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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 药品官方控制实验室联合审计标准指南I. General 一、概况This “aide-mmoire” was elaborated on a standard checklist for EN ISO/IEC 17025 and corresponding EA and ILAC guidelines, published
2、 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 accordance with the
3、 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 indication of corres
4、ponding 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. 第一列的问题是针对测试中的实验室；要求实验
5、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, but it will not be us
6、ed 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-assessment of the implementation status of the Management System, independently of any external assessment. 检测和校准实验室能力的通用
7、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 electronic records. 文件，记录：文件和记录可以以纸张或电子（电脑）的形
8、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 gives the order to test a medicinal product NB
9、：官方文件中指：主管机关下令检测药品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 自我评估 YES 是 NO 否Date of self-assessment or MJA 联合审计或自我评估日期If
10、 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 此记录发行者姓名SUMMARY 摘要 (figures in parentheses refer to standard EN ISO/IE
11、C 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(4.13) 3. External co-operation (with competent authorities and suppliers) 对外合作（和主管部门及
12、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 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)
13、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(
14、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 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 m
15、ethod 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)保证检测结果质量 8.5 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
16、 by subcontractors 由分包商进行测试(5.10.6)1. Organisation组织YNReferences/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 tes
