- All > Medicine Access and Rational Use > Supply Management
- All > Prequalification of Medicines > WHO-UNICEF-UN Project
- Keywords > biological products
- Keywords > biologicals - manufacture and quality control
- Keywords > Good Clinical Practice (GCP)
- Keywords > Good Manufacturing Practices (GMP)
- Keywords > prequalification for vaccines
- Keywords > prequalification for vaccines - procedure
- Keywords > prequalification of vaccines
- Keywords > vaccines - production and control
- Keywords > vaccines and related substances
(2013; 67 pages)
This document is intended to be scientific and advisory. Each of the following sections constitutes guidance for manufacturers of biological products.
The World Health Organization (WHO), through its Department of Immunization, Vaccines and Biologicals, provides advice to the United Nations Children’s Fund (UNICEF) and other United Nations agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies. This service is called prequalification. The purpose of the United Nations prequalification assessment is to provide assurance that candidate vaccines: (a) meet WHO recommendations on quality, safety and efficacy, including compliance with WHO’s recommended standards for good manufacturing practices (GMP) and good clinical practice (GCP); and (b) meet the operational packaging and presentation specifications of the relevant United Nations agency. The aim is to ensure that vaccines provided through the United Nations for use in national immunization services in different countries are safe, effective and suitable for the target populations at the recommended immunization schedules and with appropriate concomitant products.