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.

Concept

Harmonisation/improvement

Using the German Biobank Node's QM handbook as guideline, all GBA sites are implementing a uniform and productive quality management system. To this end, various support options are available: (i) provision of quality management documents as a template for in-house biobank processes as well as (ii) workshops (iii) personal advice to support practical implementation and (iv) a uniform QM software for biobanks.

The members of the QM core team are intensively involved in national and internaional working groups of DIN and ISO. They inform the GBA community regularly on this subject.

Quality Assurance/Control

The quality concept comprises:

  • internal process control
  • ring trials
  • determination of user satisfaction

During ring trials, biomaterial samples are sent from reference laboratories to the participating biobanks. Upon arrival, the biosamples are processed according to the respective operating procedures of the biobank, starting with the reception to the storage of the samples. After a defined storage time, the prepared samples are sent to a reference laboratory in order to analyse the sample for various parameters.

This approach allows an evaluation of the process quality (by determining the sample quality) starting from sample reception and storage through to production and measurement of derivatives.

By means of a literature review, pre-analytical quality biomarkers are identified that are to be analysed in a GBA biobank. Considering the entire process chains, these are evaluated in relation to quality targets to generate “key figures” from them. These should contribute to the monitoring, and if necessary, improvement of the processes.

Quality Assessment Programme

To establish a comprehensive GBA audit programme, experts from the consortium and other biobanks will be recruited and trained as auditors first of all. Subsequently, an audit programme will be developed according to DIN EN ISO 19011. The GBA biobanks will initially establish an internal audit programme, in order to evaluate and continuously improve processes within the alliance of biobank partners.

In the further course of the project, a programme for external audits will be developed together with the national accreditation body (DAkkS) based on the future biobank standard. In cooperation with BBMRI-ERIC, this procedure shall also serve as a foundation for planned auditing activities in Europe.

Questions?

germanbiobanknode@charite.de

Tel. +49. 30. 450 536 347


Fax +49. 30. 450 753 69 38

BMBF
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