Management system and development strategy of quality Chinese medicine.
10.19540/j.cnki.cjcmm.20210713.601
- Author:
Lin-Lin DONG
1
;
Yong-Gang DUAN
2
;
Bo WANG
3
;
Chao-Qun WANG
1
;
Guang-Fei WEI
1
;
Yi LIU
1
;
Zhong-Zhi QIAN
4
;
Shi-Lin CHEN
1
Author Information
1. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
2. China Association for Quality Beijing 100048, China.
3. Hubei Institute for Drug Control Wuhan 430075, China.
4. Chinese Pharmacopoeia Commission Beijing 100061, China.
- Publication Type:Journal Article
- Keywords:
management system;
production process management;
quality Chinese medicine;
quality inspection and certification management;
six sigma(6σ) management;
standard management;
traceability management
- MeSH:
Drugs, Chinese Herbal;
Food;
Medicine, Chinese Traditional;
Quality Control;
Reference Standards
- From:
China Journal of Chinese Materia Medica
2021;46(17):4307-4313
- CountryChina
- Language:Chinese
-
Abstract:
The development of quality Chinese medicine is an important way to improve the quality of Chinese medicine, and ensure the safety and effectiveness of Chinese medicine. This article systematically elaborates the definition, classification, standard and mana-gement certification strategy of quality Chinese medicine. We present the quality Chinese medicine which is higher quality than that of eligible Chinese medicine based on quality control standards. Quality Chinese medicine is strictly in accordance with management procedures, likely GAP and GMP et al, during the productive process, which quality indicators is higher than that of the current relevant national quality standards, such as Chinese Pharmacopoeia(ChP) et al; its limited indicators such as exogenous pollutants and endogenous toxic substances are lower than that of the current relevant national quality standards, likely ChP et al; meanwhile these Chinese herbal medicine, medicinal pieces, patent medicines, and health products and foods with Chinese medicine raw materials are been certificated by quality Chinese medicine. At the same time, this article systematically expounds the five major management systems of quality Chinese medicine, including technical training management for practitioners, productive process management, standard mana-gement, quality inspection and certification management, and product traceability management. And we put forward strategies to improve the supervision and management system, and promote the standardization and development of quality Chinese medicine by improving the technical management system of quality Chinese medicine, strengthening the quality management system and six sigma(6σ) management in the company. These strategies will provide a reliable basis and effective way to improve the quality of Chinese medicine.
