No pharmaceutical manufacturer want to undergo a Food and Drug Administration inspection, but these checks are a routine part of maintaining compliance with regulatory standards. What companies want to avoid is a Form 483, which inspectors use to document problems. Complicating the matter is a new FDA “quality metrics” initiative, which the agency is pursuing to keep manufacturing standards high. This initiative has some drug companies concerned that the FDA will use these new measures as a way to spark enforcement actions. While that interpretation is understandable, it does not offer a complete picture of the coming regulatory changes.

In mid-2015, the FDA released draft guidance for its “Request for Quality Metrics,” a document that describes how the FDA will evaluate the quality of manufacturing facilities and the processes used in manufacturing pharmaceutical and biological products. The FDA said it developed the document to provide guidance to drugmakers so that they can thoroughly evaluate their products, maintain drug quality, and avoid problems that could cause a product to be recalled.

While the FDA maintains that it wants to keep manufacturing standards high, it is also clarifying that collecting data under its quality metrics initiative is not intended to be a way to spark more 483s. Russell Wesdyk, acting director of the FDA’s Office of Pharmaceutical Quality’s Office of Surveillance, tells FDA News that quality metrics is for surveillance, not enforcement. The metrics gathered from surveillance will be used to prioritize inspections, he explained.

One way to look at the FDA’s quality metrics plan is to regard it as a prospective, rather than retrospective measure. By consistently monitoring manufacturing, companies can take preventative steps. That’s the preferred course to taking remedial actions after an inspection uncovers a manufacturing problem.

The FDA’s regulation of pharmaceutical manufacturing is a complex and constantly evolving matter. Consultants with expertise responding in 483s and warning letters can give drug makers the guidance and assistance they need to maintain compliance. To learn more, contact us.