This 19th Edition of the Guide to the preparation, use and quality assurance of blood components was elaborated by a dedicated ad hoc working group of experts nominated by the European Committee (Partial Agreement) on Blood Transfusion. These experts are entrusted with the responsibility of updating its text as instructed by the Committee of Ministers of the Council of Europe in Recommendation No. R (95) 15 on the preparation, use and quality assurance of blood components.
This Guide contains an updated version of the Good Practice Guidelines to fully reflect the most recent changes in good manufacturing practices for blood establishments. The Good Practice Guidelines have been jointly developed by the EDQM and the European Commission. In the European Union, the Directive (EU) 2016/1214 requires member states to ensure that blood establishments comply with the Good Practice Guidelines for their quality systems by 15 February 2018.