基于QbD理念的药品质量分析研究新概念  

A new concept of drug quality surveillance based on quality by design

作　　者：金少鸿[1] 粟晓黎[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》2011年第10期1845-1849,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：本文阐述质量源于设计理念在药品质量评价分析中的应用基础,结合2010年全国评价性抽验的成效及特点,诠释质量源于设计理念在药品质量评价分析中的应用实践,展望质量源于设计理念在药品抽验工作计划、质量分析、质量再评价研究中的应用前景。The new approach-quality by design（QbD） was introduced into the national drug quality monitoring program in China.The essential concept,the scope and the application of QbD were explained and discussed by using the cases extracted from the 2010 national drug quality monitoring program.It is expected that the further application of QbD in national and local drug quality surveillance programs would greatly improve the output of the program,the ratio of costs and effectiveness.Meanwhile it will also raise the ability of the drug control institutes and the testing scientists.

关 键 词：药品抽验 质量分析 再评价 质量源于设计 

分 类 号：R917[医药卫生—药物分析学]