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USP–NF PF 51(3) draft introduces new PAT, content uniformity, parenteral leachables, and CBD standards, enhancing GMP control and regulatory alignment....
Discover the 2025 USP update on elemental impurities: key changes, harmonization across pharmacopeias, and compliance insights....
RABS vs Isolators: Key differences, Annex 1 expectations, and how to choose the right barrier system for your aseptic manufacturing...
Learn the key differences between method validation and verification in pharma labs, with clear guidance on when each applies and...
ICH Q1 draft released: a unified guideline for stability testing with new content on lifecycle, in-use studies, modelling, and advanced...
Solvent-free melt granulation improves flowability, compressibility, and drug release. Learn its process, advantages, equipment, and pharma applications....
Ph. Eur. adds rFC to BET (2.6.14) and updates pyrogen testing (5.1.13) to support sustainable, animal-free methods in line with...
FDA warns Yangzhou Sion for CGMP violations, citing failures in component testing, QC oversight, and data integrity. CAPA plan and...
The FDA has issued a warning letter to Aspen SA Sterile Operations for serious CGMP violations, including failures in lab...
FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its...

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