Summary and review of collected SOPs from project partners and literature

Task 4.4: Developing standard documents for pre-examination processes for breast milk handling and biobanking activities (M1-M60) (BBMRI, UPPS, UNIGE, CHUT, UOSL, Pfizer). Building a ‘Breast Milk Biobank Analysis Center’ requires a comprehensive quality management approach, to secure and control all operations associated with conducting clinical trials, biobanking activities, and downstream analysis procedures at multiple process levels. The partners will develop the basic structure of this quality management system from a set of applicable European and International Standards for biobanking and pre-analytical sample handling (CEN/TS 16835, ISO 20387, ISO 9001, ISO 20186 etc.) and the guideline for good clinical practice E6 (R2), ICH-GCP for the protection of donor rights and safety. SOPs from the project partners and from the literature will be reviewed to verify key processes and methods. The collection, processing steps, processing times, storage temperature, freeze-thaw-cycles and so forth, will be