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Practice-oriented guide to pharmaceutical complaint management: definitions, risk-based triage, investigations, CAPA, recall interfaces, and trending KPIs.
What moist heat sterilization really means in GMP: mechanisms, cycle types, limitations, and regulatory expectations beyond 121 °C for 15 minutes.
Comparison of Annex 11 and 21 CFR Part 11, with practical takeaways on validation, governance, risk management, audit trails, electronic records and signatures.
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.
FY 2025 FDA inspection observations reveal recurring weaknesses in drug and medical device manufacturing, highlighting quality maturity, governance, and lifecycle control....
This FDA Warning Letter analysis examines how weak investigations, ineffective contamination control strategies, and batch-release-driven decision making allowed contamination risks to persist at Catalent Indiana’s...
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....
