T/CGCPU 009-2020 Active Group standards

T/CGCPU 009-2020 Immune cell product preparation process control requirements

Publish Date: 2020-09-30 Implement Date: 2020-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CGCPU 009-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2020-09-30

Implement Date: 2020-10-01

Scope

Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 3.1 Immune cell products 3.2 Donors 3.3 Release 3.4 Clean area 3.5 End-of-production cells 3.6 Identity verification and traceability chain (cCOI) 4. General principles for the preparation of immune cell products 5. Key control points in the preparation process of immune cell products 6. Operational requirements during the preparation process 7. Material requirements 8. Product packaging requirements 9. Storage and transportation requirements 10. Label management 11. Hygiene control during the preparation process 12. Management of preparation tools 13. Management of disinfectants 14. Management of culture media 15. Sterilization management 16. Inspection requirements 17. Handling of contaminants