EBE Concept Paper - Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products and ATMPs
Brussels, 17 December 2018 Effective management and control of raw materials (RM) used in the manufacture of biological medicinal products including advanced therapy medicinal products (ATMPs) requires an appropriate framework to identify and focus on critical aspects that must be addressed from a quality, regulatory and business perspectives. There are currently no written industry guidelines available