Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
|Articles|November 15, 2016
- Pharmaceutical Technology-11-15-2016
- Volume 2016 eBook
- Issue 3
Microbiological Testing: Time is of the Essence
Author(s)Cynthia A. Challener
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing models.
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Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbial contamination or bioburden levels, analyzing endotoxins, and implementing environmental monitoring programs.
Growing pressures to increase productivity, flexibility, and cost-effectiveness and the unique properties of many next-generation therapies are challenging today’s microbiologists.
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Investigation Effectiveness Drives Human Performance Excellencealmost 10 years ago
Is Global Regulatory Gridlock Slowing Modernization?almost 10 years ago
Paperless Batch Records for the Massesalmost 10 years ago
Could Greater Transparency Improve Pharmaceutical Quality and Compliance?almost 10 years ago
Ensuring Quality in Pharmaceutical Raw MaterialsAdvertisement
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