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Look into the key differences between reference and retention samples in pharma, their roles in GMP, storage rules, and regulatory...
FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key...
Discover the key updates in USP–NF PF 51(2), including revisions to chromatography, analytical instrument qualification, microbial contamination control, solubility measurements,...
CGMP violations identified in the FDA Warning Letter to Marshalls Traditional Healthcare CC, including deficiencies in finished product testing, process...
FDA warns ABR Laboratory LLC for failing to validate test methods and investigate deviations, risking drug safety. Learn key compliance...
Learn the 6 key steps to perform Root Cause Analysis (RCA) in pharmaceutical GMP. Prevent recurrence, improve compliance, and enhance...

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....

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