The global use of TCM has been steadily increasing,yet Chinese TCM products still face significant challenges in entering international markets,including cultural differences between East and West,inadequate quality standards for TCM,regulatory barriers against herbal medicines,and the substandard quality of medicinal materials.The 2022 edition of Chinese Herbal Medicine Production Quality Management Code introduced the concept of Hazard Analysis and Critical Control Points(HACCP)to control the harmful factors in the production of Chinese herbal medicine;at the same time,the international standard of TCM was established after the establishment of ISO/TC249 to control the quality of TCM from the source by carrying out GAP and ISO double certification,which is the fundamental way for Chinese TCM to expand its international market share.This study conducted a comparative analysis of the application status of three key systems—GAP(Good Agricultural Practices),HACCP and ISO(International Organization for Standardization)—in the quality control of TCM.Based on this analysis,this article proposed that China's TCM production standards should draw upon the strengths of these international quality management systems to reduce production risks and costs while enhancing the practicality and implementation of GAP guidelines.
关键词
中药材/GAP体系/HACCP体系/ISO体系/质量控制
Key words
TCM/GAP system/HACCP system/ISO system/quality control
维普
万方数据