Quality Management

The quality of biomaterials is of paramount importance for the success of biomedical research.

Under the umbrella of GBN, we are developing standards and solutions for the next generation of biobanking.


Journals such as “Nature” or “PLOS One” have reported on studies with inadequately characterised or poor-quality biomaterials, which often led to unreproducible research results [Simeon-Dubach et.al., Freedman et.al.]. As a result, numerous projects based on these research results – including those involved in drug development – were unusable and led to enormous time and financial losses.

A high quality of the biomaterials and their associated data is essential to achieve reliable and reproducible scientific results. To ensure this, all sub-processes within a biobank such as acquisition, processing, storage and dispensing of biomaterials must be thoroughly documented to be comprehensible in the long term. A sustainable quality assurance is a basic prerequisite for every biobank, which needs to be guaranteed by an implemented quality management system.

Objectives in the field of quality management:

  • implementation of the QM Manual by the biobanks of the German Biobank Alliance (GBA) and others
  • quality assurance/control: determination of user satisfaction, internal process control, development of a ring trial concept for tissue and liquid biosamples
  • quality assessment programme: development of an internal audit programme, training of internal auditors, implementation of internal audits

Questions?

germanbiobanknode@charite.de

Tel. +49. 30. 450 536 347


Fax +49. 30. 450 753 69 38

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