多变量统计过程控制技术在药品生产过程中的应用  

Application of multivariate statistical process control techniques in pharmaceutical manufacturing process

作　　者：朱雨婷 韩子卫 韩鹏 刘雪松[1] 徐昕怡 陈勇[1] ZHU Yuting;HAN Ziwei;HAN Peng;LIU Xuesong;XU Xinyi;CHEN Yong(College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]浙江大学药学院,杭州310058 [2]国家药典委员会,北京100061

出　　处：《中国药品标准》2024年第3期227-233,共7页Drug Standards of China

基　　金：2022年度国家药品标准制修订研究课题(2022Y08)。

摘　　要：介绍了多变量统计过程控制(multivariate statistical process control,MSPC)的基本概念和有关背景。描述了MSPC实施的基本流程以及常用统计量与控制图。强调了MSPC在药品生产过程中的重要作用,特别是中药领域,为药品生产过程质量控制方法的选择提供参考。总结了MSPC的优势和不足,并展望了MSPC在药品生产和质量控制方面的发展趋势。The basic concept and related background of multivariate statistical process control(MSPC)were introduced.The basic process of MSPC implementation and the common statistics and control charts were described.The important role of MSPC in the pharmaceutical production process was emphasized,especially in the field of traditional Chinese medicine,providing reference for the selection of quality control methods in drug production process.The advantages and disadvantages of MSPC were summarized,and the development trend of MSPC in drug production and quality control was prospected.

关 键 词：多变量统计过程控制 主成分分析 控制图 质量控制 药品生产 中药 

分 类 号：R921.2[医药卫生—药学]