FSI National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthcare of the Russian Federation.
Klin Lab Diagn. 2020 Sep 16;65(9):587-592. doi: 10.18821/0869-2084-2020-65-9-587-592.
Currently one of the most important problems facing biobanking specialists is the standardization of biobanks operation. Close attention is paid to this issue by international biobanking organizations, such as ISBER and BBMRI-ERIC, which develop regulatory documentation in this area. The article provides examples of standardization tools - implementation of the ISO 9001 quality standard and ISBER Best Practices. General information about the development, scope, and structure of the ISO 20387 standard is provided. The standard does not provide ready-made solutions and does not contain specific requirements for storage temperature or biosamples processing in biobanks, allowing each biobank to adapt its own management system to existing conditions and needs. The standard contains requirements for both the organization of the biobanking and the supporting processes - personnel competence; requirements for biological safety; infrastructure management, including equipment used by the biobank, environmental parameters that affect the storage of biomaterial. The standard contains requirements for the quality management system of biobank, as a necessary element of the organization of any biorepository. At the initiative of the Russian National Association of biobanks and biobanking specialists (NASBIO), development of the Russian standard GOST R ISO 20387 «Biotechnology. Collection and storage of biological samples in biobanks. General requirements» is included in the plan of the National Standardization Program for 2020 by order of Rosstandart No. 2612 of 11/01/2019. Implementing quality standards is a long and painstaking process that requires the involvement of all employees and certain resources. However, the effectiveness of strict compliance exceeds the cost of developing, implementing and maintaining management systems, as it significantly increases the confidence of researchers in the work of biobanks, guarantees high quality of biospecimens and associated data, and creates opportunities for cooperation, both at the national and international level, based on the application of common quality standards in the work.
目前，生物库专家面临的最重要问题之一是生物库操作的标准化。国际生物库组织（如 ISBER 和 BBMRI-ERIC）对此问题给予了密切关注，它们在这一领域制定了监管文件。本文提供了标准化工具的示例——实施 ISO 9001 质量标准和 ISBER 最佳实践。提供了 ISO 20387 标准的开发、范围和结构的一般信息。该标准没有提供现成的解决方案，也没有包含生物库中存储温度或生物样本处理的具体要求，允许每个生物库根据现有条件和需求调整其自身的管理系统。该标准包含对生物库组织和支持流程的要求——人员能力；生物安全要求；基础设施管理，包括生物库使用的设备、影响生物材料储存的环境参数。该标准包含对生物库质量管理体系的要求，这是任何生物库组织的必要要素。在俄罗斯国家生物库协会和生物库专家协会（NASBIO）的倡议下，俄罗斯标准 GOST R ISO 20387“生物技术。生物库中生物样本的收集和储存。一般要求”的制定已被列入 2020 年国家标准计划，该计划由 Rosstandart 于 2019 年 11 月 1 日第 2612 号命令批准。实施质量标准是一个漫长而艰苦的过程，需要所有员工的参与和一定的资源。然而，严格遵守标准的效果超过了开发、实施和维护管理系统的成本，因为它显著提高了研究人员对生物库工作的信心，保证了生物样本和相关数据的高质量，并为合作创造了机会，无论是在国家层面还是国际层面，都基于在工作中应用共同的质量标准。
