Published in Pharma’s Almanac, February 2016
The author (Guy Villax) presents his views about the latest update of FDA's guidance which includes quality culture.
It’s Official! FDA has introduced Quality Culture in its guidance – although still in draft, it signals a sea change at the agency. No longer will FDA focus solely on compliance. Pharmaceutical manufacturers will be recognized for excellent performance. Pharma companies that rely on contract service providers will be able to use Quality Metrics and New Inspection Protocol Project (NIPP) performance scoring to make better decisions when it comes to selecting CDMOs.