WHO recommendations for the production, control and regulation of human plasma for fractionation, Annex 4, TRS No 941

Overview

Human plasma is a source of important medicinal products which are obtained by a combination of large-scale processing steps called “fractionation”. It is important that these products have an appropriate quality and safety profile.

Recognizing the importance of the provision of safe blood, blood components and plasma derivatives, the 58th World Health Assembly in 2005 (WHA Resolution 58.13) [1] supports "the full implementation of well-organized, nationally coordinated and sustainable blood programmes with appropriate regulatory systems" and stresses the role of "voluntary, non-remunerated blood donors from low-risk populations". The provision of blood, blood components and plasma derivatives from voluntary, non remunerated donors should be the aim of all countries.

The current document, by bringing together experience and information, will serve as a guide to blood establishments in their implementation of appropriate procedures for the production and control of the starting plasma material, and will facilitate the provision of safe fractionated plasma products at national level. This guidance document addresses only human plasma sourced for the manufacture of plasma derivatives. Plasma for clinical use is not discussed, nor is there any consideration of plasma from other species.

Full version of the WHO Technical Report Series N° 941