FDA Awards NIPTE $1.19 Million Contract to Help Develop QbD Guidance

The US Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE, West Lafayette, IN) a contract to develop the science behind Quality by Design (QbD) and design space specifications. The contract is intended to aid in developing specifications that allow for the implementation of the QbD framework to improve product quality through science and technology.

Prabir Basu, PhD, executive director of NIPTE, said that one of the difficulties faced by pharmaceutical manufacturers in developing their design spaces is the issue of scalability. “The only way one can have scalable design space is if they can develop knowledge of first principles,” he said. NIPTE’s goal is to use experimental data to create models and develop some first principle design spaces that are scale independent. Basu said his organization would also study the effect of scale up on stability. “This is one of the issues the FDA is concerned about, and they want some science to be developed around it,” he said.

The results of NIPTE’s 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. This research will begin this year and is expected be ongoing through September of 2010.