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On January 30, 2025, the FDA issued a Warning Letter (320-25-37) to Strukmyer LLC dba Strukmyer Medical, following an inspection...

Differentiate contamination, cross-contamination, and mix-ups in pharma manufacturing. Discover their causes, impacts, and prevention strategies to ensure GMP compliance....
Explore types of airlocks in pharma: Cascade, Bubble, Sink. Learn how they ensure contamination control, cleanroom integrity, and GMP compliance....
Karl Fischer titration essentials - the gold standard for precise water content determination....
FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation...
FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...
Explore the flow properties of powders and granules in pharma manufacturing. Learn key factors, metrics, and methods ensuring product consistency...
Learn how to write SOPs in the pharmaceutical industry. A step-by-step guide on structure, best practices, and ensuring GMP compliance...
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and...
Learn about stability storage conditions in pharma, including long-term, intermediate, and accelerated studies, climatic zones, regulatory guidelines, and strategies for...

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