Self Inspection and its Potential Benefits Via ICH Q9--An Interview with Kevin O'Donnell, Ph.D., Irish Medicines Board.

Autor: Poska, Richard
Zdroj: Journal of Validation Technology (JVT); Spring2010, Vol. 16 Issue 2, p15-24, 10p
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.
Databáze: Complementary Index