Author: gmpinsiders

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.

FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release, process validation, and stability testing. Explore the corrective actions and…

Explore key sampling methods in environmental monitoring, like air, surface, and personnel sampling, to ensure GMP compliance and maintain cleanroom product safety.

Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria.

Learn about the granulation process in pharmaceutical manufacturing, its types, equipment, and role in improving flowability, compressibility, and product quality

FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety and compliance.

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.

Learn how to create a comprehensive Validation Master Plan (VMP) to ensure consistent product quality and regulatory compliance

Discover the best practices for establishing and managing expiry dates for commercial and in-house prepared reagents in QC labs.

FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and steps for compliance.