FDA pharmaceutical quality oversight

Lawrence X. Yu

doi:10.1016/j.ijpharm.2015.05.066

FDA pharmaceutical quality oversight

2015-08-01

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DOI：10.1016/j.ijpharm.2015.05.066

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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. Published by Elsevier B.V.

Keyword:

Pharmaceutical quality

Quality by design

Quality manufacturing systems

Integrated quality assessment

Facility investigations

Pharmaceutical surveillance

FDA pharmaceutical quality oversight

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