Application of multivariate statistical process control techniques in pharmaceutical manufacturing process
朱雨婷 1韩子卫 1韩鹏 1刘雪松 1徐昕怡 2陈勇1
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作者信息
1. 浙江大学药学院,杭州 310058
2. 国家药典委员会,北京 100061
折叠
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.
Abstract
The basic concept and related background of multivariate statistical process control(MSPC)were intro-duced.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 tra-ditional 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
Key words
multivariate statistical process control/principal component analysis/control chart/quality control/drug production/traditional Chinese medicine
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