GERPAC Special Interest Groups 3D Printing

The GERPAC 3D Printing Special Interest Group brings together European experts to promote the implementation of pharmaceutical 3D printing in hospital pharmacies and decentralized healthcare settings. This technology has the potential to enable personalized treatments, flexible dosing, tailored drug release profiles, polypills, reduced waste, and solutions to medicine shortages. As the field matures, discussions have moved from understanding its benefits to addressing practical challenges such as regulations, validation, quality control, costs, and pharmacopoeial standards. The group has already published a first scientific paper reviewing extrusion-based 3D printing technologies and their critical process parameters. Members are also contributing to EMA discussions on quality requirements for point-of-care manufacturing and to a Q&A document on the implementation of additive manufacturing for oral dosage forms.
A second paper is being developed to propose a quality framework covering equipment, software, formulation validation, quality control, and regulatory acceptance. Regulatory agencies and organizations such as EMA, EDQM, MHRA, ANSM, AFMPS, and MEB are increasingly involved in defining standards for 3D-printed medicines.
The group supports a risk-based regulatory approach ranging from magistral preparations for individual patients to industrial-scale manufacturing. Finally, the European 3DPace project aims to train future experts and advance research in pharmaceutical 3D printing through collaboration between academia, hospitals, industry, regulators, and patient organizations.