Friday, April 17, 2015

About the FDA's Office of Pharmaceutical Quality (OPQ) - FDA.gov

Read the full article: About the Center for Drug Evaluation and Research > Office of Pharmaceutical Quality - FDA.gov:


"What OPQ Does

OPQ is a new office within CDER that creates a single unit dedicated to product quality. The new structure, to be stood-up in January 2015, is expected to provide better alignment among all drug quality functions at CDER, including review, inspection, and research.

OPQ will combine non-enforcement-related drug quality work into one super-office, creating one quality voice and improving our oversight of quality throughout the lifecycle of a drug product. OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas – new drugs, generic drugs, and over-the-counter drugs."

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