GMP Actions Could Affect Part 11 Enforcement

Originally Published MDDI August 2003

NEWSTRENDS

Erik Swain

FDA's effort to revamp good manufacturing practices (GMPs) for drugs could have effects on the device industry, an agency official says.

Steven M. Niedelman, FDA's associate commissioner for regulatory affairs, told a device industry audience that 
certain drug-GMP initiatives, such as revamped rules on electronic records and signatures (21 CFR Part 11), will cover medical devices and other FDA-regulated industries as well. He spoke at the annual meeting of the Medical Device Manufacturers Association (MDMA; Washington, DC) in June. 

The agency began reevaluating drug GMPs in August 2002. Goals include incorporating more state-of-the-art science into the review and inspection processes, encouraging the adoption of new technology, improving agency coordination, and providing incentives for firms to implement better quality-management practices. 

There is no specific effort to restructure medical device GMPs, but device manufacturers should be aware of upcoming changes whose reach might extend beyond the pharmaceutical industry, Niedelman said.

One area is part 11, which covers how drug, device, and biologics companies must maintain electronic records and produce electronic signatures. Industry has long complained that the regulation is too confusing and burdensome. FDA has agreed to reevaluate it, and earlier this year withdrew a number of guidances pending that outcome. It also agreed to enforce it less aggressively for now—especially for systems in place before August 20, 1997, the effective date of Part 11. This will extend beyond pharmaceuticals, Niedelman said.

“Part 11 applies to all facets of the agency, and that means devices as well as drugs, biologics, etc.,” he said. “The device industry will need to keep up with the work going on in that area.”

Another development in the drug-GMP initiative is a clarification of precisely what a form 483 citation means. There had been a perception among financial analysts and others who evaluate the industry that a form 483 citation indicated that the firm was not in compliance with GMPs. So 
the agency is adding language to those documents to clarify that that is not the case. The language has also been added to every FDA Web 
site where 483s and warning letters are posted. 

The explanation reads as follows: “This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.”

This statement applies to device 483s as well, Niedelman said. “It applies to any industry that receives a 483.”

Device manufacturers should also pay attention to any changes that affect internal quality-system programs, Niedelman said.

More relevant developments could be on the way, he said. “We are doing a gap analysis of GMPs across the different regulated industries to compare how the GMP systems are enforced,” Niedelman added. “Ultimately, I can't say whether it will or will not have an effect on the device industry. But certainly CDRH is a player in this effort.”

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