Tag Archives: parenteral products

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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Essentially Free:  How A Definition Tamed The Visible Particulate Matter Debate

In an article written by Louis Garguilo, Chief Editor for Outsourced Pharma, it talks about defining the term “essentially free” of visible particulate matter.  In 2005, it has become a big concern with the number of injectable drug product batches being rejected or recalled because of particulate matter being present. In 2014, recalls in injectable…
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Parenterals, Particulates, and Quality by Design

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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