FDA Opens Office of Pharmaceutical Quality

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-19-2015 21:28


The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) has launched a new office within CDER, the Office of Pharmaceutical Quality’s (OPQ), which creates a single unit dedicated to product quality. The new structure, which came into effect this month, January 2015, is designed to provide better alignment among all drug quality functions at CDER, including review, inspection, and research.

OPQ combines 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," according to information from the FDA. 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.

Changes include:
• Realignment of functions and personnel from the Office of Pharmaceutical Science to OPQ
• Realignment of preapproval and surveillance inspection activities from the Office of Compliance (OC) to OPQ
• Realignment of inspection-related activities for bioequivalence/bioavailability and non-clinical studies from OC’s Office of Scientific Investigations to the Office of Translational Sciences.

The OPQ is led Janet Woodcock, CDER Director and Acting Director of the OPQ and Lawrence Yu, Deputy Director of the OPQ. The other key members of the OPQ leadership team include:
• Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
• Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
• Office of Biotechnology Products (OBP): Director: Steve Kozlowski
• Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
• Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
• Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
• Office of Process and Facilities (OPF): Christine Moore (Acting)
• Office of Surveillance (OS): Theresa Mullin (Acting).

Source: FDA


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