Wednesday, 14 June 2017

Guide to the preparation, use and quality assurance of blood components (new version)

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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