Abstrakt: |
An interview with Kevin O'Donnell, Market Compliance Manager and Senior good manufacturing practice (GMP) Inspector at the Irish Medicines Board in Dublin, Ireland, is presented. He says that if he must choose one area within the European Union (EU) GMP environment that warrants immediate attention, it would be self inspection. He talks about the main factors that have contributed to inadequate self-inspection programs. He states the benefits that an increased and more transparent focus on self inspection will give companies. |