Asian Journal Of Social Pharmacy

Objective To help China’s pharmaceutical enterprises better understand continuous manufacturing, and to promote the development of new technologies and innovation in the pharmaceutical industry. Methods The advantages and challenges of continuous manufacturing were summarized through literature research. Then, a comprehensive comparative analysis was conducted on the application of continuous manufacturing of approved and listed varieties by querying the evaluation documents of Europe, the USA, Japan, and China. Results and Conclusion The issues that Chinese pharmaceutical enterprises should pay attention to when applying continuous manufacturing technique were discussed from four aspects: feasibility analysis, variety selection, process research, and communication with regulatory authorities. Continuous manufacturing is an innovative technique that can change the production of the pharmaceutical industry. However, the uncertainty of new technique and the various changes brought about by continuous manufacturing models pose many challenges to its application. Implementing continuous manufacturing requires enterprises to have technological knowledge in quality management, research and development, and regulatory aspects. Enterprises should take advantage of the opportunity period before and after the emergence of new technique to seize the breakthrough of innovation so that continuous manufacturing can be better implemented in China.

continuous manufacturing, key factor, path research