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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Innoveix Pharmaceuticals, Inc. Recall
Innoveix Pharmaceuticals, Inc. recently voluntarily recalled lots of sterile compounded drug products. Semorelin/ Ipamorelin 3mg and injectable AOD-9604 3mg were the products that were recalled from specific Lots. These products were not sterile—when intended to be sterile. Having non-sterile products could lead to life-threatening infections. These products were distributed nationwide to customers and medical facilities.…
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Robotics in Pharmaceutical Manufacturing
“Robots are proving advantageous in filling, inspection, packaging, laboratories, and the manufacture of personalized medicine.” Automated inspection and packaging are increasing in the pharmaceutical manufacturing industry. There are many benefits to this within the pharmaceutical manufactures. These benefits include: efficiency in saving money with reducing training hours, eliminating human error, saving workers from hazardous environments…
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GMP Trends asks “Are you protecting your lab data from deletion or alteration?”
GMP trends published “Are you protecting your lab data from deletion or alteration?” In this newsletter it explains a 483 that a manufacturing lab was caught altering data information. This lab manufacturer did not have a protected system for their data, meaning information is not locked down after being inputted. Information can be altered or…
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