PDA workshop on "Quality by Design for Biopharmaceuticals: Concepts and Implementation", May 21-22, 2007, Bethesda,...

Janet Woodcock, MD, Deputy Commissioner for Operations/Chief Medical Officer at FDA, closed the workshop. She stated that, "QbD represents an evolution and not a revolution" that is in response to the increasing cost pressures on both the regulatory agencies and industry to control the escalation of drug prices. She acknowledged that the successful implementation will require efforts and cooperation between industry and the FDA. She also said that the realization of the full benefits of implementing QbD will require changes in the way industry operates and in the regulations, and thus will take time. The issue of the lack of harmonization of these concepts across different regulatory agencies was recognized as a significant deterrent for companies to implement QbD. FDA is working with other major regulatory agencies to seek better alignment. The Agency also acknowledged that the concepts and associated flexibility of QbD has not yet reached the inspectional arena. The establishment of a "Pharmaceutical Inspectorate" that would standardize an approach and hopefully become an international organization was suggested as a potential outcome of the ongoing efforts.