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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Novavax’s COVID-19 Vaccine
Novavax created the fourth COVID-19 vaccine that could be available in the US this year. This vaccine is reported to be a two-dose regimen and is highly effective out of all other US vaccines during the clinical trial. Novavax is seeking FDA approval and authorization while in the third quarter of their testing. Novavax is…
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Removing Gaps in Data Integrity
Between January 2015 and May 2016 there was a total of 28 warning letters issued to pharmaceutical manufacturers. 21 of those letters were centered around issues involving data integrity. If data is mutilated and changed, it does not promise that a product is safe, data integrity is extremely important to follow. It is used to…
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Manual Visual Inspection is Still Critical
Automated visual inspection has been created to perform as an alternative to manual visual inspection. This type of inspection is used to lower the cost and speed up the inspection process; pushing more drugs into the market. In USP <1790> it explains that any inspection other than manual inspection has to be “equivalent or better…
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