中草药健康产业新品开发HACCP管理系统探讨

Study on Establishing HACCP Management System for New Product Development in Chinese Herbal Health Industry

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 analyzing the principle and development history of QbD and summarizing what we have learned from QbD, we analyzed the possible deviations in the current practice of HACCP and recommended improvement countermeasures. After initiating the importance and possibility of establishing HACCP management system for new product development in Chinese herbal health industry by moving forward HACCP management from manufacturing to design process and the principles and methods of how to refer to and learn from QbD, we put forward a practical model of HACCP management system for new product development in Chinese herbal health industry. The results show that establishing HACCP management system for new product development in Chinese herbal health industry is feasible and practical.