Chapter 3

Quality Management System for Research Biobanks: a Tool to Incentivize Public-Private Partnerships

Elena Bravo and Mariarosaria Napolitano


Biospecimens are essential raw materials for the advancement of applied biotechnology. Awareness of the importance of sharing biospecimens has increased in recent years and biobanking activities have facilitated access to them. However, the sharing of such samples for Research & Development could be considerably improved if there were a recognised global agreement about the standard by which to compare their quality. The Organization for Standardization (ISO) is the internationally recognised body that provides guidelines and defines specifications to ensure standardisation of materials, processes and products.The working group two (WG2) of the ISO Technical Committee (TC) 276 established by the ISO on Biotechnology is dedicated to Biobanking. The aim of this working group is to establish sets of standards that apply to the biobanking field, to include human, animal, plant and microorganism samples, thus ensuring that they are of appropriate quality. The availability of worldwide recognized policies and procedures will support access and exchange of samples and related data, giving a major impetus to global use of bioresources for market application. The standard set, which will be based on existing documents and guidelines, will be the foundation of a quality management system (QMS) specifically for biobanking. ISO QMS would enable the establishment of ad hoc global certification that products, processes and/or services conform to relevant standards, technical specifications and guidelines.

Total Pages: 45-67 (23)

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