As the field of Advanced Therapy Medicinal Products (ATMPs) continues to evolve, regulatory expectations are increasingly shaped by established frameworks such as the International Council for Harmonization (ICH) guidelines and ATMP guidelines of the U.S. Food and Drug Administration (FDA), United States Pharmacopeia (USP), European Medicines Agency (EMA) and other relevant regulators. How QbD can be used within the regulatory framework, is layed out in an acrticle in the current GMP Journal issue.