FDA Forwards Renewed Quality Agenda at ISPE’s Annual Meeting BY STEVE KUEHN, EDITOR-IN-CHIEF NOV 05, 2013

Janet Woodcock, director the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) opened the International Society of Pharmaceutical Engineer’s (ISPE) Annual Meeting in Washington D.C. with the regulator’s current agenda: “Another push to modernize the regulation of pharmaceutical quality.” According to Woodcock, Industry and the FDA have made great progress since the introduction of its Pharmaceutical Quality for the 21st Century more than a decade ago.

Citing the advent of the risk-based approach to drug quality and safety, Woodcock says “much had come of it,” speaking about the initiative and how it has modernized both the pharmaceutical manufacturing industry and the regulatory body over the ensuing years and that it’s been successful in many ways. From her perspective, the first initiative institutionalized the use of process analytical technologies and ushered in the modern era of quality management. This, she says, was given a boost by the introduction and adoption of the Quality by Design. According to Woodcock “then we introduced the concept of Quality by Design, with its emphasis on design and process and product knowledge, and I think that’s been very successful as well.”

 http://www.pharmamanufacturing.com/articles/2013/fda-quality-agenda-at-ispe/