20th edition of the guide to the preparation use and quality assurance of blood components
The Guide to the preparation, use and quality assurance of blood components, also known as the Blood Guide, provides a compendium of widely accepted European harmonised standards for the preparation, use and quality control of blood components to provide safety, efficacy and quality requirements for blood components in Europe and beyond.
The Blood Guide is regularly updated by the European Committee on Blood Transfusion (CD-P-TS), an intergovernmental committee, which has, according to Resolution CM/Res(2011)24, entrusted a subordinate body, the GTS ad hoc Working Group TS Guide (GTS), with the revision of the guide.
This edition introduces a major change in the organisation of the Blood Guide. The pre-existing “Principles” and “Standards” sections have been merged to facilitate its use, as standards are now better identified.
Organisation of chapters
The Good Practice Guidelines (GPGs) chapter fully reflects the most recent changes in good manufacturing practices relevant for blood establishments. The GPGs were prepared through ad hoc co-operation between the EDQM and the European Union Commission. The GPGs are mandatory requirements within the European Union as per Directive (EU) 2016/1214. “Standards” in the chapters aim to support safety and quality requirements for transfusion practices in Europe and beyond. The “Monographs” chapter describes requirements that are to be regarded as harmonised standards for the quality and safety of blood components across Europe.
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