470944 The Integrated Quality Assessment:  Office of Process and Facilities' Perspective on the Holistic Evaluation of Pharmaceutical Quality

Monday, November 14, 2016: 10:00 AM
Continental 5 (Hilton San Francisco Union Square)
David Doleski, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD

The Office of Pharmaceutical Quality (OPQ) was formed for the purpose of ensuring a consistent and unified approach to FDA’s assessment of pharmaceutical quality for pharmaceutical products. This restructuring involved a dramatic modification in the structure of the organization, changes in roles and responsibilities for review and inspection functions, and an elevated stature for the quality assessment function within CDER. The reorganization and resulting formation of OPQ has been in effect since January 2015. Since that time there has been continued implementation and improvement upon the integrated quality assessment within OPQ. This assessment now includes a greater level of communication and interdependency within the assessment team, simultaneous with the specialization of the assessment disciplines for products, processes and facilities. In particular, there has been an evolution of the facility assessment: from the initial risk-based for the assessment of the facility; to the composition of the inspection team and focus of the pre-approval inspection; concluding with the final integration of the inspection results into the quality assessment. The changes have positioned OPQ to provide most appropriate level of engagement with sponsors and the development of expertise necessary to perform the technical assessment of increasingly complex technologies, such as continuous manufacturing of pharmaceutical products. The basis for the changes with OPQ will be provided, along with a description of important initiatives within the office, concluding with a description of the programmatic successes resulting from the formation of OPQ.

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