GMP failures – Pharma GMP

Cross-Contamination Control: GMP Rules You Can’t Ignore

digi — Sat, 06 Sep 2025 21:06:50 +0000

Cross-Contamination Control: GMP Rules You Can’t Ignore Essential GMP Rules for Preventing Cross-Contamination in Pharma Introduction: Why This Topic Matters for GMP Compliance Cross-contamination in pharmaceutical manufacturing poses one of the most serious risks to patient safety and product quality. Regulatory agencies such as the FDA, EMA, WHO, and PIC/S consistently identify contamination control failures...

Top 10 GMP Violations Cited in USFDA Warning Letters

digi — Mon, 01 Sep 2025 22:15:00 +0000

Top 10 GMP Violations Cited in USFDA Warning Letters Most Frequent GMP Violations Highlighted in USFDA Warning Letters Introduction: Why This Topic Matters for GMP Compliance The United States Food and Drug Administration (USFDA) inspects pharmaceutical facilities worldwide to verify compliance with current Good Manufacturing Practices (cGMP). When critical deficiencies are found, the agency issues...