T/XSMIA 0004-2022 Quality management star rating for immunocyte preparation center

Scope

Scope: This document stipulates the general principles for the quality evaluation of immune cell preparations, the sources of raw materials, basic performance, testing methods, and the requirements of the indicator system. This document is applicable to the quality management evaluation activities of immune cell preparation centers. Main technical content: The significance of star-rated quality management evaluation for immune cell preparation centers: With the rapid development of immunology and immunomolecular biology, cell-mediated adoptive immunotherapy has become an important auxiliary treatment method for cancer patients after radiotherapy and chemotherapy. It has achieved good results in promoting the reconstruction of the patient's immune system, eliminating residual tumors, and purifying the bone marrow. However, there is still a lack of specific evaluation standards for the management of immune cell preparation. Therefore, establishing a star-rated quality management evaluation standard for immune cell preparation centers is of great significance for safeguarding human health and promoting the development of related biotherapy technologies and precision medicine. Main content: This document includes nine parts: scope, normative references, terms and definitions, abbreviations, general principles, evaluation indicators, review organizations, application, qualification grade inspection and evaluation. It stipulates the basic principles of the star-rated evaluation system for the quality management capability of immune cell preparation centers, the conditions for review grades, review procedures, evaluation methods, evaluation content, and the requirements for the detailed description of star-rated evaluation indicators and scoring standards for quality management capability. The star-rated evaluation indicators for the quality management of immune cell preparation centers are divided into nine parts: organization and personnel; facilities, environ

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