Innoveix Pharmaceuticals, Inc. recently voluntarily recalled lots of sterile compounded drug products. Semorelin/ Ipamorelin 3mg and injectable AOD-9604 3mg were the products that were recalled from specific Lots. These products were not sterile—when intended to be sterile. Having non-sterile products could lead to life-threatening infections. These products were distributed nationwide to customers and medical facilities.…
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GMP Trends asks “Are you protecting your lab data from deletion or alteration?”
GMP trends published “Are you protecting your lab data from deletion or alteration?” In this newsletter it explains a 483 that a manufacturing lab was caught altering data information. This lab manufacturer did not have a protected system for their data, meaning information is not locked down after being inputted. Information can be altered or…
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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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