Quality Control and Regulatory Landscape of 3D-Printed Drug Products

This chapter provides an overview of the evolving landscape concerning the quality control (QC) and regulatory considerations surrounding 3D-printed drug products. With the advent of 3D printing in pharmaceutical manufacturing, the ability to create intricate dosage forms and personalized medications has introduced new opportunities and challenges. Effective QC strategies encompass material selection, process validation, and post-processing steps to ensure both product integrity and patient safety. The regulatory framework for 3D-printed drug products is rapidly developing, necessitating a cohesive approach to address technological complexities and ensure compliance. This chapter highlights the need for standardized methodologies, collaboration between stakeholders, and proactive regulatory engagement to fully exploit 3D printing’s potential in drug product innovation while upholding quality and regulatory standards.