EDQM试验室联合审计标准指引

1、精品资料推荐 2006 年 7 月 EDQM: PA/PH/OMCL (06) 72 (EDIV/04) Standard “Aide m moire ” for the Mutual J Aouindtit of Official Medicines Control Laboratories 药品官方控制实验室联合审计标准指南 I. General 一、概况 This “ aid-em moire ”wa s elaborated on a standard checklist for EN ISO/IEC 17025 and corresponding EA and ILAC guidel

2、ines, published by an accreditation body on the internet. Specific OMCL requirements arising from adopted OMCL guidelines were incorporated. 这个指南是为阐述检测和校准实验室能力的通用要求 和相应的欧洲认证协会及国际实验 室认可合作组织准则的一个标准清单， 并被一个认证机构发表在互联网上。 药品官方检验实 验室的具体要求因被采用的药品官方检验实验室准则而注册成立。 This document has been revised and updated in

3、accordance with the second 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日第二版的检测和校准实验室能力的通用要 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

4、 indication of corresponding reference 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

5、问题是针对测试中的实验室； 要求实验室在评估开始前， 根据文件和相应的参考指 标全部解答， (例如：质量手册，标准操作规程，工作指示等)，从而为核数师提供一个有 效的评估依据。假如任何一个标准的要求不适用，则必须在参考项下注明“不适用”，并用 合理的解释说明。 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,

6、but it will not be used as such to prepare the audit report. 在审计过程中，这份文件为审计人员提供了一个实用的工具， 以确保所有的检测和校准实 验室能力的通用要求 标准以及药品官方检验实验室准则所涵盖的内容， 但文件并不会使用 像这样准备的审计报告。 This document may also be used by OMCLs as self-assessmento f the 精品资料推荐 implementation status of the Management System, independently of any ex

7、ternal assessment. 检测和校准实验室能力的通用要求 也可使用这份文件， 作为管理系统执行情况的自我评 估，它独立于任何的外部评估。 II. Definitions and Abbreviations 二、定义和缩略词 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 electroni

8、c records. 文件，记录：文件和记录可以以纸张或电子(电脑)的形式存储。且必须为电子记录的可用 性、访问和维护定义相应的规章制度。 QM = quality manual QM = 质量手册 OMCL = Official Medicines Control Laboratory OMCL = 药品官方检验实验室 MJA = Mutual Joint Audit MJA = 联合审计 OOS = Out of Specification OOS =超标 NB: in the text ? Authority ? refers to: competent authority that g

9、ives the order to test a medicinal product NB：官方文件中指：主管机关下令检测药品 精品资料推荐 EDQM/OMCL NETWORK MJA AUDIT INFORMATION 欧洲药品管理委员会 /药品官方检验实验室网络联合审计信息 (to be filled in prior to the MJA or during assessment as an audit record) (提前填写，并在联合审计或评估期间作为审计记录) Name of OMCL 药品官方检验实验室名称 MJA Number 联合审计号 Self-assessment 自我

10、评估 ? YES 是 ? NO 否 Date of self-assessment or MJA 联合审计或自我评估日期 If YES date of submission 自我评估项填“有”的，填提交日期 Name of person responsible 负责人姓名 Signature 签名 If NO date of MJA 自我评估项填“否”的，填联合审计日期 Name of MJA team coordinator 联合审计团队协调员姓名 Name of MJA team members 联合审计团队成员姓名 Name of person issuing this record 此

11、记录发行者姓名 精品资料推荐 SUMMARY 摘要 (figures in parentheses refer to standard EN ISO/IEC 17025) (括号中的数字参考检测和校准实验室能力的通用要求标准) 1. Organisation 组织机构 1.1 Organisation and management组 织和管理机构 (4.1) 2. Management system 管理系统 2.1 Management system 管理系统 (4.2) 2.2 Document control 文件监控 (4.3) 2.3 Record control 记录监控 (4.1

12、3) 3. External co-operation (with competent authorities and suppliers) 对外合作(和主管部门及供应商) 3.1 Testing order review 顺序审查检测 (4.4) 3.2 Sub-contracting of tests 分包检测 (4.5) 3.3 Purchasing services and supplies采 购服务和供应 (4.6) 3.4 Service to the authority 服务管理机构 (4.7) 3.5 Complaints 起诉 (4.8) 4. Maintenance of

13、the management system 管理系统的维护 4.1 Control of nonconforming testing work 控制不合格检测工作 (4.9) 4.2 Improvement 改善 (4.10) 4.3 Corrective action 纠正措施 (4.11) 4.4 Preventive action 预防措施 (4.12) 4.5 Internal audits 内部审计 (4.14) 4.6 Management reviews 管理审查 (4.15) 5. Personnel 人员 (5.2) 6. Premises and equipment 物业及

14、设备 6.1 Premises 物业 (5.3) 6.2 Equipment 设备 (5.5) 6.3 Computer system, control of data 计算机系统，数据控制 (5.4) 6.4 Measurement traceability 可追溯性测量 (5.6) 6.5 Reference standards参 考标准 (5.6/OMCL) 7. Handling of test items 检测项目处理 7.1 Sampling 取样 (5.7) 7.2 Handling of test items 检测项目处理 (5.8) 8. Test methods 检测方法

15、8.1 Test methods and procedures, including validation (5.4) 检测方法和程序，包括验证 8.2 Questions relevant for method transfer and screening 有关问题的方法转让和筛选 (5.4/OMCL) 8.3 Questions relevant for laboratory-developed methods (5.4) 有关问题的实验室开发方法 8.4 Assuring the quality of test results (5.9/OMCL) 精品资料推荐 保证检测结果质量 8.5

16、 Technical records (4.13.2) 技术记录 9. Test reports 检测报告 9.1 Reporting the results 报告结果 (5.10) 9.2 Tests performed by subcontractors由 分包商进行测试 (5.10.6) 精品资料推荐 1. Organisation 组织 Y N References/Comments 参 考 / 评论 1.1 Organisation and management (4.1) 组织和 管理 1.1.1 (4.1.1) - Name and address of the OMCL 药品官

17、方检验实验室的名称和地址 -Legal identity of the organisation (entry in the commerce register or public institution) 该组织的合法身份(登记在商业注册处或公 共机构) -Field of activities of the OMCL 药品官方检验实验室现场活动 o Market surveillance testing 市场监督检测 o Official Batch release testing 官方批放行检测 o -Name and address of the laboratory 实验室的名称和地

18、址 -Field of activities of the laboratory (general) 实验室现场活动(一般) Has the OMCL already been accredited? 该药品官方实验室是否已经被认可？ If YES, scope for which accreditation has been granted and by which accreditation body 如果已被认可，获资格认证的范围，且被 哪个机构认证 If NO, scope of the applied Management System 如果未被认可， 这个应用管理系统的范围 Sco

19、pe of activities to be audited during the MJA 联合审计期间的活动审计范围 1.1.2 (4.1.4) Is the laboratory part of a parent organisation? If YES what organisation? 这个实验室是否是上级组织的一部分？ 如果是，是什么组织 1.1.3 (4.1.5e) Is there one or several organisational chart(s) for the whole OMCL showing the position of the testing labor

20、atory, and is such a chart available for the testing laboratory itself? 6 精品资料推荐 是否有一个或是数个组织结构图， 为药 品官方实验室显示该检测实验室的位 置，且这种图标是否能供实验室本身使 用？ 1.1.4 (4.1.4) Are the responsibilities and authorities of the key personnel in the laboratory suitably defined so that conflicts of interest can be avoided? 是否界定了

21、实验室中关键人员的责任 和权力，来避免利益冲突？ 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? 是否可以排除由个人或机构进行的外部 检测而对结果造成的任何影响？ 1.1.6 Is it ensured that the OMCL is not engaged in other activities that may endanger its impartiality, its

22、independence and its integrity? 是否能保证药品官方检验实验室没有 从事其他可能危及其公正性， 独立性和 完整性的活动？ 1.1.7 (4.1.5b) Is the technical and financial independence between the laboratory and external customers ensured? 在实验室和外部客户之间是否能确保 技术和经济的独立？ 1.1.8 (药品官方 How is it ensured that the OMCL performs the 检验实验室 ) testing of product

23、s independently from any contract work by order of a pharmaceutical manufacturer or entrepreneur? 如何确保药品官方检验实验室对来自 任何药品生产商或企业家的合同要求 进行独立的产品测试？ See contracts with other customers, see if the OMCL controls products from the contractor 看看其他客户的合同， 药品官 方检验实验室是否控制来自 承建商的产品 1.1.9 (4.1.5h) Name of the techn

24、ical manager who has the overall responsibility for the operation of the laboratory. 7 精品资料推荐 指派一名对实验室的运作负有全面责 任的技术经理。 1.1.10 (4.1.5h) Are the qualifications (training, courses, publications, experience) of the technical manager documented? 技术经理是否有资格对(培训，课程， 出版物和经历)进行记录？ 1.1.11 (4.1.5h/ 4.2.6) Is th

25、e area of competence of the technical manager defined? 是否对技术经理的职权范围进行了界 定？ 1.1.12 (4.1.5j) Has a deputy technical manager been appointed? 是否有副技术经理被任命？ 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 指派质量经理负责跟

26、进规定的工作程 序和管理制度。 1.1.14 (4.1.5i) Are the qualifications (training, courses, publications, experience) of the quality manager documented? 质量经理是否有资格对(培训，课程， 出版物和经历)进行记录？ 1.1.15 (4.1.5/ 4.2.6)Is the area of competence of the quality manager defined? 是否对质量经理的职权范围进行了界 定？ 1.1.16 (4.1.5j) Has a deputy quali

27、ty manager been appointed? 是否有副质量经理被任命？ 1.1.17 (4.1.5i) Does the quality manager have direct access to the highest level of 8 精品资料推荐 management for the laboratory? 质量经理是否能直接进入实验室的最 高管理层？ 1.1.18 (4.1.5k) Is it ensured that personnel are aware of the relevance and importance of their activities and ho

28、w they contribute to the achievement of the objectives of the management system? 是否能确保工作人员意识到他们活动 的相关性和重要性， 是否能确保他们有 助于管理体系目标的实现？ 1.1.19 (4.1.6) Have appropriate communication processes been established within the laboratory? 实验室是否有建立合理的沟通过程？ 1.1.20 (4.1.6) Does communication regarding the effective

29、ness of the management system takes place? 对管理体系的有效性是否进行了沟通？ 2. Management System 管理体系 Y 是 N 否 References / Comments 参考 /评论 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? 药品

30、官方检验实验室是否建立并实施了一 个覆盖审计要求的全部活动范围的管理体 系？ 2.1.2 (4.2.1)Is the management system documented to the required extent? 管理体系是否已记录到所需程度？ 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员的关注？ 2.1.4 (4.2.1)Have the staff members understood the 9 精品资料推荐 managemen

31、t system? 工作人员是否了解这个管理体系？ 2.1.5 (4.2.2)Are the various steps of the management system, including a quality policy statement, documented in a quality manual (QM)? 管理体系的各个步骤，包括质量政策声明， 是否在质量手册中有所记录？ 2.1.6 (4.1.3)Does the management system cover all the activities of the OMCL that are performed inside a

32、nd outside the permanent and mobile facilities for which the audit is requested? 覆盖官方药品检验实验室所有活动的管理 体系，是否为审计要求在内外设置了永久性 和可移动的设施？ 2.1.7 (4.2.2)Has the responsible management defined in writing the quality policies and objectives? 在修订质量政策和目标时， 是否对有责任的 管理进行了定义？ 2.1.8 (4.2.2)Are overall objectives estab

33、lished, and are they reviewed during management review? 是否建立了总体目标， 在管理审查时是否进 行了复审？ 2.1.9 (4.2.2)Does the quality policy statement include at least the following: 质量政策声明是否至少包括以下内容： a) the laboratory management s commitment good professional practice and quality of the testing, 1)对实验室管理需承诺有良好的专业实践和质量

34、检测 to b) a statement of the management s intenti respect to the standard of service the laboratory will provide, 2)管理目的的声明， 需提供关于服务实验室的标 准 ns wit h c) the purposes of the management system, 3)管理体系的目的 10 精品资料推荐 d) a requirement that all personnel concerned with testing activities within the laborator

35、y familiarise themselves with the quality documentation and implement the policies and procedures in their work, 4)要求所有人员在实验室中熟悉有关的测试活 动，以及在工作中的质量文件和政策过程的实施 e) the laboratory management s commitment compliance with the international standard ISO/IEC17025 and to continually improve the effectiveness

36、of the management system? 5)实验室管理要承诺遵守 检测和校准实验室能 力的通用要求的国际标准，并不断完善管理体 系的有效性 to 2.1.10 (4.2.3)Has the top management provided evidence of commitment to the development and implementation of the management system and to continually improve its effectiveness? 最高管理部门是否能承诺发展和实施管理 体系并不断完善其有效性？ 2.1.11 (4.2

37、.4)Has the top management communicated to the organisation the importance of meeting authority requirements as well as statutory and regulatory requirements? 最高管理部门是否向组织传达了会议权威 以及法律法规要求的重要性？ 2.1.12 (4.2.5)Does the quality manual include or make reference to all the technical and supporting procedure

38、s, requirements and rules, and does it outline the structure of the documentation used in the management system? 质量手册是否包括或参考了所有的技术， 配 套程序，以及要求和规则？是否概述了在管 理系统中使用的文件结构？ 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 11 精品

39、资料推荐 planned and implemented? 当要变更已策划和实施的管理体系时， 是否 能保证维护后管理体系的稳定性？ 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 both internal and external origin) that are necessary for the correct performance of testing operations? 是否建立程序来控制对正确实行检验操作 有必要的文件(包

40、括内部和外部来源) 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? 是否指定程序来负责管理体系文件的编 制，审查，批准使用和维修？ 2.2.3 (4.3.2.1)Is there a list, table or equivalent system for identifying all management system

41、documents, with the current revision status and distribution? 在当前的修订状态和分布下，是否有列 表、表格、或是类似的系统来识别管理系 统文件？ 2.2.4 (4.3.2.2) 程序是否能确保： a) authorised editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed, 1)适

42、当文件的授权版本在所有位置都可用， 这些 位置是实验室有效运作操作说必需的 b) documents are periodically reviewed and where necessary revised to ensure continuing suitability and compliance with applicable requirements, 2)文件需定期审查， 并在必要时修订以确保持续 的适应性，同时要遵守适用要求 c) invalid or obsolete documents are promptly removed from all points of issue

43、 or use, or otherwise assured 12 精品资料推荐 against unintended use, 3）及时从发行或使用过程中删除所有无效或过期 的文件，否则需确保无误用 d) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked? 4)无论是对于法律还是知识保存目的， 过期文件 的保留需进行适当记录 2.2.5 (4.3.2.3) Are all management system documents clearly i

44、dentified? 是否所有管理文件已明确界定？ a) the date of issue and/or approval for use, 1)发行和 /或批准使用之日起 b) the page numbers and the total number of pages, 2)页码和总页数 c) the persons authorised for issuing the documents? 3)发行文件的授权人 2.2.7 (4.3.3.1)Are the responsibilities and authorities for the revision and amendment o

45、f documents clearly and suitably defined? 对于文件的修订和修正是否能清楚并合 适地界定其职责和权限？ 2.2.8 (4.3.3.1)Has a procedure been established for the amendment of documents? 对于文件的修订是否已建立程序？ 2.2.9 (4.3.3.2) Are the changes made in documents clearly identified? 文件中的更改是否可以清楚辨认？ 2.2.10 (4.3.3.2) Is it possible to trace the c

46、hanges made in documents? 是否可以追踪文件所做的更改？ 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? 是否允许手工修改文件？如果可以， 是否 已确定了修改程序？ 2.2.12 13 精品资料推荐 (4.3.3.4)Is there an established procedure to describe how changes are to be made in docume

47、nts maintained in computerised systems? 是否建立了程序来描述如何对电脑系统 中保存的文件进行变更？ 2.3 Record control (4.13) 记录控制 2.3.1 Is there a procedure for XX of quality and technical records?: 是否有一个质量技术记录的 XX 程序： ( 4.13.1.1) a) identification,1 )鉴定 b) collection,2)收集 c) registration,3)登记 d) access,4)获取 e) indexing,5)索引 f)

48、 storage,6)保存 g) maintenance,7)维护 h) retrievability,8)检索 i) legibility9)易读性 2.3.2 (4.13.1.2)Is there a procedure for the archiving of such records including the definition of minimum retention times? 是否有一个记录保存程序，包括确定最 少保留时间？ 2.3.3 (4.13.1.3)Are records handled in confidence and held safely protected

49、 from loss and damage? 是否有信心处理记录，以及对损失和损 坏的安全保护？ 2.3.4 (4.13.1.4)Is there a procedure for the protection and safeguarding of data held on computers? 是否有程序来保护和维护计算机上的数 据？ 2.3.5 (4.1.5c)Has the laboratory established rules to ensure the protection of its authority s confidential information and propri

50、etary rights, and do these rules also cover the electronic storage and transmission of data? 实验室是否有建立规则，以确保其权威的 机密信息和专有权利得到保护，这些规则 是否也覆盖了电子存储和数据传输？ 14 精品资料推荐 3. External Cooperation (with competent authorities and suppliers) 对外合作(与主管部门和供应商) Y 是 N 否 References / Comments 参考 /评论 3.1 Testing order revi

51、ew (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? 药品官方检验实验室是否为来自主管机构 的测试要求的审查和内部控制建立了程序 3.1.2 (4.4.1) Do these procedures ensure that: 这些程序是否能保证： a) testing orders are only accepted where the requ

52、irements including the methods to be used are adequately defined and documented, 1)测试次序只接受包括充分界定和记录要使用方 法的要求 b) the laboratory has the technical capability and resources to meet the requirements, 2)实验室有技术能力和资源来符合要求 c) the appropriate test methods are selected and capable of meeting the authority s r

53、equirements? 3)选择合适的测试方法和符合管理机构要求的能 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? 是否能够确保药品官方检验实验室的检测 次序和检测可能性之间的任何不同， 能够 在任何工作开始之前解决？ 3.1.4 (4.4.2)Are records also maintained of any techni

54、cal advice to the authority in relation to testing? 是否也保留了对有关检测管理机构的任何 技术意见记录？ 3.1.5 (4.4.3)Does the testing order review also cover any work to be subcontracted by the laboratory? 是否检测次序审计涵盖了实验室分包的任 何工作？ 15 精品资料推荐 3.1.6 (4.4.4)Is any departure from the contract or agreed testing order reported to t

55、he authority, even if occurring after work has commenced? 是否向管理机构报告任何违背合同或是违 背已同意的测试次序， 即使是在工作开始后 发生的？ 3.2 Subcontracting of tests (4.5) 分包测试 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 itsel

56、f)? 药品官方检验实验室是否意识到， 对于任何 分包商的工作， 管理部门需由其负责 (除非 是由管理部门自行选择)？ 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? 如果分包商将定期参与测试的进行， 管理 部门是否有书面通知？ 3.2.3 (4.5.1)It is ensured that any special arrangements with the au

57、thority (confidentiality, specified test methods, etc.) are also transmitted to the subcontractor? 是否能确保管理部门(机密性，制定的测 试方法等)的任何特殊安排，都能传达给 分包商？ 3.2.4 (4.5.1)Has the laboratory established a procedure for the selection of subcontractors based on technical and qualitative evaluation criteria? 实验室是否已经为分包

58、商的选择建立了一 个基于技术和定性评价标准的程序 ? 3.2.5 (4.5.1)Does the laboratory regularly verify that the authoritys requirements are fulfilled by the subcontractor? 实验室是否定期检查由分包商完成的管理 部门的要求？ 3.2.6 16 精品资料推荐 (4.5.2)Is the subcontractor an accredited or formally recognized laboratory? Otherwise, is it ensured that the s

59、ubcontractor complies with the relevant requirements of the ISO 17025 norm and the OMCL guidelines? 是分包商认可的还是正式确认的实验室？ 如果不是，是否能确保分包商符合 ISO 17025认证标准和药品官方检验实验室的相 关要求？ 3.2.7 (4.5.1/ 4.5.3) Is the competence for establishing the requirements to be applied to subcontractors defined? 是否界定了将建立的要求应用于分包商的 能

60、力？ 3.2.8 (4.5.4) Is a register maintained of all subcontractors? Does this register give information on subcontractors compliance to standard ISO 17025 and OMCL guidelines? 是否有保存了所有分包商的登记册？这个 登记册是否有分包商对 ISO 17025 标准和 药品官方检验实验室指导的承诺信息 ? 3.3 Purchasing services and supplies (4.6) 购买服务和日常用品 3.3.1 (4.6.