分析方法验证、转移和确认概念解析

分析方法验证、转移和确认的目的是证明分析方法的适用性,对保证检测结果的一致性、可靠性和准确性具有重要作用.方法验证、转移和确认的概念不同,适用范围不同,在实际工作中存在一些模糊概念,而且也存在使用不当的情况.鉴于上述情况,本文详细阐述药品方法验证、方法转移、方法确认的联系、区别、适用范围,为药品检验检验相关工作提供参考.

The aim of analytical method validation,transfer and verification is to confirm that the analytical method fits for the intended purpose.Method validation,transfer and verification are very important to ensure the quality,reliability and consistency of analytical results,which is an integral part of any good analytical practice.However,there are lots of confusion and misunderstanding on concepts and application scopes of method validation,transfer and verification in practical works.This paper elaborates the correlation,differences and application scopes of method validation,transfer and verification,so as to provide a reference for the relative work of drug quality control.

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