WHO PQ inspection model – Pharma GMP

Differences Between WHO PQP and Stringent Regulatory Authority (SRA) Approvals

digi — Sat, 31 May 2025 05:53:24 +0000

Differences Between WHO PQP and Stringent Regulatory Authority (SRA) Approvals WHO PQP vs. Stringent Regulatory Authority Approvals: Key Differences and Strategic Implications The global pharmaceutical regulatory ecosystem includes multiple pathways for product approval and GMP oversight. Among the most prominent are the WHO Prequalification Programme (PQP) and approvals by Stringent Regulatory Authorities (SRAs) such as...

Key Differences Between US, EU, and WHO Inspection Approaches

digi — Tue, 20 May 2025 17:18:19 +0000

Key Differences Between US, EU, and WHO Inspection Approaches Comparing GMP Inspection Approaches: USFDA, EMA, and WHO In today’s global pharmaceutical landscape, manufacturing facilities are routinely audited by multiple regulatory bodies. While harmonization efforts continue to align standards, significant differences persist in the way key agencies—namely the USFDA, EMA, and WHO—conduct GMP inspections. Understanding these...