T/XSMIA 0003-2022 Cell preparation center management capacity star rating

Scope

Scope: This document stipulates the basic principles of the star rating evaluation system for the management capabilities of cell preparation centers; the review grade conditions; and the review procedures, including evaluation methods, evaluation content, and requirements for the detailed breakdown and weight distribution of star rating evaluation indicators for management capabilities. This document applies to the star rating evaluation of the management capabilities of cell preparation centers and can also be used for self-evaluation by cell preparation centers. Main technical content: This document stipulates the basic principles of the star rating evaluation system for the management capabilities of cell preparation centers, the review grade conditions, and the review procedures, including evaluation methods, evaluation content, and requirements for the detailed breakdown and scoring standards of star rating evaluation indicators for management capabilities. The evaluation standards are formulated in accordance with various policies, laws, regulations, national standards, industry standards, and cell preparation center construction and management norms. Through a comprehensive evaluation of the basic standards, organizational management, facility and environmental management, equipment management, material management, production and quality control management, biosafety management, and file management of cell preparation centers in the form of a thousand-point assessment, corresponding scores are assigned. Evaluation standards and scoring standards are set up in major aspects such as institutional setup, life ethics, personnel management, cell preparation center design, and management requirements, and detailed requirements are specified for environmental parameters, equipment, materials, cell product production, transportation, cell product testing management, and quality control. This is aimed at promoting the healthy development of the biomedical industr

Development Information

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