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.
