Focusing on a targeted group of patients and trials has led to more small batch productions throughout the industry. These products are often expensive and very limited within the pharmaceutical industries. When having a limited amount of product for manufacturing, issues and rejects must be near zero. Although, product loss is unavoidable—most product loss is…
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Particulate Identification
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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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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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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