EDQAOMCL分析方法验证的指南.docVIP

. . . . 专业资料 PA/PH/OMCL (13) 82 2R 分析方法验证?? ? ? OMCL Network of the Council of Europe 欧洲理事会OMCL网络 GENERAL DOCUMENT 通用文件 PA/PH/OMCL (13) 82 2R VALIDATION OF ANALYTICAL PROCEDURES 检验方法验证 ? Full document title and reference 文件全名和参考号 Validation of Analytical Procedures分析方法验证 PA/PH/OMCL (13) 82 2R 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 OMCL质量管理体系审计 Date of first adoption 首版采用日期 October 1999 1999年10月 Date of original entry into force 原生效日期 February 2000 2000年2月 Date of entry into force of revised document 修订版生效日期 February 2014 2014年2月 Previous titles/other references 原标题/其它参考号 This document replaces document PA/PH/OMCL (05) 47 DEF Former titles/references: PA/PH/OMCL (99) 37 DEF 本文件替代文件PA/PH/OMCL (05) 47 DEF 原文题目/索引号：PA/PH/OMCL (99) 37 DEF Custodian Organisation 责任机构 The present document was elaborated by OMCL Network/EDQM of the Council of Europe 目前文件由OMCL网络/欧洲议会EDQM Concerned Network 相关网络 GEON ? ? VALIDATION OF ANALYTICAL PROCEDURES GUIDELINE FOR OMCLs OMCL分析方法验证指南 INTRODUCTION 概述 The two ICH Guidelines on “Validation of Analytical Procedures: “Definition/ Terminology and Methodology” (Q2A and Q2B) constitute a discussion of the validation characteristics that should be considered during the validation of an analytical procedure (the guideline has also been adopted for veterinary products during VICH discussion). They are primarily addressed to pharmaceutical industry indicating which validation data need to be provided in an application file. These data should demonstrate that the proposed testing and acceptance criteria are sufficiently under control to guarantee reproducible quality of the products at release and adequate control during shelf-life (stability). 两个关于分析方法验证的ICH指南“分析方法的验证”和“定义/术语和方法学”（Q2A和Q2B）包括了一个分析方法验证中应该考虑的验证特性的讨论（该指南在V