A consortium including Pittsburghs Duquesne University has landed a federal contract to help FDA reviewers improve drug safety.
The consortium, the National Institute for Pharmaceutical Technology and Education Inc. (NIPTE), has signed a $652,000, two-year contract to develop and deliver a professional development program to help to ensure that FDA reviewers are current in state-of-the-art pharmaceutical manufacturing and technology.
Duquesne has already created some of the curricula for the program, says Alan Seadller, associate vice president for research at the university.
“We have developed real expertise in quality control,” he says. “The current way drugs are inspected is in a batch. If there’s a problem, you lose the whole batch. Theres no way to adjust ingredients. The new method includes Inspections and steps all the way along, involving equipment and machinery. Thats starting to move into industry.”
The inspection improvements, as well as an increase in the number of FDA drug inspectors, comes on the heels of well-publicized deficiencies in pharmaceutical materials imported from overseas.
Seadler says Duquesne has already hosted classes of inspectors for classroom-based training.
In the initial period, NIPTE will work with the FDA’s Office of Pharmaceutical Science on identifying the needs and developing recommendations on training areas. Once the assessment is complete, NIPTE will develop and deliver a scientific training program for the designated OPS staff.
Source: Alan Seadler, Duquesne University
Writer: Chris OToole