FDA’s Quality Metrics Proposal Poses Challenges, Including 'Gaming,' Cost
If it works, tracking the four quality metrics outlined in FDA guidance will help the global pharmaceutical supply chain prevent quality failures and drug shortages.
You may also be interested in...
Based on industry feedback from pilot programs, agency proposes for discussion a layered approach to quality metrics reporting that industry sectors and individual manufacturing facilities could tailor to their needs.
US FDA will establish mandatory quality metrics reporting through a formal rulemaking process that could take years. Meanwhile, a revised draft guidance lays out plans for voluntary quality metrics reporting that could begin by January 2018.
Most pharmaceutical manufacturers are adopting or making plans to adopt the continued process verification approach outlined in FDA’s November 2011 process validation guidance, which will shine a light on their manufacturing processes. But not everyone is anxious to see what that light will reveal.