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Discover the key differences between CSV and CSA in pharma, shifting from document-heavy compliance to risk-based assurance
Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready.
Explore Annex 1 PUPSIT requirements, causes of filter damage, and how proactive integrity testing strengthens sterility assurance in aseptic processing.
Bioburden testing in pharmaceuticals: methods, validation, and regulatory expectations for microbial control and sterilization assurance.
Explore HEPA filter types used in pharmaceutical cleanrooms. Understand H13 vs H14, ULPA, gel-sealed filters, and Annex 1 testing requirements.
Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices.
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,...
FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its products on Import Alert 66-40....
FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key findings and corrective actions inside....
Discover the key updates in USP–NF PF 51(2), including revisions to chromatography, analytical instrument qualification, microbial contamination control, solubility measurements, and residual solvent analysis....
