Assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA
WP7: Technical Annex 2 to overall guidance: assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA
his WP focuses on those technical aspects of processing that aim to reduce the risk of infectious disease transmission,
in particular donor testing, microbial inactivation during processing and sterilization of final products.
The WP will lead to a technical annex that will include an assessment for three kinds of biological products: blood (and blood-derived products), tissue and cells for replacement, haematopoietic stem cells and reproductive tissues and cells. The biological quality and safety parameters will be defined for each step from donation to the application on recipients, which are mainly:
- Donor testing
- Microbial inactivation/sterilisation during product processing
- Evaluation of the microbial status of final products
The safety will be assessed for microbiological pathogens like fungi, viruses and other kind of agents (e.g. prions)
Description of work and role of partners
The work will be developed by teleconferences, emails and during four technical meetings.
During the 1st technical meeting (M2) the working group will be split in subgroups in relation to different tasks (see below) and will define the general methodological approach.
During the further three technical meetings (M8, M14, M20), the working group will focus on the following topics/ chapters of the technical annex:
Assessing and authorising methods related to donor testing, microbial inactivation, microbial status of final products; Requirements for selection, validation and performance of donor infectious marker testing kits and other methods;
Requirements and criteria for laboratories performing donor testing;
Criteria for validation of microbial inactivation steps;
Criteria for validation of sterilisation processes.
Concerning the division of tasks between involved WP leaders and partners:
o ABM will be in charge of the ART field.
o FIMEA will be in charge of the blood field.
o For the Tissue&Cells field: ABM will be in charge of the HSC part, FIMEA of the other Tissues&Cells part.
At M25-26, the 4th final technical meeting will take place in order to agree on the last amendments needed in the definitive version of the deliverable.
Finally as associated partner in this WP and to achieve at best WP9 objectives, PEI will work in parallel in this WP in order to build a data model of information on testing procedures (assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA).
Description of deliverables
D7.1: Technical annex on assessing the quality and safety of donor testing, microbial inactivation and sterilization
steps as part of PPA. (M26)
WP7 Leaders: Agence de la Biomédicine (ABM), France - Laakealan Turvallisuus-JA Kehittamiskeskuss (FIMEA), Finland
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