Abstract: The quality control during the manufacturing process of traditional Chinese medicine (TCM) is paramount to ensuring the quality of the final product. However, the sheer diversity of TCM ingredients and the intricacies of the production process pose significant challenges to achieving precise quality control. The review introduced an intelligent control concept centered on functional substances in TCM quality, which comprehensively explained the scientific essence of TCM quality, and provided a theoretical foundation for determining "what to control" and "how to control" within the complex system of TCM components. Furthermore, through the advanced informatization, digitization, and intelligent technologies, our team has conducted extensive research and construction practices on the intelligent transformation and digital upgrade of traditional Chinese medicine (TCM) manufacturing processes. Ultimately, the establishment of a quality control system tailored specifically for TCM manufacturing with functional substances serving as the primary quality target, which presented an opportunity to solve the difficult problem of process quality control in TCM manufacturing.