WHO guidelines on good manufacturing practices for blood establishments, Annex 4, TRS No 961

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The document is intended to serve as guidance for both blood establishments and NRAs when implementing and enforcing these principles. It does not address the practice of transfusion medicine or management of emergencies or crises where specific policies defined by the NRA apply. Aspects of personnel and environmental protection are also not within the scope of this document. Complementary guidance, especially with respect to the production of plasma for fractionation, is available in the WHO recommendations for the production, control, and regulation of human plasma for fractionation.