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Explore how risk management in CSV optimizes validation by focusing on critical functions, ensuring compliance and efficient use of resources.
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.
Revised EDQM guideline explains how to read a CEP, covering CEP 2.0, site details, impurities, and regulatory declarations for better compliance....
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....
