Good practices for blood establishments

Preface

Blood transfusion is a vital component of modern health care and can be life-saving in many clinical situations. However,
it is not without risks, including the potential for acute or delayed complications and the transmission of infections. Plasma – the liquid portion of blood – is less commonly used for direct transfusion and is often discarded despite its value. Rich in essential proteins, plasma can be fractionated on an industrial scale to produce plasma-derived medicinal products such as factor VIII, factor IX, fibrinogen, immunoglobulins and albumin. These products are crucial in the treatment of bleeding disorders, immune deficiencies, certain infections and other serious health conditions. Therefore, ensuring the safety and quality of both transfused blood components and plasma used in pharmaceutical manufacturing is of paramount importance. The preparation of blood and blood components for transfusion – including collection, testing, processing, storage, release and distribution – is carried out by blood establishments. These responsibilities also extend to plasma intended for further industrial processing. To safeguard the quality and safety of these products, blood establishments must implement and maintain quality systems based on good manufacturing practices (GMP). The importance of such quality assurance systems has been recognized by the World Health Assembly in resolution WHA63.12, which emphasizes the role of robust quality systems in increasing the global availability of safe, high-quality blood components, and in ensuring the production of plasma for further processing that meets internationally accepted standards.
In response to this recognized need, the WHO guidelines on good manufacturing practices for blood establishments were published in 2011. These guidelines were endorsed by the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) and by the Expert Committee on Biological Standardization (ECBS), and published as Annex 4 of the WHO Technical Report Series No. 961.

However, the 2011 guidelines did not fully address the specific requirements for generating plasma suitable for further processing. The document also preceded a number of recent advances, such as new screening tests for transfusion-transmissible infectious agents, use of automation in blood testing, pathogen inactivation technologies, and developments in apheresis for blood and plasma collection. Additionally, there is a growing need to align WHO
guidance with other international standards to support harmonization and facilitate the global manufacturing and
use of safe and effective plasma-derived products. 

The current updated and renamed document has been aligned with the key strategic objective of the WHO Action framework to advance universal access to safe, effective and quality-assured blood products 2020–2023, namely the establishment of functioning and efficiently managed blood services, including through the implementation of a
comprehensive quality system across the entire blood transfusion chain. This guidance has been endorsed by both
ECSPP and ECBS. It has been published as Annex 4 of the WHO Technical Report Series 1060 (58th report of ECSPP) and as Annex 4 of the WHO Technical Report Series 1063 (80th report of the WHO ECBS).

Guidance documents published by WHO are intended to be scientific and advisory in nature. This document provides guidance to blood establishment managers and staff on ensuring the quality, safety and efficacy of blood and blood components for transfusion and plasma for further industrial fractionation. The good practices described in each section of this document could also be used as the basis of inspections by the national regulatory authority (NRA) and may, if an NRA so desires, be adopted as definitive national requirements, or modifications may be justified and made by the NRA. It is recommended that such modifications be made only on condition that such modifications ensure that blood and blood components are at least as safe and efficacious as those prepared in accordance with the good practices and associated further guidance provided in the current document.