Tag Archives: quality assurance

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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Testing Container Closures with Dye Ingress Method

The dye ingress test method is a routine test for container closures attached to parenteral drugs and large molecule drugs.  Traditionally, this method uses ten test samples and three positive controls.  During this testing, the test samples are place in a vacuum chamber and pressurized with dye.  Three vials are punctured to allow dye to…
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Pfizer’s Newest Vaccine Plant Has History of Mold Issues and Recalls

On Wednesday, March 10th 2021, WebMD posted an article with information on the newest vaccine plant the FDA are allowing to produce COVID-19 vaccines.  This plant is owned by Pfizer, located in Kansas and is now booked to produce the most urgently needed drug product.  Although, there is one main concern; there is a known…
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The Cloud Benefits Life Science

The cloud is an on-demand accessible computer network hosted on the internet that stores data and allows easy access for collaboration. Due to current events, moving to the cloud has helped a lot of companies keep track of  their data in one location.  It held a lot of value when job locations were compelled to…
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