WHO GMP compliance – 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...

Comparison of PIC/S and WHO GMP Inspection Models

digi — Sat, 14 Jun 2025 01:49:03 +0000

Comparison of PIC/S and WHO GMP Inspection Models Comparing PIC/S and WHO GMP Inspection Models Good Manufacturing Practice (GMP) inspections are fundamental to ensuring the safety, efficacy, and quality of pharmaceutical products. Two of the most influential global frameworks for GMP compliance are the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the World Health Organization (WHO)...

Steps Involved in WHO GMP Site Inspection

digi — Mon, 26 May 2025 12:12:17 +0000

Steps Involved in WHO GMP Site Inspection A Step-by-Step Guide to WHO GMP Site Inspections For pharmaceutical manufacturers seeking global market access through the WHO Prequalification Programme (PQP), understanding the steps involved in WHO GMP site inspections is critical. These inspections assess whether a manufacturing facility complies with the World Health Organization‘s GMP standards and...