Page 7 - GAPP Newsletter Issue 1 Jan2019

Technical Annex 1 to overall guidance: authorisation of changes in donation, procurement
WP6 and collection, processing, preservation, storage and distribution (including labelling and

package inserts): WP 6 is a very technical WP which involves a consistent list of associated and
collaborating partners. It covers the overall duration of the action. The work of this WP is di-
vided in two parts: Part 1 will develop definition of the critical characteristics/properties (crite-
ria) for each category of blood component, tissue or cell type (referring to EU blood legislation
2004/33/EU, EDQM) blood component monograph and T&C guide.
Part 2 will develop a Guidance on the assessment of methods to demonstrate achievement/
maintenance of the critical characteristics/properties for each category of SoHO, in particular
where changes are proposed/implemented in one of the preparation steps.

Technical Annex 2 to overall guidance: assessing the quality and safety of donor testing, mi-
WP7 crobial inactivation and sterilisation steps as part of PPA (ABM, France; FIMEA, Finland): This

WP focuses on those technical aspects of processing that aim to reduce the risk of microbial
contamination, in particular: donor testing, microbial inactivation during processing, steriliza-
tion of final products. The Technical Annex produced by this WP will include an assessment
for four kinds of biological products: blood (and blood-derived products), tissues and cells for
replacement, haematopoietic stem cells, reproductive tissues and cells. A technical group will
define the shape of the document in order to harmonise whenever possible the text. Three
Technical Meetings will be organised and the work will be also conducted via teleconferences.
Council of Europe is involved in the work of the WP and also ESHRE was invited as collaborat-
ing experts.

Technical Annex 3 to overall guidance: assessing clinical data as part of PPA authorisation
WP8 (FIMEA, Finland and BST, Spain): WP 8 aims at introducing systematic methodologies for the

evaluation of clinical (and technical) data, as part of the authorisation of processing activities.
The content of previous project will be taken into account by WP 8. This workpackage aims to
achieve common practices and systematic methodologies for the evaluation of clinical (and
technical) data as part of the authorisation of processing activities. It was agreed that the first
Technical Meeting will be organised jointly with other WPs.

Knowledge sharing on PPA between EU CAs (PEI, Germany): Dorothea Stahl presented WP9

WP9 on behalf of PEI. PEI is responsible for the authorisation of biomedicine, tissue preparation,
tissue engineering and transfusion medicine.
The aim of this WP is to lay the grounds for a future implementation of the criteria catalogue
resulting from WP 6-8 to allow for a standardised, electronically supported assessment of
quality, safety and efficacy of blood, cells and tissues, in the case of state-of-the-art process-
ing procedures as well as in the case of innovative processing procedures.

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“This newsletter is part of the joint action ‘785269/GAPP’ which has received funding from the European Union’s Health Programme (2014- GAPP - Newsletter 1 7
2020). The content of this New-sletter represents the views of the author only and is his/her sole responsibility; it cannot be considered to
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