The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across Europe. The document follows on from the European Conference on “Sharing best practices: Quality Risk Management, Change Control, Validation and Qualification in Blood Establishments”, held by the EDQM in October 2017 in Strasbourg. These recommendations provide clear guidance for the future technical and regulatory landscape of blood transfusion in Europe from a quality perspective.
With speakers representing the major stakeholders in the sector — competent authorities, inspection bodies, blood establishments and suppliers — the event attracted participants from all over Europe to reflect on current regulatory requirements and discuss QMS best practices, current and future. The 36 speakers presented their know-how and practical experience in the field of qualification, validation, change management and risk management followed by a series of dedicated, practical workshops. With 34 countries present at the event, precedence was given to clarifying these concepts and their interpretation, discussing their practical implementation and shedding light on the roles and responsibilities of the different interested parties. The set of recommendations that ensued from these exchanges constitute a best practices roadmap to assist all stakeholders, from the major influential organisations active in the field (the European Commission, EDQM and European Blood Alliance) to the national authorities, BEs and suppliers of equipment and devices, in their efforts to develop and implement cost-effective and sustainable QMSs.
- The press release can be accessed here.
- The Proceedings of the conference may be downloaded through the free publications management tool of the EDQM here under the section Blood transfusion "Sharing best practices: quality risk management, change control, validation and qualification in blood establishments. Conference proceedings, 17-19 October 2017".