Wroclaw Medical University, as a member of the BBMRI.pl consortium, is responsible for the task “Verification of SOPs that exist in Polish biobanking institutions, implementation of common solutions”, as part of the project “Creating the Network of Biobanks in Poland, within Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC”, funded by the Ministry of Science and Higher Education.
According to the task guidelines, the recognition and analysis of quality assurance and management systems as well as ethical and legal aspects in Poland related to biobanking of biological material intended for research and development were carried out. One of the main tasks is to develop, for the Polish Biobanking Network (PBN), the concept of Quality Standards for Polish Biobanks (QSPB) and the Auditor’s Manual Handbook (AMH).
Members of the BBMRI.pl Consortium belong to BBMRI-ERIC working groups, associating representatives of member countries, whose responsibility is to obtain common solutions in the field of IT, QMS, Audit Programmes and ELSI. Through such wide cooperation, both the Quality Standards (QSPB) and the manual for the auditor (AMH), are convergent with European law, as well as with global ISO standards. QSPB are consistent with the provisions of the Taipei Declaration, OECD recommendations, IARC/WHO guidelines (International Agency for Research on Cancer/World Health Organization) and ISO standards: 9001, 20387, 15189, 17025, 14001; CEN / TS 16826-1, 16826-2, 16827-1, 16827-2, 16827-3, 16835-1, 16835-2, 16835-3, 16945.
Quality Standards for Polish Biobanks (QSPB) include with their requirements 15 different areas: (1) Organization / institution management; (2) Quality Management; (3) Documentation and records; (4) Human Resource Management; (5) Ethical and legal aspects; (6) Supplies, materials management; (7) Devices; (8) Traceability; (9) Environmental and staff hygiene; (10) Technological Processes and quality control; (11) Deviations, incompatible product/data or service; (12) Audits; (13) Improvement; (14) Scientific cooperation; (15) Safety.
What makes the QSPB different is the unique structure, containing guidelines, good practices and frequently asked questions (FAQs) to help the understanding of regulation and better implementation of the guidelines by the biobanks.
The Handbook for the Auditor (AMH) is the supplement to the QSPB, which at the same time can be used as a tool enabling biobanks to carry out an internal audit of each process to which the QSPB guidelines have been provided. The AMH form allows it to make records during audits and may constitute a report from the performed audit.
The implementation of QSPB allows biobanks to provide high-quality services and will improve the overall effects of the institution. The implementation of the QSPB guidelines will secure the collected biological material along with data and guarantee the appropriate quality.
Potential benefits of implementing QSPB for biobanking institutions is the ability to ensure the delivery of products and services that consistently meets the accepted internal, legal and third-party requirements. It also provides adequate resources for processes and proper management, as well as consideration of opportunities for improvement. QSPB provide a real opportunity for certification by biobanks for the QMS for compliance with the ISO 9001 standard and accreditation in the scope of the ISO 20387 standard.
QSPB and AMH in May 2019 will be presented to BBMRI-ERIC Members and will be subject of evaluation by members of Working Groups (WG) BBMRI-ERIC:
(1) chapter 5 – The ELSI Group
(2) chapter 15 – IT and QMS Group
(3) other chapters Group QMS.