Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Processing of donated blood

91% of the blood collected in high-income countries, 72% of that in middle-income countries and 31% of that in low-income countries is separated into components.

Blood collected in an anticoagulant can be stored and transfused to a patient in an unmodified state. This is known as ‘whole blood’ transfusion. However, blood may be used more effectively if component therapy is practiced. One unit of donated blood may be divided into components, including red cell concentrates, fresh frozen plasma, cryoprecipitate and platelet concentrates, to meet the needs of more than one patient.

For a safe and effective blood component processing, the following elements are required:

  • Commitment and support by national health authorities for a sustainable, well-organized, nationally co-ordinated blood transfusion service, with adequate resources and quality system for all areas;
  • Centralization of blood processing and testing within major centres to permit economies of scale by maximizing utilization of personnel and equipment and uniform standards;
  • Effective and timely testing of all donated blood to ensure maximum safety and availability of blood components;
  • Promotion of appropriate blood component therapy.

Consideration should be given to the use of surplus plasma for the production of plasma-derived medicinal products through fractionation, utilizing facilities either within or outside the country.

WHO publications

Guidance on increasing supplies of plasma-derived medicinal products in low- and middle-income countries through fractionation of domestic plasma

Several plasma-derived medicinal products (PDMPs) are included in the WHO Model List of Essential Medicines, highlighting them as medications considered...

Guidance on centralization of blood donation testing and processing

Multiple barriers to the safety and availability of blood components for transfusion were identified in the 2015 Global Database on Blood Safety, many...

Action framework to advance universal access to safe, effective and quality-assured blood products 2020–2023

In response to calls for action, WHO has provided guidelines, physical standards, training and technical support to improve blood product quality, safety...

Strategic framework for blood safety and availability

Blood transfusion is an essential component of health care that contributes to saving lives and improving the quality of life for millions of people worldwide....

Aide-mémoire for National Health Authorities: safe blood components

Safe blood may be used most effectively if it is divided into components prepared from whole blood donations or obtained by aphaeresis procedures. One...

Meeting reports

1 April 2020

Information Sheet: Ensuring the Quality and Safety of Plasma Derived Medicinal Products

20 March 2012

Assessment criteria for national blood regulatory systems

30 October 2010

WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies

16 September 2006

WHO Guidelines on Tissue infectivity distribution in Transmissible Spongiform Encephalopathies

28 October 2005

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

1 March 2004

WHO Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products, Annex 4, TRS No 924

20 September 1990

Information Sheet: Plasma Contract Fractionation Program

20 September 1990

Aide-mémoire - Blood Products and Related Biologicals