EMA Report Shows 350 GMP Inspections in First Half of 2015

The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows.

The number of GMP inspections nearly reached the annual forecast for the entire year, causing the agency to revise its 2015 forecast from 390 to 425. By comparison, inspections totaled 235 for the first half of 2014.

The EMA also met its half-year target of conducting 10 percent of routine GMP reinspections of manufacturing sites using an exchange of information with international partners.

The EMA’s mid-year report, released last week, also shows pharmacovigilance monitoring running even with 2014, with 10 inspections, while the number of good laboratory practice inspections increased from zero to one and good clinical practice audits edged up to 35, from 33 a year ago.

Read the report here: www.fdanews.com/10-15-EMA-Report.pdf. — Jonathon Shacat