Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|May 15, 2016
- Pharmaceutical Technology-05-15-2016
- Volume 2016 eBook
- Issue 2
Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations
Author(s)James P. Agalloco
This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.
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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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Articles in this issue
over 10 years ago
Measuring and Removing Genotoxic Impuritiesover 10 years ago
Qualification and Validation of Single-Use Shipping Systemsover 10 years ago
Lessons Learned Accelerate Vaccine Developmentover 10 years ago
Protecting the Product and the Patientover 10 years ago
Deconstructing the Regulatory SpiralAdvertisement
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