EDQM publishes "Guide to the Preparation, Use and Quality Assurance of Blood Components"

GMP News
21 May 2008
 

EDQM publishes "Guide to the Preparation, Use and Quality Assurance of Blood Components"

  
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 (CD-P-TS).

Author:
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)

Source:
http://www.edqm.eu/site/Blood_Transfusion_amp_Organ_Transplantation_Guides-1131.html
 

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