Recommendations for the preparation, characterization and establishment of international and other biological reference standards, Annex 2, TRS No 932

Overview

A core function of WHO, set out in its Constitution (Article 2), is to “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products” as well as “to standardize diagnostic procedures as necessary”. This responsibility is discharged in part by establishment of biological reference standards that form the basis of regulation and clinical dosing for biological medicines and also for regulation of in vitro diagnostic devices. The process whereby such international biological reference standards are established and the technical specifications with which they comply are set out in this guidance document, which is intended to be scientific and advisory in nature.

Full version of  WHO Technical Report Series No. 932