分析方法验证国内外技术指南现状分析

Analysis of the current situation of domestic and foreign guidelines for method validation

分析方法验证是保证检测方法准确可靠的重要步骤,对确保产品质量稳定可靠不可或缺。各国药典和相关组织很早就开始研究和规范方法验证的内容,并随着科技的进步,不断地完善。本文对分析方法验证的主要技术指南进行概述和分析,为读者更好地了解各国对药品分析方法验证指南的修订历程与要求提供参考。

Method validation is an important step for ensuring the accuracy and reliability of a testing method and then for guaranteeing the quality of a product. The pharmacopoeias in various countries and relevant organizations had already studied and standardized the contents of method validation for long time,and have continuously improved the contents with the progress of science and technology. In this paper,the main guidelines were summarized and analyzed about the validation of analytical procedure and it is helpful for readers to better understand the revision process and requirements of the guidelines in various countries.