INDUSTRY GMP IMPLEMENTATION DELAYED BY UNFINISHED GUIDANCE, UNCERTAIN ENFORCEMENT

Industry officials are hesitant to adopt the FDA's planned changes to its good manufacturing practices (GMP) policy until the agency finalizes its new manufacturing requirements, sources say. Manufacturers are also concerned that FDA field inspectors won't consider the new requirements when taking enforcement action.

The FDA is attempting to change companies' manufacturing practices to accelerate drug development and improve product safety and efficacy. To ensure these changes, the agency is implementing new approaches through its initiative, "Pharmaceutical Current Good Manufacturing Practices for the 21st Century."

In particular, the FDA is encouraging the adoption of state-of-the-art quality control systems. These systems call for companies to continually review how they manage variations in temperature, particle size, pressure and flow rate to ensure the final product's quality.

Such changes will allow industry to ensure quality in their product designs up front, rather than making changes after the fact through trial and error, said Moheb Nasr, director of the agency's Center for Drug Evaluation and Research's Office of New Drug Quality Assessment. The FDA wants companies to take a "new, more proactive approach" to manufacturing, Nasr told FDAnews.

While industry believes that a quality control approach is a good move, a lack of regulatory consistency is slowing implementation, said Gordon Richman, vice president of strategic compliance and general counsel of the consulting firm EduQuest. There are "lots of growing pains" within both industry and the FDA, he added.

Specifically, industry is waiting for the agency to finalize its quality systems final guidance, Richman said. The FDA issued its draft policy on GMP, "Quality System Approach to Pharmaceutical Current Good Manufacturing Practice Regulations," in September 2004. Industry hopes the agency will be "more prescriptive and clear" in what it expects from companies in the final version, Richman added.

But the FDA has nearly completed its final guidance, and that document will not be substantially different from the draft, said Joe Famulare, acting director of the Office of Compliance in the agency's Center for Drug Evaluation and Research. The final guidance will be completed this summer, Famulare added. (http://www.fdanews.com/did)