T/XSMIA 0002-2022 Quality control system specification for integrated cell resource bank

Scope

Scope: This document specifies the management framework for quality control of comprehensive cell banks, the requirements of internal procedures, and the application of data-driven management. This document is applicable to comprehensive cell banks conducting research-grade, clinical-grade, and traceable human umbilical cord mesenchymal stem cell and peripheral blood mononuclear cell raw material collection, cell preparation/separation and extraction, cultivation, quality inspection, cryopreservation, thawing, and external supply activities. Main technical content: The significance of standardizing the quality control system for comprehensive cell banks: Currently, many institutions in China have already launched cell preservation and storage services, but there are still issues such as uneven development of cell storage institutions, disorderly competition, and difficulty in ensuring the quality of cell storage. The healthy development of the cell industry relies on the construction and improvement of standardized and regulated systems. Therefore, establishing a sound quality control system is the foundation for consolidating industry standards. This standard combines various policies, laws, regulations, national standards, industry standards, and group standards to formulate internal standards and establish corresponding data management platforms, providing a systematic explanation of the construction of the cell preservation quality control system for comprehensive cell banks. This document serves as the basis for conducting basic regulatory requirements and supervisory evaluations related to the quality control of comprehensive cell banks. The main content includes six parts: scope, normative referenced documents, terms and definitions, management framework, internal standards, and data management. The content covers the basic regulatory requirements and supervisory evaluations related to the quality control of comprehensive cell banks, including the management

Development Information

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