David J. Goldfarb, Ph.D., Merck & Co., Inc., Rahway, NJ, USA
Assessing the robustness of a drug product formulation and manufacturing process to variations in raw material properties is an essential aspect of product development. Motivated by the need to demonstrate understanding of attribute-performance relationships at the time of product registration in addition to subsequent process maintenance, we reviewed existing approaches to raw material variations. Four of us at Merck & Co., Inc., Rahway, NJ, USA, Stephen L. Conway, Kenneth J. Rosenberg, Sutthilug “May” Sotthivirat, and I, collaborated on what was to be an internal white paper, but which has just been accepted for publication as a peer-reviewed Perspective Article in the Journal of Pharmaceutical Sciences.