Quality control strategy of traditional Chinese medicine based on pharmaceutical product lifecycle management.
10.19540/j.cnki.cjcmm.20221129.601
- Author:
Tian-Jiao ZHENG
1
;
Wei HAN
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration Beijing 100022, China.
- Publication Type:Journal Article
- Keywords:
"holistic view" and "phased";
pharmaceutical product lifecycle management;
quality control strategy;
quality risk management;
whole process quality control
- MeSH:
Medicine, Chinese Traditional;
Drugs, Chinese Herbal/therapeutic use*;
Quality Control
- From:
China Journal of Chinese Materia Medica
2023;48(5):1407-1412
- CountryChina
- Language:Chinese
-
Abstract:
Quality control is pivotal in the research and development of traditional Chinese medicine, whose connotation is not limi-ted to the qualitative or quantitative detection of an indicator component, but extends to the establishment of a whole process quality control system from the perspective of pharmaceutical product lifecycle management. This study discussed the quality control strategy of Chinese medicine based on the concept of pharmaceutical product lifecycle management, and proposed the following suggestions:(1) to focus on the "holistic view" and "phased" characteristics of quality control and strengthen the establishment of quality control strategy based on top-level design;(2) to strengthen the research on quality control of Chinese medicine based on quality risk management, focus on the correlations of quality control indicators with the safety and effectiveness of traditional Chinese medicine, and establish a quality evaluation system consistent with the characteristics of traditional Chinese medicine;(3) to consider the characteristics of different registration classifications in the establishment of quality control strategy;(4) to highlight the quality correlation research, strengthen the quality transfer research, ensure the quality traceability, and establish a sound quality management system;(5) to strengthen the quality research on marketed drugs to achieve dynamic quality improvement.
