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Learn about stability storage conditions in pharma, including long-term, intermediate, and accelerated studies, climatic zones, regulatory guidelines, and strategies for preserving drug quality, safety, and efficacy across diverse environments.
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.
USP releases early adoption guidelines for non-animal endotoxin testing, promoting sustainable recombinant Factor C methods with strict validation standards.
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…