Advancing pharmaceutical quality oversight during the lifecycle of generic drug products

To meet the challenge of ensuring quality medicines to the American public and proactively prevent drug shortage situations, the Center for Drug Evaluation and Research has formed its newest super-office, the Office of Pharmaceutical Quality. This office integrates review of drug applications with the evaluation of manufacturing facilities for a more informed quality assessment. It also promotes a lifecycle approach to quality that integrates functional areas, data, and processes and provides a drug product knowledge base. This article describes the roles and responsibilities of Office of Pharmaceutical Quality during the quality assessment and lifecycle management of generic drug products.