Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations
This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.
USP requirements for the absence of “objectionable organisms” are well intended, but may often result in the need for subjective, and unrealistic, determinations. This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.
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Pharmaceutical Technology’s 2016 Bioprocessing and Sterile Manufacturing eBook.
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
