Development and evaluation of an intelligent pharmaceutical manufacturing curriculum module under industry–education integration: a quasi-experimental study

The digital transformation of pharmaceutical manufacturing has generated an urgent need for graduates who possess competencies in intelligent manufacturing, data-driven process control, digital quality systems, regulatory compliance, and innovation-oriented problem solving. However, conventional pharmaceutical education often remains theory-centered and insufficiently connected with real industrial scenarios. This study developed and evaluated an Intelligent Pharmaceutical Manufacturing curriculum module under the framework of industry–education integration. The module incorporated Quality by Design (QbD), Process Analytical Technology (PAT), Manufacturing Execution Systems (MES), electronic batch records (EBR), digital twins, virtual simulation, AI-assisted process optimization, Good Manufacturing Practice (GMP) compliance, validation, and data integrity. A four-integration teaching model was proposed to connect curriculum content with industrial standards, classroom learning with production scenarios, physical practice with virtual simulation, and knowledge acquisition with innovation projects. A quasi-experimental pretest–posttest control group design was used to evaluate the module. Students in the intervention group received the newly developed curriculum module, whereas students in the control group received conventional instruction. Results showed that the intervention group achieved greater learning gains than the control group in knowledge acquisition, practical competency, digital manufacturing competency, and learning engagement. The largest improvement was observed in digital manufacturing competency, suggesting that the module effectively addressed a key limitation of traditional pharmaceutical manufacturing education. Qualitative feedback further indicated that students perceived the module as authentic, industry-relevant, and beneficial for future professional development. This study provides a transferable curriculum framework—centered on the proposed four-integration teaching model and industry–education co-cultivation mechanism—for cultivating pharmaceutical professionals capable of adapting to intelligent manufacturing, and offers practical implications for industry–education collaboration in higher education.