Tuesday, 22 April 2014

FDA reduces GMP inspection rate

The U.S. Food and Drug Administration (FDA) has announced that it is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent. Instead the FDA will undertake more inspections overseas.


The change has taken place because of FDA concerns with imported medications. The FDA plans to conduct 591 good manufacturing practice (GMP) inspections in fiscal 2014 and 2015 in the U.S. This is down from the 967 performed during 2013-2014. In place, the FDA is aiming to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year. Companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies.

Source: Pharmaceutical Manufacturing

Posted by Tim Sandle