FDA is continuing to refine its quality-by-design (QbD ) review framework by creating QbD “CMC lead” and “liaison” positions within the Office of New Drug Quality Assessment (ONDQA), instituting an internal database of QbD application elements for use by reviewers, and increasing collaborative research between ONDQA and academia on QbD-focused topics.
Additional support of ONDQA’s review efforts is being provided by the implementation of a quality management system (QMS), which is well under way, with the first audit of the system taking place in November, 2011.
ONDQA Acting Director Christine Moore told attendees at the ISPE Annual Meeting in Dallas, Texas, in early November that her office has been “working very actively” for about the last year and a half on implementation of a QMS. “We have foundations in place – for example, the first SOP that you write on how to write an SOP.”
Moore provided updates on her office’s efforts to: ● meet the challenges of applying risk assignment-based review approaches to new drug applications ● advance its internal QMS ● improve the review of QbD applications, and ● collaborate with academics to advance the science related to manufacturing and product quality.