7 - 3D Printing in Pharma: Regulatory and Compliance Expectations in the Digital Age

This presentation explores how 3D printing is transforming pharmaceutical manufacturing and how the FDA is adapting its regulatory and compliance frameworks to support this innovation. It reviews FDA programs like the Emerging Technology Program and the Advanced Manufacturing Technologies Designation Program, and outlines the agency’s expectations for the novel digital, AI enabled manufacturing around digital file control, batch definition, AI model validation, and real-time monitoring. Case studies of ZipDose® and Triastek’s MED® 3D printing platform illustrate how innovators have successfully navigated regulatory pathways using 3D printing, digital twins, and AI. The talk concludes with key FDA concerns and takeaways for manufacturers looking to adopt 3D printing in a compliant and innovative way.