Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Nitrosamine Impurities in Pharmaceutical Products: Templates for Risk Assessment and Supplier Evaluation

Jun 28, 2025

Supply Chain Traceability of Medicinal Products

May 31, 2025

Continuous Process Verification (CPV) and Evaluation Templates

May 16, 2025

Excipient Risk Assessment: Approach, Templates

Apr 24, 2025

Qualification of Inhouse Reference Standards and Secondary Standards

Apr 14, 2025

Purified Water System Qualification and Control: USFDA Expectations

Feb 11, 2025

Strengthen Analyst Qualification, Reduce Human Errors

Nov 04, 2024

Deficiencies That Lead to Officiation Action, Warning Letter: Learnings From Eugia USFDA 483s

Sep 21, 2024