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Learn how to detect, manage, and investigate Out-of-Trend (OOT) results in pharma to maintain product quality, ensure GMP compliance, and prevent OOS issues.
Explore the impact of toxic solvents in Reversed Phase Chromatography, their risks, and eco-friendly alternatives to ensure safe, accurate testing in pharmaceutical QC labs while minimizing environmental hazards.
Discover the key differences between FEFO, FIFO, and LIFO in pharmaceutical inventory management. Learn how each method impacts regulatory compliance, product quality, and operational efficiency in GMP/GDP-regulated warehouses.
Explore key sampling methods in environmental monitoring, like air, surface, and personnel sampling, to ensure GMP compliance and maintain cleanroom product safety.
Learn about the granulation process in pharmaceutical manufacturing, its types, equipment, and role in improving flowability, compressibility, and product quality
Discover the key differences between RP-HPLC and NP-HPLC. Learn how these contrasting chromatography techniques drive effective compound separation and analysis for diverse applications.
FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety and compliance....
FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and steps for compliance....
EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open for feedback until Sept 30,...
FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation, and labeling issues....
FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification....
EDQM comes with a comprehensive summary of the top 10 deficiencies that were observed during the evaluation of CEP applications for chemical purity in 2023....