Report Finds QMS Lapses, AE Reporting as Top Major Deviations During EU Postmarketing Inspections

Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year: 18 sites were cited for QMS issues and 13 for problems with AE reporting.

The EMA conducted 167 pharmacovigilance inspections in 2014, down from 195 in 2013. Of those, 58 involved centrally authorized products — 15 more than the previous year, according to a report by the Pharmacovigilance Inspectors Working Party.

The report, which focuses on the 58 CAPs, notes that 10 of those inspections were requested by the EMA’s Committee for Medicinal Products for Human Use, three more than in 2013, turning up 79 deficiencies. Only one, involving organizational structure, was deemed critical.

The rest were split about equally — 40 versus 38 — between major and minor violations and involved problems ranging from clinical trials and safety data analysis to descriptions of pharmacovigilance systems or master files, computerized systems and archiving.

Only one of the 10 inspections CHMP requested involved more than one EU member state.

Pharmacovigilance inspections can be initiated by a member state’s inspection program or by the EMA and are usually product-specific.

Read the report at www.fdanews.com/08-13-15-PhVReport.pdf. — Kellen Owings