Abstract:Under the framework of pharmaceutical quality by design (QbD), a process control strategy is defined as a combination of a set of planning control methods and procedures used to ensure product quality and process performance which meets expected goals. The advanced process control strategy depends on the understanding of pharmaceutical processes and the accumulation of relevant knowledge. At present, the control of the domestic pharmaceutical process is experiencing a shift from the quality by testing (QbT) mode to the QbD mode. This paper summarizes and compares the hierarchy models of process control strategy proposed by Lawrance Yu of the U.S. FDA and the PQLI working group of the International Society of Pharmaceutical Engineering. Advanced process control methods, such as realtime release testing of drug product quality, process design space, feedforward control and feedback process control, closed-loopprocess control and intelligent process control, as well as their applications in Chinese medicine and pharmaceutical production were reviewed.