Authorisation of changes in donation, procurement and collection, processing, preservation, storage and distribution

Objectives
The quality of the preparation of blood, tissues and cells that will be used in a patient has an impact on patients and will condition on the authorization of preparation process steps. Clear quality criteria for different blood components
and tissues and cells types need to be established.
So the WP will be divided in two parts:
The first part will involve the definition of key quality and safety criteria for each category of blood component, tissue or cell. The resulting deliverables will highlight the criteria that need to be validated or verified through in vitro or by clinical studies, and will build on existing work carried out by the Council of Europe (EDQM).
The second part of this WP will develop guidance on how to ensure these criteria are met through in vitro validation, in-process verification or clinical studies.

Description of the Work and Role of Partners
This WP will be led by the National Blood Centre of Lithuania (NBC)
The WP leader will be supported by experts from two other partners from Lithuania, the LUHS Kaunas Clinic and the Santaros Clinic. This team will monitor the progress of the WP6 transversally and vertically, establishing communication with other partners and the co-ordinators of the Joint Action.
Regarding the general organization of the WP this work package will deal with two issues:
Part 1: Definition of the critical characteristics/properties (criteria) for each category of blood component, tissue or cell type (referring to EU blood legislation 2004/33/EC, EDQM blood component monographs and Tissue & Cell guidance). Examples of characteristics/properties might be the vitality of cells following processing, biomechanical strength parameters, a minimum volume, tissue integrity, a minimum number of motile spermatozoa. Where such criteria have already been defined by others, particularly for blood components, the group will review and build on established standards.
Part 2: 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. The guidance will take into account the degree of risk to the patient from the blood component or tissue and cell product based on parameters such as historical data, degree of change in processing or testing. Evidence will include published and laboratory studies conducted by the applying BE/TE criteria identified under Part One and used to determine the depth of validation needed e.g. when the new process has been validated elsewhere, compared to cases where the new process has not been validated before. For reproductive T&C, the validation will take into account long term results regarding the health of the newborn baby. The methods proposed for the demonstration of compliance with the criteria could include in vitro validation studies or in-process verification steps.
The work of Part I will be developed by the organization of three (3) technical meetings for each sub-group. Meetings are going to be held at the same time and place and working groups will work in parallel sessions. During the technical meetings (M 3, M 8, M 13) the working group will determine and further elaborate the scope of characteristics/properties criteria, evaluate existing criteria and methodology, review the existing variety of examples, published studies, etc.
The work of Part II will be developed by the organization of three (3) technical meetings for each sub-group (M18, M.22, M.25). During the technical meetings the working group will study of the depth validation needed, identifying the cases when validation is applicable to the new process; evaluate the draft guidance of the characteristics/properties criteria for each category of blood component, tissues and cells, especially considering proposed changes implementation.
At M27 the closing technical meeting with participants of Part 1 and 2 will take place to agree on the last amendments needed in the definitive version of the guidance documents.
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 preparation processes (authorisation of changes in donation, procurement and collection, processing, preservation, storage and distribution (including labelling and package inserts).

Expected Deliverables
D6.1: Technical Annex on authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution [28]
This deliverable will be the annex on authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution. It will be divided into 3 parts (Blood, tissues, cells and reproductive tissues and cells)

WP6 Leader: Agence de la biomédecine