The Review on WHO Pre-Qualification for Vaccine Manufacturing

Rajneesh Verma¹, Yogesh Shelar^2*, Venkatesh, M. P.² & Manoj Bansode³

¹Stem Cells 21 co. Ltd, 2^nd & 7^th fl, Urbis bld, Aetas Residence, Soi Ruamrudee, Bangkok, Thailand
²J.S.S. College of Pharmacy, Sri State Highway 17 Near Fire Station, Shivarathreeshwara Nagar, Mysuru, Karnataka
³Saiseva Biotech Pvt Ltd, Curecells^TM Cord Blood Bank, Kant Helix, Bhoir colony, Chinchwad, Pune, Maharashtra

Dr. Yogesh Kashinath Shelar, J.S.S. College of Pharmacy, Sri State Highway 17 Near Fire Station, Shivarathreeshwara Nagar, Mysuru, Karnataka.

Keywords: Vaccine Manufacture; Immunization; Prequalification Procedure

Abstract

Supply chain management of vaccine is a crucial part in national immunization program. The vaccines used during this program should have to pass global standards for safety, efficacy and quality. To define these global standards the World Health Organization (WHO) vaccines prequalification programme was started in 1987 [1]. Prequalification is the procurement term which helps to scrutinize the global public tender to limiting the best possible supplier for vaccine and immunization related devices.
This article describes the purpose of prequalification and the regulatory requirement for prequalification of vaccines in India. The article also describes the procedures for participation in prequalification programme by WHO along with requirements for vaccine production to the submission procedure to WHO. The article also includes the most common issues and difficulties faced by Indian manufacturers during the process of WHO-prequalification program.

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).