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.Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
