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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.
Learn the 6 key steps to perform Root Cause Analysis (RCA) in pharmaceutical GMP. Prevent recurrence, improve compliance, and enhance product quality.
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....
FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and steps for compliance....
EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open for feedback until Sept 30,...
FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation, and labeling issues....
FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification....
