FDA Refines Quality Metrics Program Guidance

As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system.

In a revised draft guidance, the FDA makes changes to an earlier version by adopting the phase-in approach to quality metrics reporting, reducing the number of primary metrics collected, supporting both product and site reports, modifying quality metrics data definitions and clarifying examples for each definition. It also describes the process for submitting comments within a quality metrics data report.

The FDA’s pilot phase of the program will give drugmakers an “opportunity to demonstrate transparency and a willingness to proactively engage with the agency” to monitor quality controls and develop compliance as well as inspection policies, according the agency’s Federal Register notice. And while participation in the pilot is not mandatory, if only a few facilities participate, the FDA might not be able to use the data to help evaluate its planned analytics for the future mandatory program.