By John Rech, West Pharmaceutical Services, Inc.

Published in: Pharmaceutical Online Newsletter

Published on: October 11, 2023

The visual inspection of injectable drug product has been a regulatory requirement since 19361, however, successful implementation of the standard has been challenging for many organizations. The number of recall notices issued by the U.S. Food and Drug Administration (FDA) from 2010 through 2019 for injectable products due to visible particulate have reduced since 2014 but at the current trend, will be some time before it approaches zero2. Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.3 Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.

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