Regulatory Requirements for Participation in WHO Prequalification Programme for Parenteral Products

Abstract

The Parenteral Product like IV injections, vaccines, etc which is very sensitive including their manufacturing process, storage all plays very important role. A small mistake can destroy the pharmaceutical product and also dangerous for the human kind. Also, in a COVID-Era, we know the importance of the parental product and their life cycle management.

So, this article focuses on the World Health Origination Pre-Qualification Programme which plays very important role in the parenteral product Safety, Quality And their efficacy.

The article contains WHO Prequalification Programme Framework in which all the parameters and its evaluation frameworks. The WHO PQ various stages and their market impact that it can help industry and they can show that their product have the Quality that’s why they have WHO PQ Acceptance Letter. The article review that what is GMP requirements that WHO PQ wants. They also included the how to risk Management and quality Control is necessary. It is also very importance of Stability studies and requirements, for parenteral product this step is very necessary, as stability of parenteral product is very important. The WHO PQ also requires CTD or eCTD dossier which includes various Modules.

Conclusion: The WHO Prequalification Programme plays a crucial role in guaranteeing that injectable products meet global standards for quality, safety, and efficacy by conducting thorough GMP inspections and evaluating CTD dossiers, particularly Module 3 (Quality). For those working in Regulatory Affairs, obtaining WHO PQ approval enhances the product's credibility and facilitates participation in international tenders.