The Mode of the Transformation of Intelligent Manufacturing in Chinese Medicine Industry and the Discussions on Regulatory Concerns
The improvement of quality control level of Chinese medicine(CM)industry demands the guide of innovation in science and technologies,and the support of advanced pharmaceutical manufacturing engineering technologies.Intelligent manufacturing which integrates advanced manufacturing technologies and information technologies,has become the advanced manufacturing made to increase the quality and efficiency of manufacturing industry.Focusing on the major strategic project of intelligent manufacturing implemented in CM industry,this study proposed the transformation directions of developing intelligent manufacturing in CM industry,which were based on the characteristics of CM product quality and manufacturing process,as well as the problems of quality management and control faced by CM industry and the advantages of intelligent manufacturing technologies.Four directions were proposed,including the transformation from experience-based control to data-driven control,the transformation from product-test mode to process control and management mode,the transformation from separation to integration,and the transformation from drug product manufacturing to the full life cycle ser-vice of drug product.The achievements and industrial application of intelligent manufacturing by representative CM enterprise were intro-duced,and the regulatory concerns generated from the intelligent manufacturing transformation of CM industrial were discussed.This paper provides reference for CM industry to plan systematic architecture and design technical chart when developing intelligent manufac-turing projects.
Chinese medicine industryIntelligent manufacturingRegulatory scienceAdvanced pharmaceutical manufacturing technology
万方数据
维普
