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FDA awards contract for QbD research

By Nick Taylor, 03-Nov-2008

Related topics: Materials & Formulation

The FDA has awarded a $1.19m contract for the development of quality by design (QbD) guidance for pharmaceutical manufacturers.

Under the contract the National Institute for Pharmaceutical Technology and Education (NIPTE) will develop design specifications.

NIPTE is a nonprofit consortium of 11 pharmaceutical engineering universities, including Purdue that will receive $300,000 to utilise its expertise in pharmacy, engineering and biological sciences to develop guidance.

Alan Rebar, senior associate vice president for research at Purdue, said: "With this FDA funding, Purdue will collaborate with other strong universities to develop this emerging area where we can focus on improving the science of drug development itself.

"This team also will study how to make the drug-manufacturing process more modern, helping improve efficiencies and the effectiveness of the pharmaceutical industry."

Research by the consortium will start this year and is predicted to finish in September 2010, after which the information gained will be made public.

By the end of the contract the US Food and Drug Administration (FDA) is hoping to have furthered development its QbD initiative, which aims to take a more scientific approach to pharmaceutical development and manufacture.

In particular the contract is intended to enhance quality control, improve manufacturing efficiency and provide more front-end quality so the system is less reliant on back-end inspections.

To achieve this the researchers are looking at manufacturing operations including blending, granulation and drying. This information will then be related to scale-up and stability.

NIPTE was created specifically to work with the FDA and industry to improve the development and manufacture of pharmaceuticals.