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As regulatory expectations increase, drug product manufacturers face increased pressure to produce products free of defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the ingredients in the drug product, manufacturing equipment or the container closure system.
Regulations, such as USP <1> Injections and <788> Particulate Matter in Injections, have enhanced the complexity and confusion surrounding both visible and subvisible particulate in finished products. For example, USP <1> Injections states that finished injectable drug products must be “essentially free from visible particulates.”1 It does not, however, clearly define the limitations on the quantity of particulate. Referenced in USP <1> Injections, USP <788> Particulate Matter in Injections (harmonized with the corresponding European Pharmacopoeia and Japanese Pharmacopoeia text), provides limitations on particle in the ranges of 10 – 25 um and 25 um and greater. 2 More recently, however, USP <790> Visible Particulates in Injection (effective August 2014) provided some clarity to the statement “essentially free” with a more precise finished drug product sampling plan and AQL definition. 3
As a result of these regulations, greater attention to particulate load in the finished injectable drug products has resulted in increased scrutiny of the individual components constituting the packaging system. Pharmaceutical manufacturers can collaborate with packaging suppliers to reduce particulate matter in finished drug products by supplying components with a focus on minimizing loose, embedded and adhered particulate. For these customers, West offers NovaPure® components, developed under the principles of Quality by Design (QbD). West developed these components using a comprehensive quality target product profile that includes industry leading visible and subvisible particle specifications as part of the component critical quality attributes. In turn, the use of packaging components designed to meet high-quality standards can aid in reducing the risk of rejected drug products.
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NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.
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>.
<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>
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:
Recently, there has been increased scrutiny from regulatory authorities to quantify and qualify subvisible particles in biopharmaceutical products. Such particles, which can cause a protein to denature, are of concern to pharmaceutical manufacturers since they can affect the efficacy of the drug product. As regulatory bodies continue to raise the bar on quality, industry is looking for “zero defect” and particle free components as well as a way to minimize quality variation.
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