FDA's Quality Metrics Initiative starts with voluntary Phase

Recommendation

20/21 November 2019
Barcelona, Spain

Quality Risk Management - An ICH Q9 Training Course

The U.S. Food and Drug Administration (FDA) published a revised version of its Quality Metrics Guidance ("Submission of Quality Metrics Data"). The goal of a final guidance will be the collection of quality metrics data from pharmaceutical companies to foster the agency's aim of a risk based inspection planning. A first draft guidance was published in 2015, leading to a lot of responses from industry.

What's new in the revised draft?

• The program will begin with a voluntary phase that will run into 2018. After this rather short period, the program should become mandatory.
• The scope will be narrowed with three different primary metrics instead of four, allowing more flexibility and a reduction in reporting burden: lot acceptance rate (LAR), a product quality complaint rate (PQCR) and an invalidated out-of-specification rate (IOOSR) plus three optional metrics.
• Both product reports and site reports would be possible
• Modifications to the quality metrics data definitions with clarifying examples

In its Federal Register Notice Docket No. FDA-2015-D-2537, "Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments",  the FDA states that it "recognizes that a voluntary phase of the program would give participants an opportunity to demonstrate transparency and a willingness to proactively engage with the Agency in pursuit of the goals described in the revised draft guidance."

Additionally the FDA plans to release a new version of the Technical Conformance Guide it issued last June to support the revised draft guidance.