Article


The Review on WHO Pre-Qualification for Vaccine Manufacturing

Rajneesh Verma1, Yogesh Shelar2*, Venkatesh, M. P.2 & Manoj Bansode3

1Stem Cells 21 co. Ltd, 2nd & 7th 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, CurecellsTM 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.

View Full Text | Download PDF

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).

Total Articles Published

4
8
4


Track Your Article







Highlights


Cient Periodique is a ‘Gold’ open access publisher that aspires to offer absolute free, unrestricted access to the valuable research information

We welcome all the eminent authors to submit your valuable paper

Cient Periodique invites the participation of honourable Editors and Authors

CPQ Journals provide Certificates for publication

Cient Periodique also offers memberships for potential Authors

Best Articles will be appreciated with the provision of corresponding Certificate