The creation of intravenous solutions, has led the standard practice of using glass for packaging. Having a glass package for parenteral drugs has been tested and studied in the biopharma industry, giving reasoning to why having glass containers are currently the best solution for parenteral packaging. Although, it may seem like the “best” solution as…
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Serialization Challenges of Track & Trace in the Biopharma Industry
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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Data Integrity Concerns Involving Pfizer’s Vaccine
“We are operating at the speed of science.”, Albert Bourla stated when sharing news about the Pfizer’s vaccine in manufacturing sites in Texas. With the need of these vaccinations, some testing sites in Texas tried to speed up the process and distribute as many products as they could—leading them to go against data integrity and…
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