WHO分析方法验证文件草案.docx

[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咨询洛施德GMP咨询微信号 Soltoris 功能介绍 洛施德GMP咨询旨在协助制药/医疗器械/食品企业提升GMP质量管理体系，通过国内外GMP认证，并透过实施我司自主研发的《SISQP全面质量管理系统》，实现合规-高效-可控的信息化质量管理体系。若您有任何需求，欢迎联系我们获取更多的信息。 WHO Draft on Analytical Method ValidationWHO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）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）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。2.7 Trend analysis and risk assessments should be considered at intervals to ensure that the method is appropriate for its intended application.2.7?趋势分析和风险评估应定期考虑，以确保分析方法适合其既定用途。2.8 Changes to methods should be managed in accordance?with the authorized chang