Tag Archives: Defect Tracking

What to Expect from A Remote Inspection

COVID-19 created many changes in the world today.  We had to alter our daily routines, within work, home and social life.  The pharmaceutical industry had to work hard in this situation by staying safe, but moving fast. Remote inspection was one of the greatest differences made during the pandemic.  The pharmaceutical and healthcare industry plan…
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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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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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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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