仪器确认4红外确认中英文.docVIP

OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT 质量保证文件 PA/PH/OMCL (07) 12 DEF CORR QUALIFICATION OF EQUIPMENT 仪器确认 ANNEX 4: QUALIFICATION OF IR SPECTROPHOTOMETERS 附件4 红外分光光度计的确认 Full document title and reference 文件全名和索引号 Qualification of Equipment 仪器确认 Annex 4: Qualification of IR sepctrophotometers 附件4：红外分光光度计确认 PA/PH/OMCL(07)12 DEF CORR 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 首次采用日期 May 2007 Date of original entry into force 首次生效日期 July 2007 Date of entry into force of revised document 修订生效日期 December 2007 Previous titles/other references 曾用文件名/其它索引号 This document replaces document PA/PH/OMCL(07) 12 DEF Cutodian organisation 管理机构 The present document was elaborated by the OMCL Network/EDQM of the Council of Europe Concerned Network 相关网络 GEON ANNEX 4 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” OMCL网络指南“仪器确认”附件4 QUALIFICATION OF IR SPECTROPHOTOMETERS 红外分光光度计的确认 Introduction 介绍 The present document is the fourth Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the IR spectrophotometer qualification process. 本文件为“仪器确认”核心文件的第四个附件，在对红外分光光度计确认过程进行计划、实施和记录时，应结合该核心文件一起使用。 The core document contains the Introduction and general forms for Level I and II of qualification, which are common to all type of instruments. 核心文件包括了第一级和第二级确认的介绍和通用表格，该表格通用于各类型仪器。 For FTIR spectrometers, an example has been added to give instrument-specific proposals that may be used in combination with the general requirements presented in the core document “Qualification of Equipment”, when drawing up a Level I checklist. 对于傅立叶红外变换光度计，在本指南中给出一个仪器专用的方案，在起草第一级检查清单时，与“仪器确认”核心文件中的第一级通用表格一起使用。 The present annex contains instrument-related recommendations on parameters to be checked at Level I