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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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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