Consistency, GMP Guidance Are Lead Priorities at OCP
The FDA’s Office of Combination Products is working to finalize guidance on combination product GMPs, an OCP official says.
Specific concerns being addressed include design control issues for legacy products, cross-labeling where a drug and device are meant to be used together but may be made by separate manufacturers, and staff training before inspections that would focus on combination GMPs.
“If the review pathways ask different questions about similar products, that’s a problem,” John Barlow Weiner, assistant director for policy in OCP, told a session of MedCon 2015 in Cincinnati. “We want consistency.”
The comment period on the guidance closed in late April and a preliminary review shows feedback is largely positive. Still, companies are requesting clarification on certain terms, such as the difference between a manufacturer and a sponsor.
Devicemakers also want more information on the role of suppliers in the manufacturing process — for example, whether GMPs would be imposed on makers of components for use in a combination product if they don’t make the finished goods, Weiner says.
He singled out the use of reserve samples to explain how companies might work together through a trade group to draft a proposal for an entire device class with the aim of ensuring guidance is properly addressed.
Explaining the need for staff training, Director Thinh Nguyen said OCP issued 17 product designations in 2014 after the manufacturer and the FDA couldn’t reach agreement on how to review a product. Of those, five were drug-device combinations, one was a drug-biologic and two were innovative drug-device-biologic combinations. The remaining nine products were not considered combination products.
Because combination products blur the lines among drugs, biologics and devices, the challenge is determining which rules take precedence — drug GMP rules or device QSR rules. FDAnews’ The Essential Guide to Combination Products cGMPs will break down the regulation requirements and help you stay compliant.