新品質管制、

30、檢驗及測試技術，包括發(fā)展新儀器等；(4) the updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation;5.鑑別任何超出已知現(xiàn)有技術狀況能力之量測要求，而開發(fā)此項所需能力，須有充裕的時間；(5) the identification of any measurement requirement involving capability that exceeds the known state o

31、f the art, in sufficient time for the needed capability to be developed;6.在產品獲得實現(xiàn)的適當階段，適切的查證工作之鑑別；(6) the identification of suitable verification at appropriate stages in the realisation of product;7.釐清所有特性項目與需求的允收準則，包含主觀因素在內；(7) the clarification of standards of acceptability for all features and r

32、equirements, including those which contain a subjective element;8.品質紀錄之鑑別與準備。(8) the identification an preparation of quality records.製造業(yè)應建立並維持完整的製造程序、安裝與維修之檔案，且以書面文字規(guī)範醫(yī)療器材之每一類型或型號的產品規(guī)格與品質制度要求（製程與品質保證），或此類資訊之參照處所。The manufacturer shall establish and maintain a file containing documents defining the

33、product specifications and quality system requirements (process and quality assurance) forcomplete manufacturing, andinstallation and servicing, if appropriate,for each type/model of medical device, or referring to the location(s) of this information.三、合約審查3 Contract Review(一)概述3.1 General製造業(yè)者應建立並維持

34、合約審查及協(xié)調各項審查活動之書面程序。The manufacturer shall establish and maintain documented procedures for contract review and for the co-ordination of these activities.(二)審查3.2 Review在提出每一份標單，或接受每一份合約或訂單（記載要求條件）之前，製造業(yè)者應對該標單、合約或訂單加以審查，以確保：Before submission of a tender, or the acceptance of a contract or order (stat

35、ement of requirement), the tender, contract or order shall be reviewed by the manufacturer to ensure that:1.要求事項已適切地明文規(guī)定。如係口頭訂貨，沒有書面的要求依據(jù)時，製造業(yè)者應確保在接受之前，訂單之要求事項均已獲同意；(1) the requirements are adequately defined and documented; where no written statement of requirement is available for an order receive

36、d by verbal means, the manufacturer shall ensure that the order requirements are agreed before their acceptance;2.在合約或訂單中，任何事項與標單所載不同之處，皆已解決；(2) any differences between the contract or order requirements and those in the tender are resolved;3.製造業(yè)者有能力滿足合約或所接訂單之要求事項。(3) the manufacturer has the capabi

37、lity to meet the contract or order requirements.(三)合約修訂3.3 Amendment to a Contract製造業(yè)者應鑑別合約如何修訂，並正確地傳送至製造業(yè)者組織內之有關部門。The manufacturer shall identify how an amendment to a contract is made and correctly transferred to the functions concerned within the manufacturer organisation.(四)紀錄3.4 Records合約審查紀錄應

38、予以維持。Records of contract reviews shall be maintained.四、設計管制4 Design Control(一)概述4.1 General製造業(yè)者應建立並維持各項書面程序，藉以管制與查證產品之設計，以確保規(guī)定要求得以達成。The manufacturer shall establish and maintain documented procedures to control and verify the design of the product in order to ensure that the specified requirements

39、are met.設計過程中，製造業(yè)者應評估風險分析之必要性，並維持任何風險分析的執(zhí)行紀錄。Throughout the design process, the manufacturer shall evaluate the need for risk analysis and maintain records of any risk analysis performed.(二)設計與開發(fā)規(guī)劃4.2 Design and Development Planning製造業(yè)者應為每一設計與開發(fā)活動擬訂各項計畫，這些計畫應描述或言及這些活動，並界定彼等執(zhí)行之責任。指派合格人員並配備充分資源擔任設計與開發(fā)

40、工作。這些計畫應隨設計的進展而予以更新。The manufacturer shall prepare plans for each design and development activity. The plans shall describe or reference these activities and define responsibility for their implementation. The design and development activities shall be assigned to qualified personnel equipped with a

41、dequate resources. The plans shall be updated as the design evolves.(三)組織與技術之介面4.3 Organisational and Technical Interfaces參與設計過程的各群組間，其組織與技術之介面，應予以界定，必要的資料須予文件化、傳遞並定期檢討。Organisational and technical interfaces between different groups which input into the design process shall be defined and the neces

42、sary information documented, transmitted and regularly reviewed.(四)設計輸入4.4 Design Input與產品相關之設計輸入要求，包括適用的法令、規(guī)章要求，製造業(yè)者應予鑑別並文件化，且應審查輸入要求之選擇是否適當。不完整、混淆不清或互相抵觸的要求，應與提出這些要求者會同加以解決。Design input requirements relating to the product, including applicable statutory and regulatory requirements shall be identi

43、fied, documented and their selection reviewed by the manufacturer for adequacy. Incomplete, ambiguous or conflicting requirements shall be resolved with those responsible for imposing these requirements.設計輸入應將任何合約檢討的結果均納入考慮。Design input shall take into consideration the results of any contract revie

44、w activities.(五)設計輸出4.5 Design Output設計輸出應予文件化，並以對設計輸入要求能被查證及作有效性確認方式予以表達。Design output shall be documented and expressed in terms that can be verified and validated against design input requirements.設計輸出應：Design output shall:1.符合設計輸入要求；(1) meet the design input requirements;2.包含或列出參考之允收準則；(2) conta

45、in or make reference to acceptance criteria;3.鑑別對產品安全與正常作用極為重要的設計特性（如操作、儲存、搬運、維護及處理之要求）；(3) identify those characteristics of the design that are crucial to the safe and proper functioning of the product (e.g. operating, storage, handling, maintenance and disposal requirements).設計輸出文件在發(fā)佈前，應加以審查。Desi

46、gn output documents shall be reviewed before release.(六)設計審查4.6 Design Review在設計過程中之適當階段，應規(guī)劃並執(zhí)行對設計結果作正式書面審查。每次設計審查參與者應包括所有有關所審查之設計階段部門之代表，需要時，並請其他專業(yè)人員參加。各項審查紀錄應予維持。At appropriate stages of design, formal documented reviews of the design shall be planned and conducted. Participants at each design rev

47、iew shall include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required. Records of such reviews shall be maintained.(七)設計查證4.7 Design Verification在設計過程中之適當階段，應實施設計查證，以確保設計階段之輸出能符合其設計輸入要求。設計查證措施應予記錄。At appropriate stages o

48、f design, design verification shall be performed to ensure that the design stage output meets the design stage input requirements. The design verification measures shall be recorded.(八)設計確認4.8 Design Validation為確保產品符合既定之使用者需求或要求項目，應實施設計確認。Design validation shall be performed to ensure that product c

49、onfirms to defined user needs and/or requirements.製造業(yè)者應執(zhí)行臨床評估，並維持紀錄，以作為設計確認的一部份。As part of design validation, the supplier shall perform and maintain records of clinical evaluations.(九)設計變更4.9 Design Changes所有設計變更與修改事宜，在實施前應予以鑑別、記載、審查並經被授權人員核準。All design changes and modifications shall be identified

50、, documented, reviewed and approved by authorised personnel before their implementation.五、文件與資料管制5 Document and Data Control(一)概述5.1 General製造業(yè)者應建立並維持書面程序，以管制所有與本規(guī)範要求有關之文件與資料，在可行之範圍內尚包括外來之原始文件，如標準與顧客之圖樣等。The manufacturer shall establish and maintain documented procedures to control all documents and

51、 data that relate to the requirements of this Practice including, to the extent applicable, documents of external origin such as standards and customer drawings.(二)文件與資料之核發(fā)5.2 Document and Data Approval and Issue文件與資料在發(fā)行前，應由被授權人員對其適切性加以審查和批準。為防止誤用過時或失效的文件，用以識別文件最新修訂狀況之文件總覽表或相當?shù)奈募苤瞥绦?，應予建立且易供人查閱。The

52、documents and data shall be reviewed and approved for adequacy by authorised personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents shall be established and be readily available to preclude the use of invalid and/or obsol

53、ete documents.此項管制應確保：This control shall ensure that:1.對品質系統(tǒng)有效運作之重要作業(yè)場所，均有適當文件的有效版本可供使用；(1) the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed;2.失效或過時文件應迅速自發(fā)行單位或使用場所移走，否則就應設法保證不致被誤用；

54、(2) invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use.3.為法律或知識保存目的而保留的任何過時文件，應予以適當標明。(3) any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified.製造業(yè)者對於過時的管制文件應至少保存一份副本，並

55、確定其保存期限，此期限應確保其產製之醫(yī)療器材在規(guī)定的有效期限內，能提供產品的製造規(guī)格。The manufacturer shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that specifications to which medical devices have been manufactured are available for at least the lifetime of

56、the medical device as defined by the manufacturer.(三)文件與資料變更5.3 Document and Data Changes除非另有特別指定，文件之變更應由其執(zhí)行原始審查及核準之同一功能單位或組織審查與核準。若指定其他功能單位或組織審查時，該單位或組織應獲得原審查所依據(jù)的背景資料，據(jù)以審核。Changes to documents and data shall be reviewed and approved by the same functions/ organisations that performed the original r

57、eview and approval unless specifically designated otherwise. The designated functions/ organisations shall have access to pertinent background information upon which to base their review and approval.如實際可行時，應於文件或其適當之附件中標明變更的性質。Where practicable, the nature of the change shall be identified in the do

58、cument or the appropriate attachments.六、採購6 Purchasing(一)概述6.1 General製造業(yè)者應建立並維持書面程序，以確保所購產品符合規(guī)定要求。The manufacturer shall establish and maintain documented procedures to ensure that purchased product conform to specified requirements.(二)分包商之評估6.2 Evaluation of Sub-contractors製造業(yè)者應：The supplier shall

59、:1.根據(jù)分包商達成分包合約要求之能力，包括品質系統(tǒng)與任何特定之品質保證要求，來評估及選擇分包商；(1) evaluate and select subcontractors on the basis of their ability to meet sub-contract requirements including the quality system and any specific quality assurance requirements;2.界定製造業(yè)者對分包商之管制方式與程度，此項界定應視產品類別、分包產品對最終產品品質之影響；以及如適用時，分包商品質稽核報告，或過去展現(xiàn)能力

60、與績效之品質紀錄而定；(2) define the type and extent of control exercised by the supplier over subcontractors. This shall be dependent upon the type of product, the impact of subcontracted product on the quality of final product and, where applicable, on the quality audit reports and/or quality records of the