NIPTE to study scale-up design spaces and parenteral QbD

FDA has awarded two contracts to the National Institute for Pharmaceutical Technology and Education for quality-by-design studies. Under a $1.2 million contract, NIPTE will develop models and methodologies for establishing design spaces that could allow commercial scale-up of three types of unit operations without prior approval from FDA. Under a smaller contract, scientists with universities represented by the non-profit organization will work with counterparts at Baxter, Pfizer and FDA to develop case studies that should help establish a common understanding of QbD for common parenteral manufacturing processes. Both contracts will support guidance development by the Office of Pharmaceutical Sciences in FDA's Center for Drug Evaluation and Research (see "The Gold Sheet," September 2008, pp. 4-5)