Incidents such as McNeil Consumer Healthcare’s (New Brunswick, NJ) May 2010 recall of over-the-counter children’s and infants’ liquid products remind patients and drugmakers alike that they cannot take high product quality as a given. Greater process monitoring and control could help reduce manufacturers’ chances of creating out-of-specification dosage forms. Maintaining a constant state of control is essential to staying in the good graces of the US Food and Drug Administration. Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands.