431431 Benefits of Quality By Design (QbD) for Consistent Product Quality

Monday, November 9, 2015: 3:15 PM
Ballroom B (Salt Palace Convention Center)
Jennifer Maguire, Office of Pharmaceutical Quality/Office of Process and Facilities, Food and Drug Administration, Silver Spring, MD

The pharmaceutical industry continues to embrace the principles outlined in ICH Q8(R2), Q9, Q10 and Q11 and to move from a Quality by Testing mentality to a Quality by Design paradigm. This talk will provide a high level overview of how the pharmaceutical industry can benefit by using QbD principles to develop robust manufacturing processes for small molecule drug products in order to consistently deliver quality drug products to the patient. Through examples, the talk will illustrate the QbD tools utilized by applicants during pharmaceutical development.  It will also touch upon Integrated Quality Assessment (IQA) in the newly formed Office of Process and Facilities within the Office of Pharmaceutical Quality.

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