GMP documentation lapses – Pharma GMP

Real-Life Case Studies of GMP Failure in Indian Pharma

digi — Tue, 02 Sep 2025 13:11:44 +0000

Real-Life Case Studies of GMP Failure in Indian Pharma Case Studies Highlighting GMP Failures in Indian Pharmaceutical Companies Introduction: Why This Topic Matters for GMP Compliance India is one of the largest global suppliers of generic medicines, accounting for a significant share of the pharmaceutical exports to regulated markets such as the United States, the...

Common EU GMP Observations and Deficiencies

digi — Mon, 09 Jun 2025 06:16:41 +0000

Common EU GMP Observations and Deficiencies Frequent EU GMP Observations and Deficiencies in Regulatory Inspections Good Manufacturing Practice (GMP) compliance is vital for pharmaceutical firms operating in or exporting to the European Union. Regulatory inspections conducted by EU national competent authorities (NCAs) and coordinated by the European Medicines Agency (EMA) often uncover patterns of non-compliance....