The Focus on Quality Control

CorbisWhile it doesn't typically garner the lion's share of attention, quality control is just as important as other areas of science. If your R&D department comes up with the most promising compound of the century, without current Good Manufacturing Practices (cGMP) in place it may never get to patients. You need well-written procedures and properly maintained facilities and equipment, as well as quality assurance staff savvy enough to navigate the regulatory hurdles."Quality-control scient

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Corbis

While it doesn't typically garner the lion's share of attention, quality control is just as important as other areas of science. If your R&D department comes up with the most promising compound of the century, without current Good Manufacturing Practices (cGMP) in place it may never get to patients. You need well-written procedures and properly maintained facilities and equipment, as well as quality assurance staff savvy enough to navigate the regulatory hurdles.

"Quality-control scientist are the unsung heros, because they are not discovering new molecules," says Robert Bell, president and founder of Drug and Biotechnology Development, Clearwater, Fla. "They are testing to make sure that the company has a good product. Quality control is the thread that goes through everything they do."

It takes a blend of careful planning, hiring the right people, and meticulously following the Food and Drug Administration's (FDA) regulations to get through a pre-approval inspection, ...

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