OMCL仪器确认核心文件-中英文.docx

Network of the Council of EuropeQUALITY MANAGEMENT DOCUMENT质量管理文件PA/PH/OMCL (08) 73 2RQUALIFICATION OF EQUIPMENT仪器确认CORE DOCUMENT核心文件Full document title and reference文件全名和索引号Qualification of Equipment Core document仪器确认核心文件PA/PH/OMCL (08)73 2RDocument type文件类型Guideline指南Legislative basis立法基础The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System audits of OMCLsDate of first adoption首次采用日期1st October 1999Date of original entry into force首次生效日期1st February 2000Date of entry into force of revised document修订版本生效日期1st July 2011Previous titles/other references曾用文件名/索引号This document replaces document PA/PH/OMCL(08)73 RCustodian Organisation管理组织The present document was elaborated by the OMCL Network/EDQM of the Council of EuropeConcerned Network相关网络GEONIntroduction 介绍The standard ISO/IEC 17025 requires an appropriate choice and qualification of equipment to be used for testing purposes. Particularly, checks and calibrations before and during use and, if needed, intermediate tests (see ISO/IEC 17025 chapter 5.5.10) are necessary.ISO/IEC 17025标准要求用于检测的仪器应进行适当的选择和确认，特别是在使用前和使用中应进行检查和校正，必要时应进行中间测试（见ISO/ICE 17025 第5.5.10章节）。In order to guarantee a harmonized interpretation and application within the OMCL Network, the guideline ? Qualification of Equipment ? has been elaborated.为了保证在OMCL网络内的统一解释和应用，特制订此指南仪器确认。From experience, the terms DQ, IQ, OQ and PQ (not explicitly mentioned by ISO/IEC 17025) have been used in a non-harmonized way amongst the different OMCLs. Therefore their mention has been avoided in this document. This does not exclude their use in OMCLs quality systems where already approved and in application, or a reference to literature using thisnomenclature.根据经验，术语DQ, IQ, OQ和PQ（在ISO/IEC 17025中未明确提出）已由非协调方式在不同OMCL中采用，因此在本文中避免对这些术语的使用。但这并不排除OMCL的质量体系在已批准和实际中采用这些术语，或者引用一些使用了这些术语的文献。In order to simplify the management of the guideline, the present document contains only the general introduction and the first two levels of qualification, which are common to all type of equipment. The third and fourth levels of qualification can be found in separate instrument-related annexes. When considered appropriate, additional requirements and/or examples related to Level I and/or Level II have also been included in the annexes, which are to be used in combination with the general recommendations given in the core document.为了简化指南管理，本文件仅包括通用介绍，以及前两个级别的确认，可以适用于所有类型的仪器。第三级和第四级的确认可以在单独的仪器相关的附件中找到。考虑到适用性，附加要求和/或第一级和/第二级的相关举例也列在了附件中，这些内容应与核心文件中的通用推荐结合使用。The list of annexes, included in this document, will be updated as soon as new annexes are issued.如有新附件增加，包括在本文件中的附件清单将同步更新。This document should be considered as a guide to OMCLs for planning, performing and documenting the equipment qualification process. It should not be taken as an exhaustive list of compulsory tests. It is left to the professional judgment and background experience of each OMCL to decide on the most relevant tests and the most appropriate tolerance limits for each of the parameters, in order to give evidence that the instrument is working properly and is appropriate for its intended use.本文件应被作为OMCL的指南，用于计划、实施和记录仪器确认过程。它不应该作为一个必检内容的完全列举清单。各OMCL应根据自己的专业判断和背景经验来决定最相关的测试，每个参数的最合适允许限度，以证明仪器能正常工作，并适合适其使用目的。If the qualification of equipment is done by the manufacturer itself or an external service, it is under the responsibility of the OMCL to make sure that the checks performed are in line with the minimum requirements set in this guideline.如果仪器的确认由供应商提供，或委托外部服务机构进行，那么OMCL有责任保证所进行的检查符合本指南的最低要求。To facilitate the implementation of a documented qualification process for the various analytical instruments, specific recommendations on minimum requirements are given in the corresponding annexes.为方便不同的分析仪器实施和记录确认过程，在相关的附件中给出了针对不同仪器的推荐和最低要求。For the more technique-related aspects of equipment qualification checks, practical examples of possible approaches are also presented in the annexes.对于与技术相关方面的仪器确认检查，在附件中也给出了可能方法的实际例子。The following four levels of Equipment Qualification should be considered by the OMCLs:OMCL应考虑以下四级仪器确认Level I. Selection of instruments and suppliers第一级 仪器和供应商的选择The selection and purchase of new instruments shall follow a conscious decision process, based on the needs related to the intended use of the instrument.新仪器的选择和采购应根据仪器的用途，采用明确的决策流程，An example for setting and documenting such specifications and decisions taken is given in Table I.表一给出了设置和文件的接受标准和决策的例子。Level II. Installation and release for use第二级 安装和放行使用When receiving an instrument, the OMCL should check that it is received in good conditions, as ordered, and should monitor and document the installation process of the instrument in the selected environment. This includes the start up checks done by the supplier, followed by a full periodic check as described in Level III.接收仪器时，OMCL应检查其处于良好状态，与订单一致，并应该监控和记录仪器在选择的环境下进行安装的过程，这里也包括供应商所做的开机检查，以及在第三级检查中描述的全面周期性检查。The release for use shall be documented and authorised by the person responsible for the instrument.仪器放行使用的过程应有记录，并由授权人进行放行。An example for documenting the instrument installation and release for use and decisions taken is given in Table II.在表二中给出了记录仪器安装和放行使用的例子。Level III. Periodic and motivated instrument checks第三级 周期性主动仪器检查When instruments are installed or moved into a new environment a series of checks have to be carried out to verify the key performance parameters of the instrument avoiding additional contributory effects from the analytical method. Depending on the frequency of use and the experienced stability of the instrument this shall be repeated periodically.当仪器安装后，或移动至一个新的环境后，需要确认仪器的关键性能参数，以避免分析方法产生的附加影响。本检查根据仪器使用的频次以及其稳定性情况应该周期性地重复进行。The same verifications (or a relevant part of them) shall be carried out following events like significant repair or maintenance operations.当仪器在经过重大维修或维护后，应该进行相同的确认（或相关部件进行确认）。Examples of parameters to be checked on instruments and their typical acceptance limits can be found in the Table III of the corresponding instrument-related annex.在相应仪器的附件中，表三中列出了一些仪器需要检查的参数及其典型的可接受标准。The specifications from the manufacturer of the instrument should be taken into account when setting the tolerance limits.在设定可接受限度的时候，应考虑仪器供应商所提供的标准。Some examples on how these checks may be performed on each type of instrument are also provided in the corresponding Annexes.在相应的附件中给出了记录仪器安装和放行使用的例子。Level IV. In-use instrument checks第四级 在用仪器检查During the day-to-day use of the instruments, checks are necessary to demonstrate continued evidence of satisfactory performance by the instrument itself and compliance with the system suitability criteria as defined in the applied analytical procedure for each product or group of products tested at this occasion.在仪器日常使用中，有必要对仪器本身性能满意性进行持续检查，以及在此情况下单个产品或一类产品所用方法的系统适用性检查。Examples of parameters to be checked on instruments and their typical acceptance limits can be found in the Table IV of the corresponding instrument-related annex.在相应仪器的附件表四可以找到需要检查的仪器参数及其典型可接受限度。In the case of OMCLs performing routine testing (Type A: batch release of vaccines and blood products), the use of control charts provides supplementary information on equipment performance, which can also be used in this context.如果OMCL在进行常规测试（类型A：疫苗和血液制品批放行），采用控制图表所提供的仪器性能的补充信息也可以采用。List of instrument-related annexes 仪器相关附件清单The qualification levels dealt with in each annex are indicated in brackets.各附件内容包括的确认级别在括号内说明? Annex 1: Qualification of HPLC equipment (Levels III and IV) 附件1：HPLC仪器确认（第三级和第四级）? Annex 2: Qualification of GC equipment (Levels III and IV) 附件2：GC仪器确认（第三级和第四级）? Annex 3: Qualification of UV-Visible spectrophotometers (Levels I, III and IV)附件3：紫外-可见光谱仪确认（第一级、第三级和第四级）? Annex 4: Qualification of IR spectrophotometers (Levels I, III and IV)附件4：红外光谱仪确认（第一级、第三级和第四级）? Annex 5: Qualification of automatic titrators (Levels III and IV)附件5：自动滴定仪确认（第三级和第四级）? Annex 6: Qualification of piston pipettes (Levels III and IV)附件6：活塞移液管确认（第三级和第四级）? Annex 7: Qualification of mass spectrometers (Levels III and IV)附件7：质谱仪确认（第三级和第四级）TABLE I 表1Level I. Selection of instruments and suppliers第一级 仪器和供应商选择Example of check-list (non-exhaustive)检查清单举例（未尽列举）Manufacturer:生产商：Provider/Distributor:供应商/分销商：Name of instrument and type:仪器名称/型号Attribute 特征(this list may be adapted if necessary必要时可以采用此清单)Specifications可接受标准Benefits优点(instrument/supplier)（仪器/供应商）Assessment评估Pass通过Fail不通过Technique 技术Communication and data handling 沟通及数据处理Interface RS232RS232接口Data transfer to spread sheets数据转移至数据表Compatible with other hardware and software such as LIMS与其它硬软件的兼容性，例如LIMS系统Safety 安全Irradiation 辐射Explosion protection 暴露保护Documentation 文件Manual (paper copy)手册（纸质件）Handling 操作User language 用户界面语言Service and maintenance服务和维护Services offered提供的服务Warranty 保证Support 支持Delivery (duration etc.)发货（时长等）Installation 安装(Service服务/Laboratory实验室 )Training (In house/external courses) 培训（内/外训课程）Requirements for media and environment要求的支持条件和环境Cost / Benefit Analysis性价比分析Comments / Decisions建议/决定Date / Signature:日期/签名：Date / Signature for approval:日期/批准签名：TABLE IILevel II. Installation and release for use第二级 安装及放行使用Example of check-list (non-exhaustive)检查清单举例（未尽列举）Name of instrument and type:仪器名称和型号Identification code:编号Conformity with order (instrument / material / documentation)与订单符合性（仪器/材质/文件）Pass通过Fails (description of deficiencies)未通过（缺陷描述）Check of damages损伤检查Pass通过Fails (description of deficiencies)未通过（缺陷描述）Check of required media supply (connections / environmental conditions)要求环境检查（连接/环境条件）Pass通过Fails (description of deficiencies)未通过（缺陷描述）Installation of instrument(s) including possible control modules仪器安装，包括可能的控制模块Pass通过Fails (description of deficiencies)未通过（缺陷描述）Performance of start-up checks and diagnosis functions (1)开机性能检查和对话功能（1）Pass通过Fails (description of deficiencies)未通过（缺陷描述）(1) If available 如有Comments 建议When appropriate, raw data are attached to the instrument documentation如果可行，原始数据应附于仪器档案。Date / Signature:日期/签名：Release and authorisation for use: Date / Signature:可以放行使用：日期/签名：Disclaimer: 申明The present Core Document of the OMCL Guideline “Qualification of Equipment”, as well as all its Annexes, have been drafted by ad-hoc working groups of technical experts, mainly coming from Official Medicines Control Laboratories (OMCLs) and only occasionally from other public institutions. These working groups do not include any representative from any commercial organisatio