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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Parenteral Packaging
Small volume parenteral packaging includes packaging sizes from 2 to 5 mL range and is most commonly included with local anesthetics, vaccines and other traditional injectables for patients. Small volume parenterals are used with a luer lock or luer slip that can directly connect to syringes. 10 to 100 mL containers are typically used for…
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