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Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
West’s Peg Frandolig and Lynn Lundy share how vision inspection systems can help drug product manufacturers and packaging suppliers work together to regulate foreign and particulate matter in finished drug products in the December/January issue of <em>Pharmaceutical Formulation & Quality</em>.
From May 13 to June 4, team members at our Exton, PA site banded together in our annual West without Borders (WWB) Giving Campaign in the hopes of making a big difference for Fox Chase Cancer Center and Suicide Awareness Voices of Education (SAVE).
The rise in type 2 diabetes has sparked a variety of treatment options, including glucagon-like peptide-1 (GLP-1) receptor agonists. GLP-1s are a class of injected drugs (additional oral options are currently in development) that “mimic the action of GLP-1 and increase the incretin effect in patients with type 2 diabetes, stimulating the release of insulin.”<sup>1</sup> Commonly used when oral treatment alone is not enough, the benefits of GLP-1s include a reduction of glucagon and glycosylated haemoglobin (HbA1c), weight loss and a low risk of hypoglycemia.<sup>2</sup>
<em>Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components</em><br />The visual inspection of injectable drug product has been a regulatory requirement since 1936<sup>1</sup>, 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 zero<sup>2</sup>. Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.<sup>3</sup> Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.”<sup>4</sup>
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