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A practical guide to Good Documentation Practice (GDocP) in pharma, covering ALCOA++, data integrity, inspections, electronic records, and compliance controls.
Software validation vs verification explained under EU GMP Annex 11, FDA 21 CFR Part 11, and GAMP 5, with practical examples and inspection-ready guidance.
Terminal sterilization vs aseptic processing explained. Compare sterility assurance levels, risks, validation expectations, and GMP regulatory guidance.
Understand GAMP 5 with simple guidance on lifecycle control, validation deliverables, software categories, and risk-based decision-making in GMP environments.
Primary vs secondary reference standards explained: definitions, qualification, traceability, uncertainty, and regulatory expectations in GMP labs.
Overview of ISO 5 cleanroom standards, airflow control, monitoring requirements, and qualification steps under ISO 14644-1
FDA’s 2025 CSA guidance introduces a risk-based approach to software assurance, reducing burden and aligning with ISO 13485:2016 compliance....
FDA issues Warning Letter to Somerset Therapeutics citing major cGMP failures in aseptic practices, investigations, and reporting....
Draft revisions to GMP Chapter 1 focus on risk-based oversight, early warning systems, supply chain risks, and improved Product Quality Reviews....
USP–NF PF 51(5) draft introduces updates in microbiology, transport, particulates, and dosage form guidance, emphasizing risk-based GMP compliance....
PDG updates Q09 on sub-visible particulate contamination after 20 years, harmonising standards for safer parenteral medicines....
ICH Q3E draft outlines global guidance for Extractables & Leachables, covering scope, risk assessment, AET, and regulatory expectations....
