FDA Invites Comments on Quality Metrics

The FDA is requesting public comments on planned changes to the agency’s quality metrics reporting program, specifically on two pilot programs, its Site Visit and Quality Metrics Feedback programs.

Launched in June 2018, the voluntary quality metrics program is designed to improve the  agency’s understanding of how industry uses quality metrics in practice. The site visit program involves visits by Office of Pharmaceutical Quality staff members to observe operations of commercial manufacturing, pilot plants and testing for training purposes.

The changes the agency is considering would mean less standardization of quality metrics and definitions, allowing individual facilities more leeway to focus on “sustainable product quality and availability,” the agency said.

The deadline for comment is June 7.