“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 Equipment Qualified?
The slightest error or misuse of equipment could lead to an expensive risk, delay manufacturing of a product and minimize the amount of sales. It is necessary to have all items involved in the manufacturing process go through a qualification test. Equipment qualification is extremely critical. Qualification needs to be documented and recorded for both…
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Greenpark Compounding Pharmacy Ophthalmic Recall
Greenpark Compounding Pharmacy produced and distributed compounded products from Prescription Labs Inc. nationwide. These products are intended to be sterile and could be life-threatening if used when not sterile. FDA discovered in July/August that the conditions of Greenpark Compounding Pharmacy’s facility could be causing contamination to the compounded drugs they were manufacturing. On August 18…
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Robotics, Isolators & Restricted Access Barrier Systems
Aseptic Process is the process for manufacturing sterile products where microbiological contaminants could not enter the production area or surface of the product. It is challenging for pharmaceutical manufacturers to ensure that the product they are handling will have absolutely no contaminants—especially if involving parenteral drugs. To isolate human contamination, it is beneficial to use…
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