Since December 2018, a total of 13 “friendly audits” have been conducted at biobanks of the German Biobank Alliance (GBA). All of the partner biobanks involved in the alliance since 2017 have thus now been audited once. During the Europe Biobank Week in Lübeck, the former director of the French network BIOBANQUES Georges Dagher praised the concept: “I congratulate the German Biobank Node on this excellent internal auditing system, which is unprecedented in Europe and should be used by other countries as a model. It allows the adequate quality of samples and related data to better be ensured.”
“Friendly audits” prepare biobanks for accreditation
The ISO standard “Biotechnology – Biobanking – General requirements for biobanking” was published in 2018 and, since 1 September 2019, it has been possible to apply to the German national accreditation body (DAkkS) for accreditation. “In my opinion, GBA’s ‘friendly audits’ are the perfect preparation for accreditation in accordance with the ISO 20387 standard for biobanking. The auditors provided valuable information and made concrete suggestions on where changes to our processes would make sense. They were very competent and their ‘view from the outside’ opened up new perspectives for us,” commented Prof. Dr. Christian Brandts, who is head of the Interdisciplinary Biomaterial Bank and Database Frankfurt (iBDF) and deputy spokesperson for the network of comprehensive cancer centres (CCC). A second round of “friendly audits” will begin in December with auditing of a partner biobank that first become a GBA partner in 2019.
Auditor qualification
A total of 23 auditors are now available for the second round of audits – 15 GBA employees were qualified during a training course held in Frankfurt am Main in November in cooperation with TÜV Süd. Prerequisites for this role are several years of professional experience in biobanking and knowledge of quality management.
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