ISO 20387:2018 Standard
What is a Biobank ?
A Biobank is a depository for biomaterials from a representative portion of a human population.
The Biobank acts as a vault with intricate detailed information pertaining to the individuals from whom
biological materials have been collected.
Data collection and proper cataloging cataloging are essential components for the success of a Biobank
Types of Biobanks :
- Tissue bank – (i) Surgical tissues (ii) Transplant tissues
- Cancer / Tumor bank
- Cord blood / Stem cell bank
- Blood bank – Dried Blood Spots
- Body fluids – (i) Synovial (ii) Urine (iii) Sputum (iv) Buccal scrapings (v) Sperm
- DNA / RNA bank
- Cornea bank
Utilities of Biobanks :
Routine work – health centers, hospitals, blood transfusion centers and Public / Private pathological laboratories.
Research work – biomedical experiments for a particular disease in a specific population.
Epidemiological work – monitoring in susceptible populations after disease outbreak, poisoning and / or pollution
About the International Standard :
ISO has released an Accreditation Standard – ISO 20387:2018 for Biobanks. This Standard was developed to promote confidence in biobanks. The standard covers requirements that allow biobanks to demonstrate their competence in being able to provide biological material and associated data that meets the needs of research and development organisations.
A biobank is a biorepository that accepts, processes, stores and distributes biological material and associated data for use in research and clinical care. This biological material can come from human, animal or plant sources.
The accreditation process will cover collection (or acquisition), reservation, quality control, storage and distribution of biological material. It will also include a review of the management system underpinning these processes.
Biobanks, which hold hundreds of millions of biological samples – including those from humans, animals, plants, and microbes – help the global scientific community further everything from crop production to personalized medicine. Biobanks vary widely in terms of the kinds of biological material they hold, the activities they undertake, the services they provide, and their geographical location, size, and structure.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
Why Accreditation of Biobanks needed ?
Businesses seek Certifications or Accreditations to various Quality Management Systems programs on Voluntary basis to demonstrate their conformance to Quality and Safety Management Systems. Sometimes these Certifications or Accreditations become mandatory when these are regulated by Regulators in the country.
Biotech is an emerging sector in India and this segment is witnessing fastest growth in the last one decade in the country. We have mushroom growth of Startups, young businesses and growth stage businesses in biotech sector. Many ventures are related to R&D domain too.
Biobanks have been steadily growing in the country and infact 15-20 years ago , many Cord Stemcell Banks were asking for specific Certifications, Accreditations related to their domain. We had only ISO 9001:2008 Std way back then and we were offering ISO 15189:2007 for testing related requirements of these banks. Some centers opted for AABB Accreditation from USA. Apart from these, there was no specific standard available for biobanks.
ISO has released an exclusive Standard for Biobanks now and this is an Accredtitation Standard developed exclusively for Biobanks. Bioresearch will attract lot of attention globally now and bio based organisations need to have effective Quality Management Systems in place to demonstrate their process and systems efficiencies, technical competencies on an ongoing basis.
Who is offering Accreditation for this Standard in India ?
Quality and Accreditation Institute is offering Accreditation to Biobanks in the country.
QAI is organising an Implementors Program on the standard and the details are as follows :
Source : http://www.qai.org.in/