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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)1.
Therefore, performing a root cause analysis for particles is definitely neither an easy nor simple task. However, an analysis is necessary to prevent further occurrences of similar particle issues.
For injectable products, particle issues become even more crucial. This is because there is the risk that small particles in the drug product could be drawn into a syringe and subsequently injected into the patient. Depending on a number of factors2—including the nature of the particle, particle size and shape, and patient population—a contaminated injectable product has the potential to result in inflammation, allergic reactions, or blocked vessels, which can cause damage to tissues and organs and may even be life threatening if vital organs are affected. When particles are found in a vial of injectable drug, it will be a race against time to determine the source of the particles, the extent of the issue, and the impact of the defect. The defective product will also need to be removed from the market.
Based upon our experience, West has developed the following questions to help a drug manufacturer deduce the source of the particle, better understand the extent of situation, and ultimately resolve the issue regarding the closure as a potential source of particulates.
West has developed a range of NovaPure® components, following Quality by Design (QbD) principles that help mitigate risk related to particulate. With our pharmaceutical customer’s goal in mind, Quality Target Product Profiles (QTPPs) have been defined for NovaPure® that include “Drug Product Compatibility – Fit for Use” with a Critical Quality Attribute (CQA) “Particle Characterization” and very low particle count limits are established for visible and sub-visible size ranges.
With quality built in from the start, NovaPure® components can help to reduce risk of defective drug products with its high quality standards and better consistency.
References:
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
<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Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components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 parenteral drug products have been a major source of product recalls in recent years (>100 from 2010-16). They are especially problematic for biologic drug products, where they can induce formation of protein particulates that may have immunogenic effects.
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.
The presence of particulate matter (PM) in parenteral drug products is a well-known challenge for pharmaceutical companies due to the potential quality and safety risks involved. In biotherapeutics, critical attributes related to efficacy, potency, clinical safety, and immunogenicity can be affected by PM.<sup>1-3 </sup><br />PM is defined as extraneous mobile undissolved particles (excluding gas bubbles) that are unintentionally present in solutions.<sup>4</sup><br />Several USP chapters describe the measurement of PM, namely:
Subvisible particulates (defined as those in the 0.1-10 micron range) are a growing concern for injectable drug manufacturers. The particles may cause aggregation, which can impact the drug product and create a potential safety risk for the patient. To help ensure product quality, the U.S. Food and Drug Administration recommends that manufacturers gain a better understanding of how subvisible particles impact the drug.
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