17/18 May 2021
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 A first draft guidance was published in 2015, leading to a lot of responses from industry.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?
In its Federal Register Notice Docket No. FDA-2015-D-2537, "Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments", the FDA states that it "recognizes that a voluntary phase of the program would give participants an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transparency and a willingness to proactively engage with the Agency in pursuit of the goals described in the revised draft guidance."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the FDA plans to release a new version of the Technical Conformance Guide it issued last June to support the revised draft guidance.