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FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation...
FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and...
Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and...
USP releases early adoption guidelines for non-animal endotoxin testing, promoting sustainable recombinant Factor C methods with strict validation standards....
he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer...
EDQM releases draft chapter 5.38 on data quality in pharma, emphasizing standards, governance, and SME involvement....
FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release,...
Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria....
FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety...