EMA inspection findings – Pharma GMP

Root Cause Analysis for GMP Non-Conformities

digi — Wed, 03 Sep 2025 06:00:35 +0000

Root Cause Analysis for GMP Non-Conformities Effective Root Cause Analysis for GMP Non-Conformities Introduction: Why This Topic Matters for GMP Compliance Non-conformities in Good Manufacturing Practice (GMP) are inevitable in complex pharmaceutical manufacturing environments. Deviations, failures, and unexpected outcomes occur despite best efforts. Regulatory bodies such as the FDA, EMA, and WHO expect that when...

Data Integrity Breaches That Led to Site Bans

digi — Tue, 02 Sep 2025 22:43:25 +0000

Data Integrity Breaches That Led to Site Bans How Data Integrity Breaches Resulted in Pharma Site Bans Introduction: Why This Topic Matters for GMP Compliance Data integrity is the cornerstone of Good Manufacturing Practice (GMP). Regulators such as the FDA, EMA, and WHO expect that all records—whether paper-based or electronic—accurately reflect manufacturing and testing activities....