The standard stipulates the model specifications, performance indicators, and inspection methods of 7 components and 12 specifications of disposable fully enclosed consumables for autologous cell culture, sampling, and harvesting during the preparation of CAR-T immune cell products. The content of the standard mainly includes normative cited documents and reference documents, terms and definitions, basic requirements, process control, document management, testing and verification.
T/CECCEDA 002-2023 history
2023T/CECCEDA 002-2023 Manufacture practice of single-use materials in CAR-T production
2022T/CECCEDA 002-2022 General Requirements for professional technical competence of corporate compliance practitioners