Current Good Manufacturing Practice (cGMP) outlines strict guidelines for producing safe, effective, and high-quality biopharmaceuticals. It regulates processes, facilities, equipment, and personnel to ensure consistency, minimize risks, and meet global regulatory requirements—supporting the delivery of reliable therapies to patients worldwide. https://medium.com/@xelleratherapeutics/the-role-of-cgmp-in-regulatory-approval-processes-d0fd8159200a