In USP <1790> it focuses on detecting and removing units of visible particles; in addition, it promotes the need of preventing particulate contamination—which only comes from identifying the particle. Most pharmaceuticals require an understanding of particulate matter contamination. The ability to identify and characterize a particle is extremely beneficial with improving products within the development…
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Pfizer-BioNTech Vaccine Recall
With the click of a button, The Identifier System could have quickly tracked and traced the origin of the Pfizer-BioNTech vaccine defects and its distribution trail. On March 23, 2021, Hong Kong puts a stop on distributing the Pfizer-BioNTech Vaccine to residents. Many containers were flawed among a batch of 585,000 doses due to packaging…
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What is a Recall?
About 4,500 drugs and devices are recalled yearly in the United States. Prior to these recalls, they were approved by the FDA, widely injected, implanted and ingested by customers. The FDA does not initiate a recall, they simply express concern and leave it up to the manufacture to execute a recall. The FDA can only…
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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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