This standard specifies the requirements for quality control, test methods, inspection rules, and storage requirements in the preparation process of stem cell products; it mainly provides guidance on preventing the introduction of pathogenic microorganisms during the complete process of cells from storage, freezing, cryopreservation to delivery. and dissemination; risk control measures, requirements and suggestions to avoid contamination, cross-contamination, confusion, errors and other risks, aiming to ensure that the quality management of cell banks meets the intended uses and requirements, and to maintain the biological effectiveness and functions of cell products. This standard applies to the quality management practices of cell banks and the preparation process of stem cell products.
T/SDHCST 003-2021 history
2023T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
2022T/SDHCST 003-2022 Specification of Quality management for stem cell-based products
2021T/SDHCST 003-2021 Standard Practice for Preparation of Human Umbilical Cord/Placental Mesenchymal Stem Cells
2019T/SDHCST 003-2019 CTCs Test Preparation Center Laboratory Regulations
2018T/SDHCST 003-2018 Standards for the Procurement and Distribution of Medicines in Comprehensive-type Township Hospitals