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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Keys to a Successful Rapid Commercial Launch
In manufacturing, pharmaceutical companies’ drugs are produced in hopes to save patients as fast as they can. It is a “race to the finish” pharmaceutical online stated. Getting the drug products produced and sent out to patients as fast as possible is every manufactures goal. The third highest number of drug approvals in over twenty…
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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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Is Your Sterile Injectable Ready for Changes in Raw Materials?
In any manufacturing company, it is likely that raw material will change from time to time. These changes are modifications in API synthesis, key starter materials and intermediates. These changes are expected and necessary for manufacturing improvement. The best approach to alternating materials from a supplier, is to always keep track and maintain data and…
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