Vaccine manufacturing deviation reports up by 19% in 2016, US FDA

By Dan Stanton contact

- Last updated on GMT

Image: iStock/Arkadiusz Warguła
Image: iStock/Arkadiusz Warguła
An increase of quality, process control and specification issues contributed to a rise in reported vaccine manufacturing deviations last year, a US FDA report finds.

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.

deviations
Total BPD Reports by Manufacturing System Licensed Non-Blood Establishments FY16
deviations
Total BPD Reports by Manufacturing System Licensed Non-Blood Establishments FY16

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