News about GMP/cGMP


EDQM: 21st Edition of the Blood Guide Published

EDQM: 21st Edition of the Blood Guide Published

The European Directorate for the Quality of Medicines & HealthCare (EDQM) published the 21st edition of the Guideline for the Preparation, Use, and Quality Assurance of Blood Components earlier this month. As a compendium of widely accepted, harmonised European technical standards the guide should provide safety, efficacy, and quality requirements for the preparation, use, and quality control of blood components in Europe and beyond.

It is compiled for all professionals working with blood and blood components and offers an overview of the most recent advances in the blood field, together with guidance concerning blood donation and collection.

The Blood Guide also includes the Good Practice Guidelines (GPGs) which provide standards for the implementation of quality systems in blood establishments and, where applicable, hospital blood banks. Under European Commission Directive (EU) 2016/1214, the GPGs should be considered by EU member states in the implementation of quality systems in their blood establishments.

The latest edition introduces documentation of all changes compared to the previous version in a change log. Furthermore, the terminology has been standardised, harmonising, in particular, the use of the terms “must” and “should” in the guide, and inclusive language has been introduced.

A free version of the guide and the change log can be downloaded here.


EDQM: Newsroom