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,...


Communication is the cornerstone to an efficient if not speedy drug approval, Sietsema says. "If you don't communicate with the FDA, the chances that something is going to go wrong get to be very high." The government agency is more available to drug developers than ever before, says Judy Hanover, a research analyst with Life Science Insights, Framingham, Mass. "I think there has been a lot of recent changes and a willingness ... and an openness to communicate with the FDA, where they bulletproof your process."

While most FDA regulations are generally clear, not everything is laid out in black and white. For example, FDA documents called "Draft Guidance – Not for Implementation" often come out of advisory committee meetings. These reports give more detailed accounts about what the agency expects, but most drug developers aren't aware of the papers, let alone read them, according to Sietsema.

"Some of it is buried deeply," he says. "A regulatory person has probably attended the advisory meetings. That person probably knows the issues already, without having to dig through the transcripts." The FDA also has unwritten rules, Sietsema says. Again, the only way to keep track is by hiring good regulatory people in both your quality control and quality assurance departments who talk to people inside the agency. A company that ignores the FDA's recommendations does so at its own risk.


Quality-control and quality-assurance positions should be filled relatively early on, because such scientists are among your most important hires, Bell says. While quality-control scientists perform the necessary testing to ensure your product meets your specifications, your quality assurance team is responsible for making sure all procedures have been followed and documented appropriately. "Quality assurance is like the company's police force, making sure things are what they are supposed to be," says Bell.

Hiring someone who worked with the FDA recently is "very important because they know what help you can get and what help you can't get," says Hanover. You can hire the person on staff or as a consultant, she says, and one way to save money is to put a regulatory expert on the company's board.

The quality control scientists you recruit must also be trained on the instruments in your lab, according to Bell. With today's sophisticated technology, it's not enough for a scientist to have the right array of degrees; they also have to be trained to work with specific instruments, he says. "It's important to qualify chemists on the instrument[s] they are working on," says Bell. They need to perform calibrations and instrument validations that meet regulatory requirements. "Right now few universities are teaching students on FDA needs."

Attention to such details can be the difference between success and failure, says Bell. "A lot of companies only get one chance because that is all the funding they have," he says. "Most companies can't afford to go back and do it over again if they make a mistake."

Bob Calandra bcalandra@the-scientist.com

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