After Issuing 40 Drug GMP Warning Letters in FY 2012, FDA Aims to Improve Drug Quality This Year
This article was originally published in The Gold Sheet
FDA Commissioner Margaret Hamburg said that improving drug product quality will be one of the agency’s highest priorities this year and advised industry to do the same as the agency spearheads a number of new initiatives in this area. Yet is FDA taking a similarly aggressive approach to enforcement, given that the number of drug GMP warning letter declined 23%?
You may also be interested in...
Public scrutiny has made 483 results much more impactful than intended, says Howard Sklamberg, former FDA deputy commissioner for global regulatory operations and policy. He reminds stakeholders that information in them is preliminary.
FDA warning letters are up at foreign sites and down at domestic sites as agency ramps up presence abroad. Inadequate OOS investigations and faulty testing of drug components were top violations; contamination was a common issue; firms cited included Novartis, Mylan, Smithkline Beecham, Lonza and Noven.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”