pharma quality systems – Pharma GMP

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....

How to Conduct a Gap Assessment for GMP Compliance

digi — Tue, 02 Sep 2025 05:19:10 +0000

How to Conduct a Gap Assessment for GMP Compliance Step-by-Step Guide to Performing a GMP Gap Assessment Introduction: Why This Topic Matters for GMP Compliance Pharmaceutical manufacturers face continuous pressure to demonstrate compliance with Good Manufacturing Practices (GMP) as outlined by regulators such as the USFDA, EMA, WHO, and PIC/S. A GMP gap assessment is...