Abstract: Quality by Design（QbD） is a new concept for achieving product quality control, and it plays an important guiding role in the design of drug synthesis routes and process optimization.Currently, there is no report on integrating the QbD concept into the teaching practice of drug synthesis process courses.The teaching team demonstrates the guiding role of the QbD concept in the synthesis route design and process optimization of active pharmaceutical ingredients（APIs） through concrete examples, following the evolution of quality control from “end product inspection, production process control, to product design/research stage control”.Additionally, using Problem-Based Learning（PBL）,students gain a deep understanding of the practical significance of QbD in ensuring the production stability and quality of pharmaceuticals.This approach stimulates students’ innovation and teamwork spirit and provides valuable experience for cultivating master’s degree students in pharmacy.