Discussion on research thinking of traditional Chinese medicine standardization system based on whole process quality control

• Published in: Zhongguo zhongyao zazhi Vol. 42; no. 23; p. 4481
• Main Authors: Dong, Ling, Sun, Yu, Pei, Wen-Xuan, Dai, Jun-Dong, Wang, Zi-Yu, Pan, Meng, Chen, Jiang-Peng, Wang, Yun
• Format: Journal Article
• Language: Chinese
• Published: China 01.12.2017
• Subjects: Drugs, Chinese Herbal - standards; Medicine, Chinese Traditional - standards; Quality Control; standardization strategy in traditional Chinese medicine; whole-process quality control; quality tree; tri-indicators system
• ISSN: 1001-5302
• DOI: 10.19540/j.cnki.cjcmm.20171113.005

The concept of "Quality by design" indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry, the TCM standardization system was put forward in this paper from the national strategic level, under the guidance by the idea of quality control in international manufacturing industry and with considerations of TCM industry's own characteristics and development status. The connotation of this strategy was to establish five interrelated systems: multi-indicators system based on tri-indicators system, quality standard and specification system of TCM herbal materials and decoction pieces, quality traceability system, data monitoring system based on whole-process quality control, and whole-process quality management system of TCM, and achieve the whole process systematic and scientific study in TCM industry through "top-level design-implement in steps-syst