Particulates in parenteral products as well as other pharmaceuticals have gained increased attention from regulatory agencies and from pharmaceutical firms who desire to be in the forefront of patient safety and effectiveness in the products they supply for patients. Foreign particulates in parenteral products come from multiple sources and can vary widely in type, size…
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Controlling for Particulate Matter in Injectable Drug Products
Ever since the development of the earliest intravenous therapies, the presence of particulate matter in injectable drug products has been a concern among clinicians. In recent years, there has been an increase in the number of drug product recalls due to the presence of particulate matter. These recalls are actions taken by a company to remove…
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New Guidance for Visual Inspection
Article Written By: Roy Cherris, Bridge Associates International | May 30, 2017 As an industry, we have been performing 100% visual inspection for visible particles in parenterals for more than 70 years. Yet, during much of this time, there has been a lack of clear guidance, or harmonized scientific approach, for particulate and physical defects.…
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