Quid Pro Quo: FDA Pilot Program Needs Industry Support

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An MD&DI October 1998 Column

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In an effort to make FDA inspections more efficient, the agency is examining several different plans, including the Hazard Analysis of Critical Control Points (HACCP). An increasing number of manufacturers have expressed an interest in HACCP lately, but only Cyberonics (Houston) has gone ahead and implemented it as part of FDA's pilot program.

Steve Maschino and William Duffell, participants in Cyberonics' HACCP team and coauthors of "Can Inspection Times Be Reduced?: Developing a HACCP Plan" (page 64), hope more companies will implement HACCP to provide FDA with the additional evidence they think will convince the agency to adopt HACCP as permanent policy.

Cyberonics' pioneers in FDA's HACCP pilot program.

"We want others to know that HACCP is worth their time and attention," says Duffell. "It should be a carrot to strive for. Only companies with good compliance records will qualify for HACCP. It's a reward for good compliance behavior."

Maschino says that HACCP will allow for a shorter, better focused, more predictable inspection process. "Inspectors will spend time looking at what the manufacturer has defined as critical control points, and the company will be ready with supporting documentation. It removes the element of surprise in the inspection process."

HACCP is not a substitute for a comprehensive, full GMP investigation. These will probably continue to be conducted, although no one knows how often. But with fewer people, fewer dollars, and an increasing number of companies for FDA to cover, the agency needs an alternative that allows it to continue to perform its job, but in a more timely, economical fashion.

Duffell compliments Bruce Burlington, head of FDA's Center for Devices and Radiological Health, for encouraging manufacturers to become stakeholders in the implementation of the Modernization Act. "FDA is to be commended for thinking outside the box and finding ways to do more with less," he says. "But I'd like to see the industry set the trail. If we leave HACCP to FDA's creativity and imagination, the program may not come out the way we want it, or we might not get it at all."

Participating in the pilot program means volunteering to go through an inspection, albeit the new, three-day, user-friendly variety. According to Duffell, FDA assured the Cyberonics team that "the initial HACCP inspection would be without serious repercussions to participating organizations. The agency realizes that participating companies are trying to do it a favor. It's looking for a no-holds-barred relationship to try to implement the policy. It will be a learning tool to help establish what will be an even tighter protocol."

Duffell asserts that every company with a good compliance record should get involved in the pilot program. "With the FDA reassuring us about the inspections, there's no way you can screw it up," he asserts. "My CEO would have been all over my back for having FDA here on a voluntary basis if we didn't know we wouldn't have any trouble, particularly since we just went through a complete GMP inspection three months ago with zero observations."

A common misconception is that meeting HACCP requirements would be in addition to the quality system regulation; rather, it's a more focused protocol that involves only a part of the larger set of requirements. "It's not more work," insists Duffell. "It's just pulling together work that has already been done. Who says you have to do it all tomorrow?"

If the program is implemented, participating in HACCP could represent a valuable incentive for industry: the fact that a company is allowed to adopt a HACCP plan lets everyone know that a particular facility has an exemplary record with FDA.

Jennifer M. Sakurai is managing editor of MD&DI.

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