Particulate matter was found in an Amino Acid Injection in September. ICU Medical, Inc. voluntarily recalled one lot of Aminosyn II, 15% of 2,112 units. This is a Sulfite Free IV solution used in hospitals. The recall was enforced due to particles such as fibers, hairs and proteinaceous materials. These particles were found when ICU…
Read more
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…
Read more
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…
Read more
Moderna applies for full FDA approval of COVID Vaccine
Over 100 million Moderna shots have been administered to patients and just recently, Moderna reached out to the FDA for their full approval. Tuesday, June 1st, Moderna asked the FDA for a full approval of their COVID-19 Vaccine—the second drug producer in the U.S. to seek a biologics license that will allow it to market…
Read more