T/CRHA 008-2022 Healthy blood donors' single-nucleated cell resource storage specifications Part 5: Evaluation and release of single-nucleated cell product quality

Scope

Scope: This document specifies the quality standards for the storage of single-nucleated cells and the basic principles for evaluating and releasing them, as well as the process of quality evaluation and release, the content of quality evaluation, and the evaluation conclusions. This document applies to the quality evaluation and release of single-nucleated cells from healthy donors in public banks. Main technical content: The main technical content includes the quality standards for the storage of single-nucleated cells and the basic principles for evaluating and releasing them, the process of quality evaluation and release, the content of quality evaluation, and the evaluation conclusions. The overall structure adopted is as follows: 1) Scope 2) Normative reference documents 3) Terms and definitions 4) Basic principles 5) Process of quality evaluation and release 6) Content of quality evaluation 7) Evaluation conclusions 8) Handling of non-conforming products

Development Information

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