仪器确认 附件 gc确认 中英文doc.doc

OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT 质量保证文件 PA/PH/OMCL (06) 86 DEF QUALIFICATION OF EQUIPMENT 仪器确认 ANNEX 2: QUALIFICATION OF GC EQUIPMENT 附件2：气相色谱仪的确认 Full document title and reference 文件全名和索引号 Qualification of Equipment Annex 2: Qualification of GC Equipment PA/PH/OMCL(06)86DEF Document type 文件类型 Guideline 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 2006 Date of original entry into force 首次执行日期 June 2007 Date of entry into force of revised document 修订后执行日期 October 2006 Previous titles/other references 原文件名/其它索引号 This document replaces part of document PA/PH/OMCL(06)46 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 2 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” OMCL网络指南“仪器确认”附件2 QUALIFICATION OF GC EQUIPMENT 气相色谱仪的确认 Introduction 介绍 The present document is the second Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the GC equipment qualification process. 本文件是核心文件“仪器确认”的第二个附件，在计划、实施和记录气相色谱仪的确认时，应将本文件与核心文件联合使用。 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 GC 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. 核心文件包括了一般介绍和第一级与第二级确认，适用于所有类型的仪器，本附件包括了气相色谱仪相关的建议，包括哪些参数需要检查，相应的典型可接受标准，以及用来进行这些检查的实践方法学例子。 The tests proposed in the Level III and IV of qualification are based on an overall approach, in which several parameters are checked at the same time in a combined test procedure, to obtain information o