质量管理文件 仪器的确认 附件5：自动滴定仪的确认.pdfVIP

PA/PH/OMCL (07) 108 4R - OMCL Guideline on automatic titrators (Annex 5) OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT 质量管理文件 PA/PH/OMCL (07) 108 4R QUALIFICATION OF EQUIPMENT 仪器的确认 ANNEX 5: QUALIFICATION OF AUTOMATIC TITRATORS 附件5：自动滴定仪的确认 Full document title and reference Qualification of Equipment 仪器的确认 文件全名和参考文献 Annex 5: Qualification of automatic titrators 附件5：自动滴定仪的确认 PA/PH/OMCL (07) 108 4R Document type Guideline 文件类型 指南 Legislative basis The previous version of this document was also accepted by EA as 立法基础 recommendation document to be used in the context of Quality Management System audits of OMCLs Date of first adoption June 2008 首次采用日期 Date of original entry into force August 2008 初版生效日期 Date of entry into force of revised 1st May 2012 document 修订本生效日期 Previous titles/other This document replaces document PA/PH/OMCL (07) 108 3R References 本文件替代文件PA/PH/OMCL (07) 108 3R 曾用名/其它参考文献 Custodian Organisation The present document was elaborated by the OMCL Network/ 管理机构 EDQM of the Council of Europe Concerned Network GEON 相关网络 ANNEX 5 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” OMCL 网络指南“仪器确认”附件5 QUALIFICATION OF AUTOMATIC TITRATORS 自动滴定仪的确认 Introduction 介绍 The present document is the 5th Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the qualification process of automatic titrators. 本文件为核心文件“