FDA inspection findings – Pharma GMP

How to Handle a 483 Observation Without Panic

digi — Thu, 04 Sep 2025 22:11:34 +0000

How to Handle a 483 Observation Without Panic Effective Strategies to Handle FDA 483 Observations Calmly and Confidently Introduction: Why This Topic Matters for GMP Compliance During FDA inspections, investigators document potential violations of current Good Manufacturing Practice (cGMP) on Form 483. Receiving a 483 can be stressful for pharmaceutical manufacturers, but it is not...

Common GMP Issues in Tablet Manufacturing

digi — Thu, 04 Sep 2025 12:50:38 +0000

Common GMP Issues in Tablet Manufacturing Frequent GMP Challenges in Tablet Manufacturing and How to Address Them Introduction: Why This Topic Matters for GMP Compliance Tablet manufacturing, as a major component of oral solid dosage (OSD) production, is subject to strict regulatory oversight. Global agencies such as the FDA, EMA, and WHO closely examine GMP...

Why Most Pharma Plants Fail GMP Inspections

digi — Wed, 03 Sep 2025 12:18:43 +0000

Why Most Pharma Plants Fail GMP Inspections Key Reasons Behind GMP Inspection Failures in Pharma Plants Introduction: Why This Topic Matters for GMP Compliance Pharmaceutical manufacturers operate under constant scrutiny from global regulators such as the FDA, EMA, WHO, and PIC/S. A successful GMP inspection demonstrates that a facility is capable of producing safe, effective,...