Good Practice Guidelines for Blood Establishments as a Co-Operation between the EDQM/CoE and the EU Commission published

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

In November 2013 the European Committee on Blood Transfusion (CD-P-TS) of the Council of Europe adopted the Good Practice Guidelines for Blood Establishments and Hospital Blood Banks Required to Comply with EU Directive 2005/62/EC” during its plenary session. It will replace the "Appendix 1: Interim elements of good practice guidelines for blood establishments and hospital blood banks that are required to comply with EU Directive 2005/62/EC” published in the 17th Edition of the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components.

This document will show the necessary elements of a quality system of blood establishments and hospital blood banks that are required to comply with EU Directive 2005/62/EC. It incorporates

• the “quality system standards and specifications” contained in the Annex of EU Directive 2005/62/EC,
• the quality system Standards and Principles derived from the Guide to the Preparation, Use and Quality Assurance of Blood Components (17th edition) as well as
• quality system elements derived from the detailed principles of GMP (as referred to in Article 47 of EU Directive 2001/83/EC).

Subsequently, the guidelines will become an integral part of the 18th Edition of the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components.

Please see the complete "Good Practice Guidelines for Blood Establishments and Hospital Blood Banks Required to Comply with EU Directive 2005/62/EC" for more detailed information.