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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–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....
ICH Q1 draft released: a unified guideline for stability testing with new content on lifecycle, in-use studies, modelling, and advanced therapies....
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 modern QC practices....
FDA warns Yangzhou Sion for CGMP violations, citing failures in component testing, QC oversight, and data integrity. CAPA plan and timelines included....
The FDA has issued a warning letter to Aspen SA Sterile Operations for serious CGMP violations, including failures in lab controls, aseptic practices, data integrity,...
