EDQM實驗室聯(lián)合審計標(biāo)準(zhǔn)指南Word版

1、EDQM: PA/PH/OMCL (06) 72 (EDIV/04) 2006年7月Standard “Aide mmoire” for the Mutual Joint Audit of Official Medicines Control Laboratories藥品官方控制實驗室聯(lián)合審計標(biāo)準(zhǔn)指南I. General一、概況This “aide-mmoire” was elaborated on a standard checklist for EN ISO/IEC 17025 and corresponding EA and ILAC guidelines, published by a

2、n accreditation body on the internet. Specific OMCL requirements arising from adopted OMCL guidelines were incorporated.這個指南是為闡述檢測和校準(zhǔn)實驗室能力的通用要求和相應(yīng)的歐洲認(rèn)證協(xié)會及國際實驗室認(rèn)可合作組織準(zhǔn)則的一個標(biāo)準(zhǔn)清單，并被一個認(rèn)證機構(gòu)發(fā)表在互聯(lián)網(wǎng)上。藥品官方檢驗實驗室的具體要求因被采用的藥品官方檢驗實驗室準(zhǔn)則而注冊成立。This document has been revised and updated in accordance with the second

3、edition of the EN ISO/IEC 17025 of 15th May 2005.此文件已被修改和更新，符合了2005年5月15日第二版的檢測和校準(zhǔn)實驗室能力的通用要求。The questions in the first column are addressed to the testing laboratories; they are to be answered thoroughly by the laboratory itself before the evaluation takes place, with indication of corresponding re

4、ference documents (e.g. Quality Manual, SOP, working instructions etc.) to provide an efficient assessment basis to the auditors. Should any requirement of the standard be non-applicable, this must be indicated by NA under the References column and duly justified.第一列的問題是針對測試中的實驗室；要求實驗室在評估開始前，根據(jù)文件和相應(yīng)

5、的參考指標(biāo)全部解答，（例如：質(zhì)量手冊，標(biāo)準(zhǔn)操作規(guī)程，工作指示等），從而為核數(shù)師提供一個有效的評估依據(jù)。假如任何一個標(biāo)準(zhǔn)的要求不適用，則必須在參考項下注明“不適用”，并用合理的解釋說明。During the audit, this document provides a practical tool for the auditors to make sure that all elements of the ISO/IEC 17025 standard and OMCL guidelines are covered, but it will not be used as such to prep

6、are the audit report.在審計過程中，這份文件為審計人員提供了一個實用的工具，以確保所有的檢測和校準(zhǔn)實驗室能力的通用要求標(biāo)準(zhǔn)以及藥品官方檢驗實驗室準(zhǔn)則所涵蓋的內(nèi)容，但文件并不會使用像這樣準(zhǔn)備的審計報告。This document may also be used by OMCLs as self-assessment of the implementation status of the2 / 68 Management System, independently of any external assessment.檢測和校準(zhǔn)實驗室能力的通用要求也可使用這份文件，作為管理系

7、統(tǒng)執(zhí)行情況的自我評估，它獨立于任何的外部評估。II. Definitions and Abbreviations二、定義和縮略詞Documents, records: documents and records can be stored in paper or electronic (computer) form. Rules must be defined for the availability of, access to and safeguarding of electronic records.文件，記錄：文件和記錄可以以紙張或電子（電腦）的形式存儲。且必須為電子記錄的可用性、訪問

8、和維護定義相應(yīng)的規(guī)章制度。QM = quality manualQM =質(zhì)量手冊O(shè)MCL = Official Medicines Control LaboratoryOMCL =藥品官方檢驗實驗室MJA = Mutual Joint AuditMJA =聯(lián)合審計OOS = Out of SpecificationOOS =超標(biāo)NB: in the text Authority refers to: competent authority that gives the order to test a medicinal productNB：官方文件中指：主管機關(guān)下令檢測藥品EDQM/OMCL

9、NETWORK MJA AUDIT INFORMATION歐洲藥品管理委員會/藥品官方檢驗實驗室網(wǎng)絡(luò)聯(lián)合審計信息(to be filled in prior to the MJA or during assessment as an audit record)（提前填寫，并在聯(lián)合審計或評估期間作為審計記錄）Name of OMCL 藥品官方檢驗實驗室名稱MJA Number 聯(lián)合審計號Self-assessment 自我評估 YES 是 NO 否Date of self-assessment or MJA 聯(lián)合審計或自我評估日期If YES date of submission 自我評估項填“

10、有”的，填提交日期Name of person responsible 負(fù)責(zé)人姓名Signature 簽名If NO date of MJA 自我評估項填“否”的，填聯(lián)合審計日期Name of MJA team coordinator 聯(lián)合審計團隊協(xié)調(diào)員姓名Name of MJA team members 聯(lián)合審計團隊成員姓名Name of person issuing this record 此記錄發(fā)行者姓名SUMMARY摘要 (figures in parentheses refer to standard EN ISO/IEC 17025)（括號中的數(shù)字參考檢測和校準(zhǔn)實驗室能力的通用要求

11、標(biāo)準(zhǔn)）1. Organisation 組織機構(gòu)1.1 Organisation and management 組織和管理機構(gòu)(4.1)2. Management system 管理系統(tǒng)2.1 Management system 管理系統(tǒng)(4.2)2.2 Document control 文件監(jiān)控(4.3)2.3 Record control 記錄監(jiān)控(4.13)3. External co-operation (with competent authorities and suppliers)對外合作（和主管部門及供應(yīng)商）3.1 Testing order review 順序?qū)彶闄z測(4.4)

12、3.2 Sub-contracting of tests 分包檢測(4.5)3.3 Purchasing services and supplies 采購服務(wù)和供應(yīng)(4.6)3.4 Service to the authority 服務(wù)管理機構(gòu) (4.7)3.5 Complaints 起訴(4.8)4. Maintenance of the management system管理系統(tǒng)的維護4.1 Control of nonconforming testing work 控制不合格檢測工作(4.9)4.2 Improvement 改善(4.10)4.3 Corrective action 糾正

13、措施(4.11)4.4 Preventive action 預(yù)防措施(4.12)4.5 Internal audits 內(nèi)部審計(4.14)4.6 Management reviews 管理審查(4.15)5. Personnel 人員(5.2)6. Premises and equipment 物業(yè)及設(shè)備6.1 Premises 物業(yè)(5.3)6.2 Equipment 設(shè)備(5.5)6.3 Computer system, control of data 計算機系統(tǒng)，數(shù)據(jù)控制(5.4)6.4 Measurement traceability 可追溯性測量(5.6)6.5 Reference

14、 standards 參考標(biāo)準(zhǔn)(5.6/OMCL)7. Handling of test items 檢測項目處理7.1 Sampling 取樣(5.7)7.2 Handling of test items 檢測項目處理(5.8)8. Test methods 檢測方法8.1 Test methods and procedures, including validation (5.4)檢測方法和程序，包括驗證8.2 Questions relevant for method transfer and screening 有關(guān)問題的方法轉(zhuǎn)讓和篩選(5.4/OMCL)8.3 Questions r

15、elevant for laboratory-developed methods (5.4)有關(guān)問題的實驗室開發(fā)方法8.4 Assuring the quality of test results (5.9/OMCL)保證檢測結(jié)果質(zhì)量8.5 Technical records (4.13.2)技術(shù)記錄9. Test reports 檢測報告9.1 Reporting the results 報告結(jié)果(5.10)9.2 Tests performed by subcontractors 由分包商進行測試(5.10.6)1. Organisation組織YNReferences/Comments參

16、考/評論1.1 Organisation and management (4.1)組織和管理1.1.1(4.1.1) - Name and address of the OMCL藥品官方檢驗實驗室的名稱和地址-Legal identity of the organisation (entry in the commerce register or public institution)該組織的合法身份（登記在商業(yè)注冊處或公共機構(gòu)）-Field of activities of the OMCL藥品官方檢驗實驗室現(xiàn)場活動o Market surveillance testing 市場監(jiān)督檢測o

17、Official Batch release testing官方批放行檢測o -Name and address of the laboratory實驗室的名稱和地址-Field of activities of the laboratory (general)實驗室現(xiàn)場活動（一般）Has the OMCL already been accredited?該藥品官方實驗室是否已經(jīng)被認(rèn)可？If YES, scope for which accreditation has been granted and by which accreditation body如果已被認(rèn)可，獲資格認(rèn)證的范圍，且被哪

18、個機構(gòu)認(rèn)證If NO, scope of the applied Management System如果未被認(rèn)可，這個應(yīng)用管理系統(tǒng)的范圍Scope of activities to be audited during the MJA聯(lián)合審計期間的活動審計范圍1.1.2(4.1.4) Is the laboratory part of a parent organisation? If YES what organisation?這個實驗室是否是上級組織的一部分？如果是，是什么組織1.1.3(4.1.5e) Is there one or several organisational chart

19、(s) for the whole OMCL showing the position of the testing laboratory, and is such a chart available for the testing laboratory itself?是否有一個或是數(shù)個組織結(jié)構(gòu)圖，為藥品官方實驗室顯示該檢測實驗室的位置，且這種圖標(biāo)是否能供實驗室本身使用？1.1.4(4.1.4) Are the responsibilities and authorities of the key personnel in the laboratory suitably defined so

20、that conflicts of interest can be avoided?是否界定了實驗室中關(guān)鍵人員的責(zé)任和權(quán)力，來避免利益沖突？1.1.5(4.1.5b )Is it possible to exclude any influence on the results exercised by persons or organisations external to the testing?是否可以排除由個人或機構(gòu)進行的外部檢測而對結(jié)果造成的任何影響？1.1.6Is it ensured that the OMCL is not engaged in other activities

21、that may endanger its impartiality, its independence and its integrity?是否能保證藥品官方檢驗實驗室沒有從事其他可能危及其公正性，獨立性和完整性的活動？1.1.7(4.1.5b) Is the technical and financial independence between the laboratory and external customers ensured?在實驗室和外部客戶之間是否能確保技術(shù)和經(jīng)濟的獨立？1.1.8(藥品官方 How is it ensured that the OMCL performs

22、the檢驗實驗室) testing of products independently from any contract work by order of a pharmaceutical manufacturer or entrepreneur?如何確保藥品官方檢驗實驗室對來自任何藥品生產(chǎn)商或企業(yè)家的合同要求進行獨立的產(chǎn)品測試？See contracts with other customers, see if the OMCL controls products from the contractor看看其他客戶的合同，藥品官方檢驗實驗室是否控制來自承建商的產(chǎn)品1.1.9(4.1.5h)

23、 Name of the technical manager who has the overall responsibility for the operation of the laboratory.指派一名對實驗室的運作負(fù)有全面責(zé)任的技術(shù)經(jīng)理。1.1.10(4.1.5h) Are the qualifications (training, courses, publications, experience) of the technical manager documented?技術(shù)經(jīng)理是否有資格對（培訓(xùn)，課程，出版物和經(jīng)歷）進行記錄？1.1.11(4.1.5h/4.2.6) Is th

24、e area of competence of the technical manager defined? 是否對技術(shù)經(jīng)理的職權(quán)范圍進行了界定？1.1.12(4.1.5j) Has a deputy technical manager been appointed?是否有副技術(shù)經(jīng)理被任命？1.1.13(4.1.5i) Name of the quality manager responsible for the follow up of the prescribed working procedures and of the management system指派質(zhì)量經(jīng)理負(fù)責(zé)跟進規(guī)定的工作程

25、序和管理制度。1.1.14(4.1.5i) Are the qualifications (training, courses, publications, experience) of the quality manager documented?質(zhì)量經(jīng)理是否有資格對（培訓(xùn)，課程，出版物和經(jīng)歷）進行記錄？1.1.15(4.1.5/4.2.6) Is the area of competence of the quality manager defined?是否對質(zhì)量經(jīng)理的職權(quán)范圍進行了界定？1.1.16(4.1.5j) Has a deputy quality manager been ap

26、pointed?是否有副質(zhì)量經(jīng)理被任命？1.1.17(4.1.5i) Does the quality manager have direct access to the highest level of management for the laboratory?質(zhì)量經(jīng)理是否能直接進入實驗室的最高管理層？1.1.18(4.1.5k) Is it ensured that personnel are aware of the relevance and importance of their activities and how they contribute to the achieveme

27、nt of the objectives of the management system?是否能確保工作人員意識到他們活動的相關(guān)性和重要性，是否能確保他們有助于管理體系目標(biāo)的實現(xiàn)？1.1.19(4.1.6) Have appropriate communication processes been established within the laboratory?實驗室是否有建立合理的溝通過程？1.1.20(4.1.6) Does communication regarding the effectiveness of the management system takes place?對

28、管理體系的有效性是否進行了溝通？2. Management System 管理體系Y 是N否References / Comments參考/評論2.1 Management system (4.2)2.1.1(4.2.1) Has the OMCL established and implemented a management system covering the full range of activities for which an audit is requested?藥品官方檢驗實驗室是否建立并實施了一個覆蓋審計要求的全部活動范圍的管理體系？2.1.2(4.2.1)Is the

29、management system documented to the requiredextent?管理體系是否已記錄到所需程度？2.1.3(4.2.1)Has the documentation been made available to all staff members concerned? 文件是否已受到工作人員的關(guān)注？2.1.4(4.2.1)Have the staff members understood the managementsystem?工作人員是否了解這個管理體系？2.1.5(4.2.2)Are the various steps of the management

30、 system, including a quality policy statement, documented in a quality manual (QM)? 管理體系的各個步驟，包括質(zhì)量政策聲明，是否在質(zhì)量手冊中有所記錄？2.1.6(4.1.3)Does the management system cover all the activities of the OMCL that are performed inside and outside the permanent and mobile facilities for which the audit is requested?

31、覆蓋官方藥品檢驗實驗室所有活動的管理體系，是否為審計要求在內(nèi)外設(shè)置了永久性和可移動的設(shè)施？2.1.7(4.2.2)Has the responsible management defined in writing the quality policies and objectives? 在修訂質(zhì)量政策和目標(biāo)時，是否對有責(zé)任的管理進行了定義？2.1.8(4.2.2)Are overall objectives established, and are they reviewed during management review? 是否建立了總體目標(biāo)，在管理審查時是否進行了復(fù)審？2.1.9(4.2

32、.2)Does the quality policy statement include at least thefollowing:質(zhì)量政策聲明是否至少包括以下內(nèi)容：a) the laboratory managements commitment to goodprofessional practice and quality of the testing,1）對實驗室管理需承諾有良好的專業(yè)實踐和質(zhì)量檢測b) a statement of the managements intentions withrespect to the standard of service the laborat

33、ory willprovide,2）管理目的的聲明，需提供關(guān)于服務(wù)實驗室的標(biāo)準(zhǔn)c) the purposes of the management system,3）管理體系的目的d) a requirement that all personnel concerned with testingactivities within the laboratory familiarise themselves withthe quality documentation and implement the policies andprocedures in their work,4）要求所有人員在實驗室

34、中熟悉有關(guān)的測試活動，以及在工作中的質(zhì)量文件和政策過程的實施e) the laboratory managements commitment tocompliance with the international standard ISO/IEC17025and to continually improve the effectiveness of themanagement system?5）實驗室管理要承諾遵守檢測和校準(zhǔn)實驗室能力的通用要求的國際標(biāo)準(zhǔn)，并不斷完善管理體系的有效性2.1.10(4.2.3)Has the top management provided evidence of

35、commitment to the development and implementation of the management system and to continually improve its effectiveness?最高管理部門是否能承諾發(fā)展和實施管理體系并不斷完善其有效性？2.1.11(4.2.4)Has the top management communicated to the organisation the importance of meeting authority requirements as well as statutory and regulato

36、ry requirements?最高管理部門是否向組織傳達了會議權(quán)威以及法律法規(guī)要求的重要性？2.1.12(4.2.5)Does the quality manual include or make reference to all the technical and supporting procedures, requirements and rules, and does it outline the structure of the documentation used in the management system?質(zhì)量手冊是否包括或參考了所有的技術(shù)，配套程序，以及要求和規(guī)則？是否

37、概述了在管理系統(tǒng)中使用的文件結(jié)構(gòu)？2.1.13(4.2.7)Is it ensured that the integrity of the management system is maintained when changes to the management system are planned and implemented?當(dāng)要變更已策劃和實施的管理體系時，是否能保證維護后管理體系的穩(wěn)定性？2.2 Document control (4.3)文件控制2.2.1(4.3.1)Is a procedure established to control all documents (of

38、both internal and external origin) that are necessary for the correct performance of testing operations?是否建立程序來控制對正確實行檢驗操作有必要的文件（包括內(nèi)部和外部來源）2.2.2(4.3.2.1)Does the procedure specify who is responsible for the establishment, review, approval for use and maintenance of the management system documents?是否

39、指定程序來負(fù)責(zé)管理體系文件的編制，審查，批準(zhǔn)使用和維修？2.2.3(4.3.2.1)Is there a list, table or equivalent system for identifying all management system documents, with the current revision status and distribution?在當(dāng)前的修訂狀態(tài)和分布下，是否有列表、表格、或是類似的系統(tǒng)來識別管理系統(tǒng)文件？2.2.4(4.3.2.2) 程序是否能確保：a) authorised editions of appropriate documents areav

40、ailable at all locations where operations essential to theeffective functioning of the laboratory are performed,1）適當(dāng)文件的授權(quán)版本在所有位置都可用，這些位置是實驗室有效運作操作說必需的b) documents are periodically reviewed and wherenecessary revised to ensure continuing suitability andcompliance with applicable requirements,2）文件需定期審

41、查，并在必要時修訂以確保持續(xù)的適應(yīng)性，同時要遵守適用要求c) invalid or obsolete documents are promptly removedfrom all points of issue or use, or otherwise assuredagainst unintended use,3)及時從發(fā)行或使用過程中刪除所有無效或過期的文件，否則需確保無誤用d) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked?4）無論是對

42、于法律還是知識保存目的，過期文件的保留需進行適當(dāng)記錄2.2.5(4.3.2.3) Are all management system documents clearly identified?是否所有管理文件已明確界定？a) the date of issue and/or approval for use,1）發(fā)行和/或批準(zhǔn)使用之日起b) the page numbers and the total number of pages,2）頁碼和總頁數(shù)c) the persons authorised for issuing the documents?3）發(fā)行文件的授權(quán)人2.2.7(4.3.3

43、.1)Are the responsibilities and authorities for the revision and amendment of documents clearly and suitably defined?對于文件的修訂和修正是否能清楚并合適地界定其職責(zé)和權(quán)限？2.2.8(4.3.3.1)Has a procedure been established for the amendment of documents?對于文件的修訂是否已建立程序？2.2.9(4.3.3.2) Are the changes made in documents clearly ident

44、ified?文件中的更改是否可以清楚辨認(rèn)？2.2.10(4.3.3.2) Is it possible to trace the changes made in documents?是否可以追蹤文件所做的更改？2.2.11(4.3.3.3)Is the amendment of documents by hand allowed? If yes, has a procedure been defined for such amendments?是否允許手工修改文件？如果可以，是否已確定了修改程序？2.2.12(4.3.3.4)Is there an established procedure

45、to describe how changes are to be made in documents maintained in computerised systems?是否建立了程序來描述如何對電腦系統(tǒng)中保存的文件進行變更？2.3 Record control (4.13)記錄控制2.3.1 Is there a procedure for XX of quality and technical records?:是否有一個質(zhì)量技術(shù)記錄的XX程序：（4.13.1.1) a) identification,1）鑒定b) collection, 2）收集c) registration, 3）

46、登記d) access, 4）獲取e) indexing, 5）索引f) storage, 6）保存g) maintenance, 7）維護h) retrievability, 8）檢索i) legibility 9）易讀性2.3.2(4.13.1.2)Is there a procedure for the archiving of such records including the definition of minimum retention times?是否有一個記錄保存程序，包括確定最少保留時間？2.3.3(4.13.1.3)Are records handled in confi

47、dence and held safely protected from loss and damage?是否有信心處理記錄，以及對損失和損壞的安全保護？2.3.4(4.13.1.4)Is there a procedure for the protection and safeguarding of data held on computers?是否有程序來保護和維護計算機上的數(shù)據(jù)？2.3.5(4.1.5c)Has the laboratory established rules to ensure the protection of its authoritys confidential

48、information and proprietary rights, and do these rules also cover the electronic storage and transmission of data?實驗室是否有建立規(guī)則，以確保其權(quán)威的機密信息和專有權(quán)利得到保護，這些規(guī)則是否也覆蓋了電子存儲和數(shù)據(jù)傳輸？3. External Cooperation(with competent authorities and suppliers)對外合作（與主管部門和供應(yīng)商）Y 是N否References / Comments參考/評論3.1 Testing order revie

49、w (4.4)3.1.1(4.4.1)Has the OMCL established procedures for the review and internal handling of testing orders arriving from the competent authorities?藥品官方檢驗實驗室是否為來自主管機構(gòu)的測試要求的審查和內(nèi)部控制建立了程序3.1.2(4.4.1) Do these procedures ensure that:這些程序是否能保證：a) testing orders are only accepted where therequirements i

50、ncluding the methods to be used areadequately defined and documented,1）測試次序只接受包括充分界定和記錄要使用方法的要求b) the laboratory has the technical capability andresources to meet the requirements,2）實驗室有技術(shù)能力和資源來符合要求c) the appropriate test methods are selected and capableof meeting the authoritys requirements?3）選擇合適的

51、測試方法和符合管理機構(gòu)要求的能力3.1.3(4.4.1)Is it ensured that any differences between the testing order and the testing possibilities of the OMCL are resolved before any work commences?是否能夠確保藥品官方檢驗實驗室的檢測次序和檢測可能性之間的任何不同， 能夠在任何工作開始之前解決？3.1.4(4.4.2)Are records also maintained of any technical advice to the authority

52、in relation to testing?是否也保留了對有關(guān)檢測管理機構(gòu)的任何技術(shù)意見記錄？3.1.5(4.4.3)Does the testing order review also cover any work to be subcontracted by the laboratory?是否檢測次序?qū)徲嫼w了實驗室分包的任何工作？3.1.6(4.4.4)Is any departure from the contract or agreed testing order reported to the authority, even if occurring after work has

53、 commenced?是否向管理機構(gòu)報告任何違背合同或是違背已同意的測試次序，即使是在工作開始后發(fā)生的？3.2 Subcontracting of tests (4.5)分包測試3.2.1(4.5.3)Is the OMCL aware that it is responsible to the authority for the work of any subcontractor (unless this has been selected by the authority itself)?藥品官方檢驗實驗室是否意識到，對于任何分包商的工作，管理部門需由其負(fù)責(zé)（除非是由管理部門自行選擇）？3.2.2(4.5.2, /OMCL) Is the authority informed in writing, if a subcontractor will be regularly involved in the performance of the testing?如果分包商將定期參與測試的進行，管理部門是否有書面通知？3.2.3(4.5.1)It is ensured that any special arrangements with the authority (confidentiality, specified test methods, etc.) are also t