Asian Journal Of Social Pharmacy

Abstract: Objective To study the history of international implementation of RTRT, and to extract the relevant experience for decision-makers in China. Methods Literature research and comparative research methods were used to analyze the opportunities and challenges faced by China’s implementation of real-time release testing combined with the history of real-time release testing in pharmaceutical enterprises abroad. Results and Conclusion Although there was technical support for China’s implementation of real-time release testing, the lack of corresponding regulatory documents and implementation guidelines made it hard to carry out. Real-time release testing can accelerate the production process of pharmaceutical products and save resources, but it is difficult to implement comprehensively in the field of pharmaceutical industry. Therefore, it is necessary to break down technical barriers. Accelerating the development of process analytical technology can also speed up the implementation of real-time release testing.

Key words: real-time release testing, batch release, parametric release, flexible regulation