The OrganaBio cGMP Manufacturing Facility (Miami, FL) – Manufacturing with Clinical Translation in Mind

Current good manufacturing practice (cGMP) is a set of regulations instituted and enforced by the U.S. Food and Drug Administration (FDA) that “assure proper design, monitoring, and control of manufacturing facilities and establish minimum requirements for any manufacturing process.” When a company is following cGMP standards it assures “identity, strength, potency, and purity of drug […]