Tag Archives: Quality Culture

The Importance of Data Integrity

On January 15, 2021, GMP Trends posted Issue #1056.  In this issue, it states that the FDA found a Pharmaceutical manufacturer’s lab that was not recording data and other information properly for years.  For starters, the equipment calibration and logbook were not updated for 18 months, the possession of the drug products were not tracked…
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Particulates in Parenteral Products and the Search for the Holy Grail

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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