Survey Will Help Indian Devicemakers ID QS Issues Ahead of U.S. Inspection

Devicemakers in India that exceed the U.S. FDA’s quality system expectations would receive fewer inspections and other incentives, under a pilot program announced last month.

The new approach would not only offer reduced inspection frequency or intensity, but also a more predictable pathway to implementing manufacturing-related postapproval changes, FDA spokesman Jeff Ventura tells IDDM.

A questionnaire being developed will not only note problems, but could allow the FDA to document where a facility’s quality management system exceeds what would be required to meet regulatory compliance.

The pilot is not directly related to the quality metric collection program that the FDA has recently publicized, Ventura says. He declined to provide further details, citing the agency’s policy not to discuss internal procedures until they are finalized.

The program was highlighted during a recent trip by FDA officials to meet with Indian counterparts and conduct site visits at several facilities. The officials discussed progress with respect to addressing GMP violations in India, with a shared focus on quality (IDDM, March 27). — Jonathon Shacat