Category: Regulatory Compliance & FDA Insights
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USP <1231> Is Changing: Is Your Pharmaceutical Water Program Ready?
USP 1231 is being revised. Learn how proposed changes involving representative sampling, online TOC and conductivity, ozone, added substances, sterile packaged waters,…
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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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FDA 483 Microbiology Trends for 503A & 503B Facilities
Recent FDA inspection findings send a clear message to 503A compounding pharmacies and 503B outsourcing facilities: a passing sterility test is not…
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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…
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Hello World!
Hello, world. Meet PlumGXP—a microbiology testing laboratory in Allentown, Pennsylvania, bringing experienced scientists, advanced technology, and personal support to pharmaceutical, biotechnology, and…