AI GM GMP Risk Lab. How to Classify GMP Deviations: Minor vs Major vs Critical In GMP environments, deviation classification is one of the most critical and challenging decisions for QA professionals.
GM GMP Risk Lab. Why “Operator Error” is NOT a Root Cause in GMP One of the most common issues in GMP deviation reports is identifying the root cause as “operator error.”
GM GMP Risk Lab. CAPA That Fails in GMP (And How to Fix It) In many GMP deviation reports, CAPA looks correct on paper, but fails during audits.
GM GMP Risk Lab. How to Write an Audit-Defensible Impact Assessment in GMP One of the most challenging parts of deviation handling is impact assessment.