who分析方法验证文件草案说课讲解.pdf

[技术帖 ] WHO 公布 "验证指南附录 4: 分析方法验证文件 草案 2016-08-01JuliaBlog 洛施德 GMP 咨询 洛施德 GMP 咨询 WHO Draft on Analytical Method Validation WHO 分析方法验证草案 In June 2016 the World Health Organization (WHO) published a draft document "Guidelines on Validation - Appendix 4 Analytical Method Validation". Comments on the text should be sent to WHO until July 30, 2016. 在 2016 年 6 月，WHO 公布了 “验证指南 附录 4 ：分析方法验证 ”文件草案。 征求意见 截止日期为 2016 年 7 月 30 日。 The appendix 4 of the published Supplementary guidelines on good manufacturing practices: validation (WHO Technical Report Series, No. 937, 2006, Annex 4) has been revised in view of current trends in validation. The appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in the Appendix may be followed and may be acceptable. 已发布的 “GMP增补指南：验证 ”的附录 4 （WHO 技术报告第 937 号，附录 4 ）已经根 据目前验证趋势进行了修订。附录里给出一些分析方法验证中需要考虑的特性信息。 除了在附录里指定的方法以外，其它方法也可以采用。 The new Appendix 4 is structured as follows (New and revised): 新的附录 4 结构如下（新的修订过后的）： 1. Principle (revised): 原则 （修订过） o 1.5 The recommendations as provided for in good laboratory practices and guidelines for transfer of technology (WHO Technical Report Series, No. 961, 2011, Annex 7) should be considered, where applicable, when analytical method validation is organized and planned. 1.5 在组织和计划分析方法验证时，如适用，应考虑优良化验室规范和技术转移 指南（ WHO 技术报告第 961 号，2011 年附录 7）中所提供的建议。 2. General (revised):概述（修订过） o 2.6 The procedure should become part of a continuous verification procedure to demonstrate that it meets the predefined criteria over the life of the procedure. 2.6 程序应成为持续确认程序的一部分以证明其在程序的生命周期中符合既定 的标准。 o 2.7 Trend analysis and risk assessments should be considered at intervals to ensure that the method is appropriate