WHO PQ inspections – Pharma GMP

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...

WHO GMP Inspection Guidelines: Scope and Structure Explained

digi — Mon, 26 May 2025 06:00:47 +0000

WHO GMP Inspection Guidelines: Scope and Structure Explained Decoding the WHO GMP Inspection Guidelines: Scope and Structural Overview The World Health Organization (WHO) plays a pivotal role in setting global standards for pharmaceutical manufacturing. Its GMP inspection guidelines, particularly as outlined in WHO Technical Report Series (TRS) 986 and 961, are used worldwide to assess...

GMP Inspection Classifications: Routine, For-Cause, and Special Inspections

digi — Tue, 20 May 2025 22:09:57 +0000

GMP Inspection Classifications: Routine, For-Cause, and Special Inspections Decoding GMP Inspection Types: Routine, For-Cause, and Special Audits Good Manufacturing Practice (GMP) inspections are a cornerstone of pharmaceutical regulatory oversight. However, not all inspections are alike. Regulatory authorities around the world categorize inspections based on their purpose, risk level, and triggers. For Pharma Professionals aiming to...