Page 6 - INTERIM NEWSLETTER FINAL

The work of WP6 was divided in two parts:

Part 1 is focused on the Definition of the critical characteristics/properties for each category of
blood components and tissues and cells. It will also highlight the criteria that need to be validated

or verified through in vitro or by clinical studies (build on existing CoE EDQM, EU Blood legislation
2004/33/EC)
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Part 2 is focused on defining Guidance on how to ensure these criteria are met through in vitro
validation, in-process verification or clinical studies. (Assessment of new procedure’s validations
by using published studies and of laboratory studies conducted by the applying BE/TE as part of
their validation, depth of validation for procedures already validated elsewhere, depth of
validation for procedures not validated anywhere before).

The overall work in WP6 was divided in four subgroups: the one for BLOOD led by Imad Sandid

(ANSM), MAR by Dominique Royere (ABM), TISSUES by Isabelle Martinache (ABM) and CELLS by
Eoin McGrath (JACIE/EBMT).

This report is part of the project/joint action ‘785269/GAPP’ which has received funding from the European Union’s Health Programme (2014-2020). The content of this report represents the views of
the author only and is his/her sole responsibility; it can not be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any
other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.
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