Application of multivariate statistical process control techniques in pharmaceutical manufacturing process
10.19778/j.chp.2024.03.003
- VernacularTitle:多变量统计过程控制技术在药品生产过程中的应用
- Author:
Yuting ZHU
1
;
Ziwei HAN
;
Peng HAN
;
Xuesong LIU
;
Xinyi XU
;
Yong CHEN
Author Information
1. 浙江大学药学院,杭州 310058
- Keywords:
multivariate statistical process control;
principal component analysis;
control chart;
quality control;
drug production;
traditional Chinese medicine
- From:
Drug Standards of China
2024;25(3):227-233
- CountryChina
- Language:Chinese
-
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.