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通过对质量源于设计(QbD)原理及其发展过程的分析,总结了QbD对建立中草药健康产业新品开发危害分析和关键控制点(HACCP)管理系统的启示,分析了现行HACCP实践中可能存在的偏差,提出了针对这些偏差的改善措施建议,在此基础上总结了中草药健康产业HACCP管理前移的重要性和可能性以及借鉴和学习QbD原理的方法和原则,最终提出了中草药健康产业新品开发HACCP管理的实例模型。结果表明,运用QbD原理建立中草药健康产业新品开发HACCP管理系统是可行的。
Through the analysis of the QbD principle and its development process, this paper summarizes the implications of QbD for building a new product development hazard analysis and critical control point (HACCP) management system for herbal health industry, and analyzes the possible existing problems in HACCP practice Deviation, put forward suggestions for improvement measures for these deviations, and on this basis summed up the importance and possibility of HACCP management advancement of Chinese herbal medicine health industry as well as the methods and principles of drawing lessons from QbD principle and finally proposed the development of Chinese herbal medicine health industry new products HACCP managed instance model. The results show that it is feasible to establish HACCP management system based on QbD principle and new product of Chinese herbal medicine health industry.