FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports

Mar 18, 2014

Pharma Quality Advisor

The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. The shift is part of a broader agency push to improve the quality of drugs imported into the U.S. The change also brings the FDA closer to achieving its longtime goal of bringing parity to U.S. and foreign inspections, so that foreign drug manufacturers would be as likely to be inspected as U.S.-based facilities.

The FDA plans to conduct 591 domestic good manufacturing practice (GMP) inspections in fiscal 2014 and 2015, down from the 967 performed last year. The agency in turn hopes to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year, up from last year’s 604. Companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies. The FDA takes into account risk factors including Class I recalls and adverse events, as well as compliance history, in applying the risk-based inspections model to its decision making.

The new estimates were released in an HHS memorandum supporting the White House’s proposed fiscal 2015 FDA budget...Read the rest of the article in Pharma Quality Advisor