FDA Forwards Renewed Quality Agenda at ISPE’s Annual Meeting

By Steve Kuehn, Editor-in-Chief

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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.”

Woodcock’s appraisal of QbD is that it has proven to be a sharp tool to improve drug quality and help the industry trim costs. “The adoption of QbD, as an approach as reported by the industry itself,” says Woodcock, “has been a very successful strategy. The use of QbD techniques result in much better transfer between development and commercial manufacturing, a very smooth transfer,“ abating what she characterizes as the “throw it over the wall,” strategy that as she put it, forces the commercial production side of pharma to “just make it.” She says that QbD has produced dramatic reduction of defect and deviation rates in commercial production “once QbD has been established.”

Woodcock describes that in effect, QbD has worked to be an effective cost containment mechanism that has decreased cost and improved quality for those firms that have adopted its practices thoroughly. Woodcock says that QbD submissions from firms have shown that companies have learned a lot (as have the FDA), but that success has been mixed at best in giving the industry freedom to operate. She finds that in spite of all the “goodness” from the initiative, some of its fundamental objectives have not yet been realized, hence the renewed push for quality in the wake of Pharmaceutical Quality for the 21st Century. But ultimately, Woodcock says, both the industry and the FDA need to better establish quality benchmarks and best practices. The FDA recognizes that it needs to offer industry something more actionable and concrete, but at the end of the day, the industry needs to continue to focus on incentivizing its own culture of quality: “The industry has to deliver quality, seeking dedication to quality from the shop floor to the executive suite.”

 

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