GMP Insiders

he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer safety. Issues ranged from inadequate testing of drug products to…

Prepare for GMP inspections with these 10 tips, including audits, updated documentation, staff training, mock inspections, and setting up a war room.

Explore the key differences between powders, granules, and tablets in pharmaceuticals, including their advantages, disadvantages, and manufacturing approaches.

EDQM releases draft chapter 5.38 on data quality in pharma, emphasizing standards, governance, and SME involvement.

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.

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.