title: FDA pharmaceutical quality oversight.
abstract: The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: lawrence.yu@fda.hhs.gov.
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D004345:Drug Industry / Q000592:standards*; D016568:Drugs, Generic / Q000592:standards*; D006801:Humans; D013678:Technology, Pharmaceutical / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D016568:Drugs, Generic
keywords: Facility investigations; Integrated quality assessment; Pharmaceutical quality; Pharmaceutical surveillance; Quality by design; Quality manufacturing systems