Author: gmpinsiders

Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and participant safety.

Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health.

The United States Pharmacopeia (USP) has released  Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents for early adoption, outlining using non-animal-derived reagents in bacterial endotoxin testing. The guidelines are part…

Learn how Good Chromatography Practices enhance data integrity, ensure compliance, and boost efficiency in pharmaceutical labs for reliable, safe product outcomes.

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.