Transforming Your Organizational Mindset On Quality Compliance

By John Turanin

This decade, regulatory inspectors will scrutinize your quality culture during site visits, a culmination of seven interrelated actions by the FDA since 2011, which clearly signal their intent to advance quality culture in our industry.

The FDA’s most recent step is the release of Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program (2018). In this pilot, the agency is examining firms’ quality cultures, looking at “routine assessment and management oversight of quality culture … to assess and shape the behaviors, beliefs, values … that characterize or are associated with manufacturing at the facility.”