WHO Guidelines on Good Manufacturing Practices for Blood Establishments. WHO Technical Report Series 961, 2011, Annex 4
(2011; 67 pages)


The World Health Organization (WHO) requirements for the collection, processing and quality control of blood, blood components and plasma derivatives 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) and human plasma for fractionation (2007). 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.

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