Discussion forum for Pharma Quality events, Regulatory Actions

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

Qvents Apps and Tools For QMS and GMP Processes

Apr 22, 2026

USFDA Issues Guidance for Impurity Specifications for Semi-Synthetic & Fermentation Antibiotics

Apr 21, 2026

Responding to FDA Form 483: USFDA Issues Guidance

Apr 02, 2026

Imprimis Recall Unapproved Ophthalmic Injections for Glass Particulates in US

Jan 05, 2026

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