The FDA has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE) a contract to develop Quality by Design guidance on design space specifications.
The intention of this award is development of specifications allowing for the implementation of Quality by Design (QbD) framework to improve product quality through science and technology. QbD is aligned with the Center for Drug Evaluation and Research's Critical Path Initiative and Moving Manufacturing into the 21st Century to develop new manufacturing approaches that improve pharmaceutical manufacturers' ability to assess and improve product quality.
"This brings a greater degree of science into the pharmaceutical manufacturing process; bringing in more front-end quality and less dependence on back-end inspections," said Prabir Basu, Executive Director of NIPTE. "The framework developed through this research will be tested on a specific drug product."
The results of this study will potentially serve as the basis for formulating best practices and developing science based guidance documents that can be used by the FDA to evaluate new and generic drug applications. By strengthening the science-based technology through the QbD initiative, FDA is continuing to improve its regulation of new medical products by using the best management approaches, the best information technology, and the best quality systems and review processes.
This research will begin this year and is expected be ongoing through September of 2010.
The National Institute of Pharmaceutical Technology and Education (NIPTE) is an independent, non-profit organization representing 11 U.S. universities that are leaders in pharmaceutical science and engineering. The member universities are Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kansas, University of Kentucky, University of Maryland - Baltimore, and the University of Minnesota.