In order to regulate the processing behavior of Chinese herbal medicines while freshly cut at the origin, control the quality of Chinese medicine from the source, promote the development of integrated processing and preparation of Chinese herbal medicines at the origin, and promote the high-quality development of the Chinese medicine industry, recently, the Guangxi Zhuang Autonomous Region Drug Administration issued the "Guangxi Zhuang Autonomous Region standardization of Chinese herbal medicines while freshly cut at the origin processing guidance (for trial implementation)" (hereinafter referred to as "guidance ").
The guidelines put forward four tasks, including the development of the origin of fresh-cut herbs species catalog, regulate the origin of fresh-cut processing behavior, regulate the procurement of fresh-cut herbs, and strengthen the quality management of fresh-cut herbs.
Guidance proposed, one of the following circumstances of Chinese herbal medicines, not included in the "species catalog": (1) the herbs of the original confusion, while fresh cut easily adulterated with counterfeit products; (2) while fresh cut has a negative impact on the quality (such as the main ingredients easy to volatile loss, etc.); (3) unfavorable storage, transportation; (4) is not yet able to achieve a larger scale or more standardized planting, breeding; (5) the existence of fresh cut while the risk is higher High and other circumstances that should not be included.
In the regulation of the origin while fresh cut processing behavior, the guidance proposed while fresh cut processing requirements of species, processing conditions, processes, quality standards, packaging and labeling, traceability system construction six tasks. Among them, in the process, the guidance proposed, Chinese medicine manufacturers should be developed in accordance with the varieties of origin while fresh cut processing process and technical requirements, and strict control of the process. Processes include only net selection, cleaning, cutting (slices, segments, blocks, flaps, etc.), drying, screening, packaging processes. Processing should refer to the "Good Manufacturing Practice" and its appendix for Chinese herbal drinks (hereinafter referred to as "GMP"), "Good Manufacturing Practice" (GAP) for Chinese herbal medicines, and should be complete and accurate batch production records.
In terms of packaging and labeling, the guidelines point out that fresh-cut herbs purchased by Chinese medicine manufacturers should have standardized packaging and labeling, and be accompanied by quality conformity markings. Its packaging materials in direct contact with the herbs should at least meet the food packaging material standards, labeling content should include: name, specifications, quantity, origin, harvest date, processing date, production batch number, storage, re-inspection period, processing units.
The "Guidance" emphasizes that Chinese medicine manufacturers should regulate the purchase and use of fresh-cut herbs, should be purchased from the origin of processing points with a sound quality management system, and signed procurement contracts and quality agreements; procurement, use of fresh-cut herbs should be consistent with the requirements of the fresh-cut system while processing varieties; fresh-cut herbs purchased to assume responsibility for quality management. At the same time, Chinese medicine manufacturers to strengthen the quality management of fresh-cut herbs, including strengthening the quality management of self-received and self-made, quality management of purchased fresh-cut herbs, quality management of the source of Chinese herbs.
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