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。
Application of multivariate statistical process control techniques in pharmaceutical manufacturing process
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.
multivariate statistical process controlprincipal component analysiscontrol chartquality controldrug productiontraditional Chinese medicine
万方数据
维普
