T/SDHCST 003-2022
Specification of Quality management for stem cell-based products (English Version)

Standard No.

T/SDHCST 003-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

Group Standards of the People's Republic of China

Status

Be replaced 2023-07

Replace By

T/SDHCST 003-2023

Latest

T/SDHCST 003-2023

Scope

In order to strengthen industry self-discipline in the quality management of stem cell preparation preparation, avoid contamination, cross-contamination, confusion, errors and other risks in the preparation process of stem cell preparations, and ensure the continuous and stable preparation of stem cell preparations that meet quality standards and intended uses, refer to relevant domestic and foreign regulations and Guidelines for developing this specification

T/SDHCST 003-2022 history

• 2023 T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
• 2022 T/SDHCST 003-2022 Specification of Quality management for stem cell-based products
• 2021 T/SDHCST 003-2021 Standard Practice for Preparation of Human Umbilical Cord/Placental Mesenchymal Stem Cells
• 2019 T/SDHCST 003-2019 CTCs Test Preparation Center Laboratory Regulations
• 2018 T/SDHCST 003-2018 Standards for the Procurement and Distribution of Medicines in Comprehensive-type Township Hospitals