11+仪器确认+附件1+HPLC确认+中英文+完.doc

OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (11) 04 QUALIFICATION OF EQUIPMENT 仪器确认 ANNEX 1: QUALIFICATION OF HPLC EQUIPMENT 附件1：HPLC仪器的确认 Full document title and reference 文件全名和索引号 Qualification of Equipment Annex 1: Qualification of HPLC equipment 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 Date of first adoption 首次发行日期 May 2005 Date of original entry into force 首次执行日期 June 2005 Date of entry into force of revised document 修订后执行日期 1st July 2011 Previous titles/other references 原文件名/其它索引号 This document replaces document PA/PH/OMCL (07) 17 DEF Custodian Organisation 保管机构 The present document was elaborated by the OMCL Network/ EDQM of the Council of Europe Concerned Network 相关网络 GEON  ANNEX 1 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” OMCL网络指南“仪器的确认”之附件1 QUALIFICATION OF HPLC EQUIPMENT HPLC仪器的确认 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“仪器的确认”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. 核心文件包括了第一级和第二级确认的通用介绍，适用于所有类型的仪器，本附件包括了HPLC仪器相关的需要检查的参数和相应典型的可接受标准的推荐，以及可用于进行这此检查的实用方法学举例。 When qualifying HPLC equipment, it should be noted that it is acceptable to check at Level III and IV several of the mentioned parameters at the same time in a combined test procedure