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Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.
Moreover, there are no size thresholds established to define what is visible; and data is very limited on patient risks associated with particle sizes and numbers. West, a member of Parenteral Drug Association, is participating in an initiative sponsored by the Pharmaceutical Manufacturers Forum to address these shortcomings and develop test methods for assessing the cleanliness of packaging components.1
The journey toward zero defects for visible particles in injectable drug products starts with thorough evaluation of the pharmaceutical and packaging manufacturing processes for sources of particles, and development of methods for their detection and measurement. The goals of this initiative are to establish a definition of visible particles, and to develop test methods to evaluate if they are present. These methods will then be promoted within both the industry and regulatory agencies. This initiative will focus on ready-to-sterilize, ready-to-fill and ready-to-use components. The methods developed will allow component suppliers and pharmaceutical manufacturers across the industry to use harmonized analytical methods for visible particles. Further risk assessment will be performed to identify actions to further reduce particles originating in the supply chain.
For more on how West can help to address particle concerns visit our website or contact West’s Technical Support.
A parenteral drug product contaminated by particles is a potential health threat. In the bloodstream, particles can cause serious issues, such as capillary occlusion and immunogenic responses. In most cases, the observation of particles in a drug product leads to a recall.
<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Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components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>
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the <em>FDA Recalls, Market Withdrawals, & Safety Alerts</em> database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination<sup>1</sup>.
Particles in parenteral drug products continue to be an important concern. At the April-2017 AAPS Workshop <strong>Challenges and Patient Impact of Particles in Biologics</strong>, Fran DeGrazio, VP of Scientific Affairs and Technical Services, spoke on the topic: <em>Unique Considerations for Testing and Understanding Particle Loads for Primary Packaging Components.</em> <br />
Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)<sup>1</sup>.
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