Month: November 2024

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…