Tag Archives: zero defects

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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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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