HPLC设备的确认(中英)QualificationofHPLCEquipment….docVIP

OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT 欧洲委员会OMCL网络 质量管理文件 PA/PH/OMCL (11) 04 QUALIFICATION OF EQUIPMENT 设备的确认 ANNEX 1: QUALIFICATION OF HPLC EQUIPMENT 附件1：HPLC (高效液相色谱仪) 设备的确认 Full document title and reference 文件全名和索引号 Qualification of Equipment 设备的确认 Annex 1: Qualification of HPLC equipment PA/PH/OMCL (11) 04 附件1：HPLC设备的确认 PA/PH/OMCL (11) 04 Document 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 OMCLs 本文件也被EA认可并推荐在OMCL的质量管理体系审计中使用。 Date of first adoption 首次采用日期 May 2005 2005年5月 Date of original entry into force 首次生效日期 June 2005 2005年6月 Date of entry into force of revised document 修订版生效日期 1st July 2011 2011年7月1号 Previous titles/other references 原文件名/其它索引号 This document replaces document PA/PH/OMCL (07) 17 DEF 本文件替代文件PA/PH/OMCL (07) 17 DEF Custodian Organisation 监管组织 The present document was elaborated by the OMCL Network/ EDQM of the Council of Europe 本文件由OMCL网络/欧洲EDQM制定。 Concerned Network 相关网络 GEON ANNEX 1 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” OMCL网络指南“设备的确认”之附件1 QUALIFICATION OF HPLC EQUIPMENT HPLC设备的确认 Introduction 概述 The present document is the first Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the HPLC equipment qualification process. 本文件是核心文件“设备的确认”第1个附件，在计划、实施和记录HPLC仪器的确认过程时，应将本文件与核心文件一起使用。 The core document contains the general introduction and the Level I and II of qualification, common to all type of instruments, and the present annex contains HPLC instrument-related recommendations on parameters to be checked and the corresponding typical acceptance Limits, as well as practical examples on the Methodology that can be used to carry out these checks. 核