Page 9 - NewsletterVol2

The next steps will consist of circulating the first findings to new experts during a consolidation

WP6 phase and then, the four subgroups will start working on a guidance to assess the methods
demonstrating that criteria/critical characteristics/properties for each category of SoHO have
been achieved, especially when changes occur in one of the preparation steps.

TECHNICAL ANNEX 2 TO OVERALL GUIDANCE: ASSESSING THE QUALITY AND SAFETY OF DO-
WP7 NOR TESTING, PATHOGEN REDUCTION AND STERILISATION STEPS AS PART OF PPA
WP Leader: ABM, France; FIMEA, Finland

This WP focuses on those technical aspects of processing that aim to reduce the risk of infectious
disease transmission, in particular donor testing, pathogen reduction during processing and
sterilization of final products. The beneficiaries of this WP have achieved the milestone to
agree on a plan of the Deliverable “Technical annex to overall guidance on assessing the
quality and safety of donor/donation testing, pathogen reduction and sterilization steps as
part of PPA”. The Deliverable has been structured into 5 chapters as follows:
• Requirements for selection, validation and performance of donor / donation
infectious marker screening kits, assays and other methods
• Requirements and criteria for laboratories performing donor and blood component/
tissue/cell graft testing
• Criteria for validation of pathogen reduction steps
• Criteria for validation of sterilization processes
• Requirements and criteria for microbiological quality of the final product

Each chapter has been addressed by a specific subgroup composed of beneficiaries,
collaborating organizations and invited experts. The 5 subgroups defined the

general methodological approach and have started drafting the content of the final
document.

TECHNICAL ANNEX 3 TO OVERALL GUIDANCE: ASSESSING CLINICAL DATA AS PART OF PPA
WP8 AUTHORISATION
WP Leader: Finnish Medicines Agency (Fimea; Finland), Barcelona Tissue Bank (Spain)

This WP is aiming to introduce systematic methodologies for the evaluation of clinical data as
part of the authorization of processing activities.

This brochure is part of the joint action ‘785269/GAPP’ which has received funding from the European Union’s GAPP - Newsletter2 9
Health Programme (2014-2020)