Published August 17, 2021 | Version v1
Project deliverable Open

Description of basic quality management structure for biobanking and pre-analytical handling of human breast milk specimens (D4.4)

  • 1. BBMRI-ERIC

Description

This deliverable provides an overview of the basic structure of the Quality Management System (QMS) aligned with a set of applicable European and International Standards for biobanking and pre-analytical sample handling and the guideline for Good Clinical Practice E6 (R2), ICH-GCP for the protection of donor rights and safety. Such a system is necessary at the breast milk biobank and analysis centre in Uppsala in order to obtain high-quality samples and associated data.

Files

821520_ConcePTION - D4.4 Description of basic quality management structure for biobanking and pre-analytical handling of human breast milk specimens.pdf

Additional details

Funding

ConcePTION – Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation 821520
European Commission