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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Particles in Parenterals: 2019 Update
FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019? Visual inspection of parenteral drug packaging remains a priority for manufacturers and the FDA, as explained by John Shabushnig, PhD of Insight Pharma Consulting and Richard Watson of Merck at the 2019 Parenteral Drug…
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Visual Inspection and Particulate Control
Visual Inspection and Particulate Control is co-authored by our CSO, Roy Cherris, is a practical guide for the control of visible defects and contamination in pharmaceutical products. It is intended for the product inspectors and lab support personnel, as well as those who use inspection results or are responsible for inspection operations. Meant to familiarize…
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