Quality Assurance relative to blood and blood products is increasingly receiving
attention. For that reason the
European Directorate for the Quality of Medicines and HealthCare (EDQM) recently
issued the 14. Edition of the "Guide to the Preparation, Use and Quality
Assurance of Blood Components".
This guide comprises the requirements in the various areas with regard to the
extraction of blood and blood components. Section A covers quality assurance -
chapters 1 through 6 capture the principles of validation and qualification,
instrument control, data systems, recording and statistical process control.
Chapters 7 through 9 in Section B are dedicated to donator selection, extraction
and production of blood components. Chapters 10 through 27 in Section C
extensively cover single blood components, whereas Sections D and E describe
technical processes and transfusion methods.
The guide is the base for many national laws as well as for the European
Commission's blood directives. The 14. Edition was prepared by leading European
experts under the patronage of the European Committee for blood transfusion
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)