7.1.3: Other component specifications Other component and process monitoring specifications are detailed later in this chapter. As far as possible, all parameters tested should be deriv…
7.1.1: Leucocyte depletion With very few stated exceptions (e.g. granulocytes), from November 1999 all allogeneic blood components produced in the UK have been subjected to a leucocyte …
6.11: Transportation of blood components 6.11.1: General considerations Donated blood and blood components should be transported by a secure system using transit containers, p…
6.10: Release of components which do not conform to specified requirements Blood and/or blood components may be issued for research, for reagent and, in exceptional cases, for therapeuti…
6.7: Component storage 6.7.1: Specifications for component storage areas Storage areas for blood components must operate within a specified temperature range and should provid…
6.4: Component processing 6.4.1: Premises Component production areas should satisfy the requirements defined in the current Rules and Guidance for Pharmaceutical Manufactur…
6.3: Component and process monitoring tests These guidelines also indicate the minimum level of other process monitoring tests necessary to ensure components are prepared to specificatio…
2.3: Other standards There are a number of other standards that help define how a quality management system should be designed to meet the needs of a particular aspect of a …
2.1: Introduction The key requirements for Blood Establishments and for hospital blood banks are defined in the Blood Safety and Quality Regulations (Statutory Instrument 2005 No. 50) as…
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16.8: Application of HLA testing to patient and donor investigations 16.8.1: Investigation of refractoriness Please refer to the relevant EFI Standards for Transfusion. …
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