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In its Federal Register Notice Docket No. FDA-2015-D-2537, "Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments", the FDA states that it "recognizes that a voluntary phase of the program would give participants an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transparency and a willingness to proactively engage with the Agency in pursuit of the goals described in the revised draft guidance."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the FDA plans to release a new version of the Technical Conformance Guide it issued last June to support the revised draft guidance.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