分析方法确认内容介绍  

Analytical method verification in China OMCLs

作　　者：许明哲[1] 黄宝斌 杨青云[1] 田学波[1] 白东亭[1] 王佑春[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2015年第1期183-189,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：方法确认是药品检验机构在采用药典方法或者法定方法进行检验时必不可少的一个环节。通过合适的方法确认,证明检验人员有能力操作药典方法或法定方法以及证明方法对品种的适用性。目前国内各药品检验所对方法确认的理解不同,做法也不一致。本文根据我国药品检验实际工作内容,结合国际最新指导原则,阐述了药品检验方法确认的概念,给出了药检工作中最常使用的三类检测方法确认需要进行的具体内容,为日常检验工作提供指导。Analytical method verification is an essential procedure when we employ the compendial or standard method for the quality control of medicines. By performing analytical method verification,the suitability of compendail methods is demonstrated and meanwhile the capability of analysts to successful operate the method is assured.Currently there exists various misunderstandings regarding analytical method verification among China Official Medicine Control Laboratories（ OMCLs）. This paper elaborates the concept of analytical method verification based on the guidelines available and the daily work of China OMCLs,and more importantly,defines the activities that are required to fulfill method verification for the three most commonly used categories of chemical test methods,eventually to provide a practical guidance for medicine quality control work in China OMCLs.

关 键 词：药品检验所 分析方法确认 分析方法验证 药典分析方法 指导原则 

分 类 号：R917[医药卫生—药物分析学]