By Cindy H. Dubin, Contributor
Process quality, the manufacturing facility where the process occurs, and the supply chain that feeds into and out of that facility: these are the factors that determine the quality of a finished drug product. Add to this the complexity of today’s therapeutics, a global network of suppliers, and myriad regulations, and savvy life science organizations recognize they may need to make a seismic shift in how they manage quality control in the future.