On November 23, 2016, the Food and Drug Administration (FDA) published a revised draft guidance for Submission of Quality Metrics Data. The guidance includes significant changes to the earlier quality metrics draft guidance issued by the agency on July 28, 2015.
FDA's Quality Metrics Initiative, announced in April 2013, encourages pharmaceutical firms to embrace continuous improvement and foster a culture of quality by collecting and reporting manufacturing quality data. During the comment period for the 2015 draft guidance, manufacturers acknowledged that the initiative has the potential to transform the way the pharmaceutical industry approaches overall product quality and the reliability of the supply chain. However, manufacturers and participants in ISPE’s Wave 2 Quality Metrics Pilot Program, conducted across 28 companies (83 sites, 60 products), expressed concerns over lack of clarity regarding implementation, timelines, definitions, and evaluation guidelines.
Posted by Dr. Tim Sandle