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In drug and device manufacturing, sterile means precisely what it says: The total absence of viable microorganisms. Obviously, not everyone is meeting this standard:
Poor microbial contamination control is now a top Form 483 observation. The focus to date has been on compounding pharmacies, but no FDA- or EU-regulated manufacturer is exempt from its country’s purity laws.
Now’s the time for a hard look at your manufacturing processes.
This timely new management report from FDAnews spells out how U.S. and EU manufacturers must handle sterile processing, focusing first on the basics:
You’ll examine in-depth the two methods to manufacture sterile medicinal products:
Equally important — primary product packaging. This report offers clear guidance to the appropriate package sterilization method for every sterile product you offer.
Here’s just a sampling of specifics covered:
The New England Compounding Center (NECC) has just agreed to a $100 million settlement in the meningitis case. That’s the last thing your company wants to face.
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