Implementing A Change Control Process In Pharma Manufacturing

By Anelis Aurand-Araos, Director of Scientific Affairs and Chief Compliance Officer, WellSpring

At WellSpring, as with any other pharmaceutical manufacturing company, we developed a change control policy to ensure that any proposed changes to product or processes were thoroughly examined before they were implemented, and that no unintended consequences would result. As we are currently reviewing and updating our policy, we felt that sharing our methodology would be illustrative of our process and instructive to others who need better processes.