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Explore the full lifecycle of GMP deviation management—from detection and investigation to CAPA and trending for regulatory compliance and quality assurance.
RABS vs Isolators: Key differences, Annex 1 expectations, and how to choose the right barrier system for your aseptic manufacturing process.
Learn the key differences between method validation and verification in pharma labs, with clear guidance on when each applies and how to stay compliant.
Solvent-free melt granulation improves flowability, compressibility, and drug release. Learn its process, advantages, equipment, and pharma applications.
Look into the key differences between reference and retention samples in pharma, their roles in GMP, storage rules, and regulatory guidelines for compliance.
Learn how to choose the right Biological Safety Cabinet (BSC) for your lab. Explore BSC types, features, biosafety levels, and compliance essentials.
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 safety. Issues ranged from inadequate...
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, process validation, and stability testing....
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 and compliance....
