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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Testing Container Closures
During the manufacturing process of injectable drugs, all pieces and parts need to go through a visual inspection process. The container, closure, product and final product all need to have individual inspections. Container closure integrity is extremely important, especially when involved with parenteral drugs. Parenteral drugs have the highest risk packaging application concern for closure…
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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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