Guidelines on Management of Blood and Blood Components as Essential Medicines. WHO Expert Committee on Biological Standardization, Sixty-seventh Report; WHO Technical Report Series No. 1004, 2017, Annex 3
(2017; 33 pages)

Abstract

These WHO Guidelines are intended to provide a framework for establishing regulatory oversight of blood and blood components for use in transfusion as EMs. The underlying concept is that blood and blood components are biological therapeutic products of human origin whose preparation should be subject to regulatory standardization and oversight to assure their quality, safety and efficacy. The framework provided in these Guidelines is similar to that which is widely applied to the regulation of drugs produced under current GMP (cGMP) but is adapted to address the specific attributes of blood and blood components for transfusion that distinguish them from PDMPs and from pharmaceutical medicines (drugs) in general. In jurisdictions where the legal frameworks in place for medicines manufactured under cGMP for pharmaceuticals would not apply to blood and blood components, parallel regulation based on the model provided in these Guidelines would involve application of the analogous “GPP” for such products.

The scope of these Guidelines includes elements that:

  • make reference to resolution WHA63.12 (2010) regarding the approach that must be taken to assure the quality, safety and availability of blood and blood components for transfusion (see section 1 above);
  • clarify the specific nature of blood and blood components as biological therapeutic products of human origin (see section 3 below);
  • focus on the ethical aspects of blood donation, such as the need to protect donors against exploitation, and to establish voluntary non-remunerated donations of blood and blood components for transfusion (see section 4.1);
  • recognize the necessity to implement standards and controls, a quality assurance system and good practices for blood and blood component preparation (see sections 4.2 and 4.3);
  • highlight the similarities and differences between blood and blood components and conventional biological medicines and biopharmaceuticals (see section 5);
  • focus on the need to sustain nationally regulated blood systems (see sections 6 and 7).
 
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