Quality Assurance and Quality Control in Biobanking

Abstract

An increasing number of biospecimens are being collected in the context of multicenter and international clinical studies and diagnostics. This has revealed the need to optimize management of these biospecimens such that research biorepositories can guarantee that samples distributed to industry or academic researchers are comparable and without institute-dependent intrinsic bias. Acceptance of biological samples and associated data between countries will be facilitated if biobanks can propose validation protocols for their samples and ensure the accuracy of the results obtained from the samples. Certification or accreditation to international standards of the International Standards Organization (ISO) by an independent auditing body provides proof of effective organization, operational consistency and management of the production of “annotated specimens”. Subcontracting to testing laboratories, which are themselves accredited to international standards such as ISO 17025 (General Requirements for the Competence of Testing and Calibration Laboratories) or ISO 15189 (Medical Laboratories—Particular Requirements for Quality and Competence), is proof of reliable sample characterization and production of “qualified specimens”. Despite the fundamental importance of these standards, compliance remains essentially voluntary to each individual biobank. Development of a system of international technical standards for research biobanks is a critical step, currently being addressed in ISO Technical Committee 276 “Biotechnology”.