10% of drugs sold around the world are fake. Counterfeit medicines are the cause of on average 1 million deaths yearly. Increasing of online purchases and disrupted supply chains have intensified and made the risk of counterfeit medicines due to COVID-19. Drugs are “tracked” once after the product has left the manufacturer and landed where…
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Sagent Pharmaceuticals, Inc. Issues Nationwide Recall
November 19, 2021, Sagent Pharma announces a voluntary nationwide recall of Levetiracetam Injection. Four lots of Levetiracetam was recalled due to the lack of a sterile product. Issues pertaining to container closure integrity was brought to attention when found in reserve sample vials. Sagent Pharmaceuticals did not follow USP suggested guidelines for container closure integrity—distributing…
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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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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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