What is it? Why is it important?
Biobank owners responsible for the set-up and management of biobanks can apply for SBP Quality Labels (SBP Labels). Labels confirm the quality of biobanking processes and as a result the quality of its Biological Material (BM).
SBP Labels are awarded based on proven compliance with a given set of criteria. SBP Labels include a:
- VITA Label: confirms compliance with ethics and legal requirements
- NORMA Label: confirms compliance with standardized operational biobanking processes
- OPTIMA Label: confirms compliance with defined quality management standards and the implementation of quality assurance measures
The SBP Labels align with international ISO standards on Biobanking (ISO 20387).
What do I need to do?
To apply for a SBP Label:
- Register your biobank in the Biobank SQAN online tool
- Fill in the online questionnaire to reflect the operational processes of your biobank (e.g. 250 questions addressing biobanking governance, resources, processes, and quality assurance)
The SBP evaluates:
- Information provided from the online questionnaire
- Potentially requested biobanking documents
- Information gathered during biobanking on-site visit(s) (e.g. only required for NORMA and OPTIMA QL)
During quality evaluations the SBP also provides active support to researchers (e.g. documents needed to cover for identified gaps).
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic - see in particular
- SBP Labels: Quality with biobanking best practice standards
- SBP-SQAN – Biobank for Solution Quality assessment and normalization
- Quality Manual
SOPs, Forms and Templates – see in particular
- Improvement Management SOP