Dong Ling, Sun Yu, Pei Wen-Xuan, Dai Jun-Dong, Wang Zi-Yu, Pan Meng, Chen Jiang-Peng, Wang Yun
Beijing University of Chinese Medicine, Beijing 102488, China.
Lanzhou Foci Pharmaceutical Co., Ltd., Lanzhou 730046, China.
Zhongguo Zhong Yao Za Zhi. 2017 Dec;42(23):4481-4487. 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-system integration" workflow. This article analyzed the correlation between the quality standards of all links, established standard operating procedures of each link and whole process, and constructed a high standard overall quality management system for TCM industry chains, in order to provide a demonstration for the establishment of TCM whole-process quality control system and provide systematic reference and basis for standardization strategy in TCM industry.
“质量源于设计”的理念表明，药品生产全生命周期的良好设计能够使药品满足预期的质量要求。针对中药行业存在的问题，本文在国际制造业质量控制理念的指导下，结合中药行业自身特点和发展现状，从国家战略层面提出了中药标准化体系。该战略的内涵是建立五个相互关联的体系：基于三指标体系的多指标体系、中药药材及饮片质量标准与规范体系、质量追溯体系、基于全过程质量控制的数据监测体系以及中药全过程质量管理体系，并通过“顶层设计-分步实施-系统集成”的工作流程，实现中药行业全过程的系统科学研究。本文分析了各环节质量标准之间的相关性，制定了各环节及全过程的标准操作规程，构建了高标准的中药产业链整体质量管理体系，旨在为中药全过程质量控制体系的建立提供示范，为中药行业标准化战略提供系统的参考和依据。
