WHO TRS (Technical Report Series) 961, 2011 Annex 4

WHO TRS (Technical Report Series) 961, 2011 Annex 4

WHO guidelines on good manufacturing practices for blood establishments

1. Introduction:

The World Health Organization (WHO) requirements for the collection, processing and quality control of blood, blood components and plasma derivatives (1) define a quality assurance system based on (i) the existence of a national structure that is independent of manufacturers, (ii) compliance with the process of quality assurance for biological products — i.e. control of starting material(s), production processes and final product(s) — and (iii) strict adherence to the principles of good manufacturing practice (GMP). Since the last revision of these requirements in 1992, two relevant items have been reviewed and new recommendations adopted, namely on virus inactivation and removal of plasma derivatives (2004) (2) and human plasma for fractionation (2007) (3). However, a number of issues, such as the requirement for a quality assurance system in blood establishments, have not yet been addressed. The WHO Expert Committee on Biological Standardization (ECBS), therefore, considered that the development of WHO guidelines on GMP for blood establishments is of highest priority in assisting Member States to meet their needs in this area, as requested by the International Conference of Drug Regulatory Authorities in 2008 (4).

The importance of establishing reliable quality assurance systems for the whole chain of blood collection, processing and distribution of blood components in blood establishments was also emphasized by the Sixty third World Health Assembly in resolution WHA63.12 on the availability, safety and quality of blood products (5). In that resolution, quality assurance was seen as a necessary measure that would contribute to increased global availability of plasma that meets internationally recognized standards.

Resolution WHA63.12 recognized that a special effort is needed to strengthen globally the technical capacity of national regulatory authorities (NRAs) to assure the appropriate control of blood products. The resolution recalls earlier related resolutions which urged Member States to promote the full implementation of well organized, nationally coordinated and sustainable blood programmes stressing the role of voluntary, non-remunerated blood donations from low-risk populations.

In recent years, safety and quality in the transfusion chain has become an important topic in many countries and regions (6). Blood establishments should establish and maintain quality systems, based on GMP principles, involving all activities that determine quality policy objectives and responsibilities, and should implement them by such means as quality planning, quality control, quality assurance and quality improvement. A GMP approach to manufacturing safe blood components that consistently meet predefined specifications and customers’ expectations provides a model that allows for a documented system of incorporating quality into the entire process. When collecting and processing blood and plasma from human donors, GMP considerations should be addressed in a biological context due to the specific characteristics of materials of human origin.

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WHO TRS (Technical Report Series) 961, 2011 Annex 4:

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