Stability and GMP Requirements for WHO PQ Submissions – drug safety Stability and GMP Requirements for WHO PQ Submissions: Ensuring Drug Safety The World Health Organization (WHO) Prequalification (PQ) program plays a critical role in ensuring drug safety globally. In light of ongoing regulatory updates and changes concerning stability and Good Manufacturing Practice (GMP) requirements, pharmaceutical professionals need a comprehensive understanding of the latest directives. This article serves as a step-by-step tutorial to navigate the complexities of WHO PQ submissions related to drug safety, focusing on stability data, GMP compliance, and effective pharmacovigilance strategies. 1. Understanding the WHO PQ Process…

Summary of WHO Public Assessment Reports and Product Summaries – qppv pharmacovigilance Summary of WHO Public Assessment Reports and Product Summaries – qppv pharmacovigilance The World Health Organization (WHO) plays a vital role in the landscape of global pharmaceutical regulation, primarily through its Prequalification Programme (PQ). This initiative ensures that medicines meet specific standards of quality, safety, and efficacy for use in various health programs, especially in low- and middle-income countries. As regulatory affairs professionals, it is essential to assimilate the nuances of the WHO’s Public Assessment Reports (PARs) and Product Summaries, particularly regarding qppv pharmacovigilance, to adequately respond to…

WHO’s Approach to Post-Market Surveillance in PQ Products – pharmacovigilance qppv WHO’s Approach to Post-Market Surveillance in PQ Products Introduction to WHO Post-Market Surveillance The World Health Organization (WHO) plays a crucial role in the regulation of pharmaceutical products, particularly those that are prequalified (PQ) for use in low- and middle-income countries. Post-market surveillance (PMS) is a pivotal aspect of this regulation, ensuring that products maintain their safety, efficacy, and quality after reaching the market. This guide provides a comprehensive overview of WHO’s approach to post-market surveillance in PQ products, focusing on the implications for pharmacovigilance, the role of the…

How to Address Queries and CAPAs from WHO PQ Review – drug regulatory affairs How to Address Queries and CAPAs from WHO PQ Review In the context of global harmonization in drug regulatory affairs, the World Health Organization (WHO) Prequalification (PQ) program serves as a pivotal initiative aimed at ensuring the quality, safety, and efficacy of medicines, particularly in low- and middle-income countries. This tutorial aims to provide a comprehensive guide on how to effectively address queries and Corrective and Preventive Actions (CAPAs) arising from the WHO PQ review process. It explores essential compliance measures and regulatory actions required for…

Harmonization Between WHO PQ and National Regulatory Authorities – pharmaceutical drug regulatory affairs Harmonization Between WHO PQ and National Regulatory Authorities The globalization of pharmaceutical drug regulatory affairs signifies an urgent need for harmonizing standards and practices. The World Health Organization (WHO) Prequalification (PQ) program plays a significant role in ensuring the quality, safety, and efficacy of medicines. This article provides a step-by-step guide tailored for regulatory affairs professionals, focusing on the interplay between WHO PQ and national regulatory authorities. Understanding the WHO PQ Framework The WHO PQ program was established to assess the quality, safety, and efficacy of medicines…

WHO PQ for In Vitro Diagnostics: Regulatory Framework – regulatory affairs in pharma WHO PQ for In Vitro Diagnostics: Regulatory Framework The World Health Organization’s Prequalification (WHO PQ) program for In Vitro Diagnostics (IVDs) has become an essential component of the regulatory framework impacting pharmaceutical and clinical research industries globally. In this article, we will provide a detailed, step-by-step tutorial for regulatory affairs professionals in the pharma sector to navigate the evolving landscape of IVD regulation under WHO PQ updates, particularly those anticipated through 2025. 1. Understanding WHO PQ for In Vitro Diagnostics The WHO PQ program aims to ensure…

How to Track WHO PQ Updates via GPRM, TRS, and IRIS – pharmaceutical regulatory affairs How to Track WHO PQ Updates via GPRM, TRS, and IRIS The landscape of pharmaceutical regulatory affairs is continually evolving, driven by changing policies and emerging health threats. This article provides a detailed step-by-step guide to tracking World Health Organization (WHO) Prequalification (PQ) updates using the Global Public Health and Regulatory Management (GPRM), the Technical Report Series (TRS), and the Interactive Regulatory Information System (IRIS). Understanding these updates is vital for professionals engaged in pharmaceutical drug regulatory affairs across various regions, including the US, EU,…

Summary of WHO Technical Meetings on PQ in 2025 – pharmaceutical drug regulatory affairs Summary of WHO Technical Meetings on PQ in 2025 – pharmaceutical drug regulatory affairs In the rapidly evolving landscape of pharmaceutical drug regulatory affairs, staying informed is crucial. The World Health Organization (WHO) plays a vital role in shaping the guidelines and regulations that govern drug approval processes across the globe. This tutorial serves as a comprehensive guide to understanding the implications of the WHO Technical Meetings on Pharmaceutical Quality (PQ) held in 2025, focusing on regulatory intelligence that is essential for professionals in pharmaceutical regulatory…

Advanced WHO PQ Updates Strategies for Global Regulatory Teams – fda pharma regulations Advanced WHO PQ Updates Strategies for Global Regulatory Teams The World Health Organization (WHO) provides critical frameworks to ensure that medical products are safe, effective, and of high quality. As regulatory professionals, leaders within the fields of regulatory affairs, pharmacovigilance, and clinical operations must stay abreast of updates related to the WHO Prequalification (PQ) program. This article presents a comprehensive step-by-step tutorial on advanced WHO PQ updates strategies for global regulatory teams, with a particular focus on navigating the fda pharma regulations and related frameworks. The guidance…

How to Build a WHO PQ Updates Tracker Dashboard for RA and QA – medical writer pharmacist How to Build a WHO PQ Updates Tracker Dashboard for RA and QA In today’s rapidly evolving pharmaceutical landscape, regulatory compliance and quality assurance are paramount. Regulatory affairs (RA) and quality assurance (QA) professionals must remain vigilant in tracking updates from the World Health Organization (WHO) concerning Prequalification (PQ) guidelines. This article presents a step-by-step tutorial on constructing a WHO PQ Updates Tracker Dashboard specifically designed for medical writer pharmacists, ensuring that they can effectively monitor critical updates, enforcement changes, and implement necessary…