Particulate matter in parenteral drugs has been a known issue for over two centuries. Particular matter could come from any little thing that is involved in the process of making the drug product. Contaminants could come from the environment, packaging for the product, ingredients in the product, reactions of the formula and anything that could…
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Improving Visual Inspection Practices
Improving Visual Inspection Practices, written by Jennifer Markarian with Pharmaceutical Technology, she interviews John Shabushnig, PhD and talks about the need of improving the understanding and practice of visual inspection of parenteral drugs. Their interview gives guidance of where to search for help, as well as what is recommended. PDA and USP have been working together…
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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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