FDA Wants You in Control

FDA has thrown a lot your way lately. Bar code rules, RFID use for anticounterfeiting, and new electronic labeling requirements are just a few of the recent edicts to come out of the agency. As inundated as you must feel, don’t worry—FDA is not trying to micro-manage you. In fact, the agency may begin managing you a bit less.

Sound too good to be true? It is all part of FDA’s risk-based approach to regulation. During the opening address at Interphex 2004 in March, FDA deputy commissioner Janet Woodcock reported progress toward the agency’s initiative, “Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach.” Part of that risk-based approach is the use of emerging science to maintain product quality.

FDA knows that you know science better than it does. “We want to make sure that up-to-date science is incorporated in regulations,” Woodcock explained. “Manufacturers are much more advanced in quality systems than we are. We are looking at how GMPs stack up against modern quality systems.” (For more on Woodcock’s speech, see the news story on page 12.)

FDA’s latest feat in its initiative is its policy guide, “Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval,” released in March. It replaces “Process Validation Requirements for Drug Products Subject to Pre-Market Approval.” This new policy will guide agency staff during compliance decisions.

The agency’s Web site says that the new guide recognizes “the role of emerging advanced engineering principles and control technologies in ensuring batch quality. For drugs produced using these new principles and technologies, this [guide] provides for possible exceptions to the need for manufacturing multiple conformance batches prior to initial marketing.” In other words, manufacturers submitting NDAs do not necessarily need to submit three batches produced
at commercial scale as proof of process validity—a specific number of batches is no longer suggested.

During her speech, Woodcock said that since FDA and industry really have the same customer—the patient—the two can work together to achieve the same goals. “FDA regulates product quality. If processes are in control, then quality is under control,” she said.

FDA, therefore, will be watching to see how much control you have over your processes. And packaging is one of those processes. “We see nothing worse and more inefficient than batch inconsistencies,” she said. And all firms will be expected to demonstrate that they can maintain control. “For no product category will we give up inspections. It just means for some products, some inspections will be more intense.”

Perhaps the good news is that FDA won’t be so quick to tell you how to control your quality. “We now have a dispute resolution process whereby companies can appeal technical decisions,” said Woodcock. “We encourage people to use it. If our approach doesn’t contribute to the quality of your product, you should stand your ground. Science is about the open exchange of ideas.”

In other words, don’t hold back. Show FDA that you are in control.