The US Food and Drug Administration (FDA) requires any event associated with the manufacturing of a licensed biological product or a blood or a blood component “in which the safety, purity, or potency of a distributed product may be affected” to be reported to the Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) as soon as possible.
And according to a report published last week, licensed manufacturers of biological products other than blood and blood components submitted 651 biological product deviation reports in 2016 – 93, or 17%, more than the previous year.
Over 40% of reports (or 265) came from vaccine makers which submitted 42 (or 19%) more than in 2015. The highest number of these concerned vaccines not meeting product specifications with most “related to appearance,” though 28 reports involved stability failures.
Meanwhile, “the number of reports involving quality control and distribution [from vaccine makers] increased from 30 in FY15 to 46 in FY16,” the majority involving broken or cracked vials the FDA said.
But while deviation reports involving process controls doubled to 40 among vaccine makers, reports involving testing – mostly due to stability testing being performed incorrectly or not at all – decreased from 43 to 21 year-on-year.