The
EDQM have issued the 19th Edition of the ‘Guide to the preparation, use and
quality assurance of blood components’ (Blood Guide).
The
19th Edition of the Guide contains an updated version of the Good Practice
Guidelines to fully reflect the most recent changes in good manufacturing
practices relevant for blood establishments. The Good Practice Guidelines have
been jointly developed by the European Directorate for the Quality of Medicines
& HealthCare and the Commission of the European Union. This section of the Guide
describes standards and specifications for the quality system to be implemented
by blood establishments. In the European Union, Directive (EU) 2016/1214,
published in July 2016, requests member states to ensure that blood establishments
comply with the Good Practice Guidelines for their quality system by 15
February 2018.


Posted by Dr. Tim Sandle
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