T/XSMIA 0006-2022 Human cytogenetic resource preservation library management capacity star evaluation system

Scope

Scope: This document sets forth the general principles, evaluation procedures, and supervision and management of the star-rated evaluation of the management capabilities of human cell genetic resource banks. This document is applicable to the evaluation of the management capabilities of human cell genetic resource banks in activities such as the preservation and quality control of cell preparations derived from human tissues; Main technical content: The significance of the star-rated evaluation of the management capabilities of human genetic resource banks: Human genetic resources are an important resource that can be used in biomedical R&D and disease diagnosis and treatment, and play a crucial role in the development of China's biomedical industry. In recent years, with the increasing number of cell banks worldwide, they have become the foundation for the development and preparation of cell preparations and cell therapy, and an important link in the entire cell therapy industry. However, human cell genetic resource banks also face major challenges such as the construction of quality systems, standardization, and management capabilities. In China, a number of different types of cell banks have been established. Among them, the National Stem Cell Resource Bank of the Institute of Zoology, Chinese Academy of Sciences, became the first biospecimen bank in China to obtain ISO 20387 accreditation, and the first stem cell resource bank in the world to be accredited. This has laid a foundation for promoting the standardization and regulation of biospecimen banks in China. However, the standardization of small and medium-sized cell banks in China is relatively lagging behind. Although most of them have management standards, these are only applicable internally, and their construction and management are uneven, lacking unified standards, which makes it difficult to integrate biospecimen resources and hinders the sharing of resources among cell banks. At the same time, some

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