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Comparison of Annex 11 and 21 CFR Part 11, with practical takeaways on validation, governance, risk management, audit trails, electronic records and signatures.
A clear guide to the main pharma batch records (MBR, BMR, BPaR, QC logs, EBRs), what each proves, and the GMP/FDA requirements that support batch release.
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.
FDA Warning Letter to Rhyz Analytical Labs cites CGMP failures in OOS investigations and Quality Unit oversight at a contract testing laboratory....
USP–NF PF 51(6) draft updates modernize analytical validation, ophthalmic standards, leachables guidance, and radiopharmaceutical practices....
Pharmeuropa 37.4 introduces updates to residual solvents (2.4.24), cannabis flower (3028), and rubber closures (3.2.9) to improve analytical clarity....
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....
