What standards are applied for vaccines prequalification?

WHO vaccines prequalification applies WHO-established vaccine standards, norms and other recommendations as they become available. These include standards and norms developed and adopted by the WHO Expert Committee on Biological Standardization and which cover vaccine standards that address the manufacturing, licensing, quality control, labelling, transportation and storage of vaccines. Vaccines prequalification also enforces adherence to good manufacturing processes, good clinical practice and the operational packaging and presentation requirements of the relevant procurement agencie(s).