WHO Prequalification and Inspection Systems – Pharma GMP

Overview of the WHO Prequalification Program: Scope, Process, and Global Role

digi — Sun, 25 May 2025 22:48:32 +0000

Overview of the WHO Prequalification Program: Scope, Process, and Global Role Understanding the WHO Prequalification Program: Scope, Process, and Global Impact The WHO Prequalification Program (PQP) is one of the most influential regulatory frameworks in the global public health landscape. Designed to ensure the safety, efficacy, and quality of essential medicines, diagnostics, vaccines, and active...

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...

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...

How to Prepare for a WHO PQP Facility Audit

digi — Mon, 26 May 2025 18:16:15 +0000

How to Prepare for a WHO PQP Facility Audit Essential Steps to Prepare for a WHO PQP Facility Audit For pharmaceutical manufacturers aiming to supply to global health organizations like UNICEF, Global Fund, or GAVI, obtaining WHO Prequalification is a key milestone. At the heart of this process lies the WHO PQP facility audit, a...

WHO Site Master File Requirements for GMP Prequalification

digi — Mon, 26 May 2025 22:56:27 +0000

WHO Site Master File Requirements for GMP Prequalification WHO Site Master File Requirements for GMP Prequalification The Site Master File (SMF) is a foundational document required during the WHO GMP prequalification process. It provides a comprehensive overview of a pharmaceutical manufacturing site’s quality system, infrastructure, operations, and compliance framework. As a core submission component under...

Common Deficiencies Observed in WHO GMP Inspections

digi — Tue, 27 May 2025 05:42:09 +0000

Common Deficiencies Observed in WHO GMP Inspections Top GMP Deficiencies Commonly Identified During WHO Inspections WHO GMP inspections are globally recognized for their rigor and structured evaluation of pharmaceutical manufacturing facilities. For companies seeking WHO prequalification, understanding the common deficiencies observed during WHO GMP inspections is crucial for proactive risk mitigation and audit preparedness. This...

WHO PQP for Finished Pharmaceutical Products (FPPs): A Complete Guide

digi — Tue, 27 May 2025 12:09:59 +0000

WHO PQP for Finished Pharmaceutical Products (FPPs): A Complete Guide A Complete Guide to WHO Prequalification for Finished Pharmaceutical Products (FPPs) The WHO Prequalification Programme (PQP) for Finished Pharmaceutical Products (FPPs) is a globally recognized pathway that assures the quality, efficacy, and safety of essential medicines for procurement by international agencies such as UNICEF, Global...

Inspection Criteria for APIs Under WHO PQP

digi — Tue, 27 May 2025 19:13:36 +0000

Inspection Criteria for APIs Under WHO PQP Understanding WHO PQP Inspection Criteria for Active Pharmaceutical Ingredients (APIs) The quality of an Active Pharmaceutical Ingredient (API) is fundamental to the safety and efficacy of a finished pharmaceutical product (FPP). As part of the WHO Prequalification Programme (PQP), API manufacturers may undergo direct evaluation and inspection to...

WHO PQP for Vaccines and Biological Products

digi — Wed, 28 May 2025 01:08:14 +0000

WHO PQP for Vaccines and Biological Products WHO Prequalification Programme for Vaccines and Biological Products: A Complete Overview The WHO Prequalification Programme (PQP) is a critical mechanism for ensuring the safety, quality, and efficacy of vaccines and biological products intended for use in global immunization programs. These products, due to their complex nature, require rigorous...

Understanding WHO’s Risk-Based Inspection Model

digi — Wed, 28 May 2025 06:16:05 +0000

Understanding WHO’s Risk-Based Inspection Model Decoding WHO’s Risk-Based Inspection Model for GMP Oversight In the evolving landscape of pharmaceutical regulation, resource-efficient oversight is critical. The World Health Organization (WHO) has adopted a risk-based inspection model under its Prequalification Programme (PQP) to prioritize GMP inspections for pharmaceutical manufacturers. This model helps determine inspection frequency, scope, and...