Category: Pharmaceutical Manufacturing & Quality
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Peptide Drug Demand: Supply-Chain Risks and FDA Inspection Trends
Peptide drug demand is growing faster than qualified manufacturing and testing capacity. This article examines U.S. sourcing challenges for critical building blocks,…
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Are Environmental Isolates Being Used Intelligently?
Every Sample Tells a Story. Environmental monitoring programs generate an enormous amount of microbiological information. Every recovered colony has the potential to…
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Water System Excursions Early Warning Signs
Pharmaceutical water-system excursions rarely appear without warning. Changes in microbial recovery, recurring organisms and gradual shifts in system performance can reveal developing…
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USP Water Testing for Pharmaceutical Manufacturers
Understand the essential elements of USP pharmaceutical water testing—from conductivity, TOC and microbial monitoring to endotoxin control, proper sampling and meaningful data…