T/CGCPU 010-2020 Active Group standards

T/CGCPU 010-2020 Immune cell product preparation environment 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 010-2020

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 Clean area 4. Design principles for immune cell product preparation facilities 5. Environmental requirements for immune cell product preparation 6. Design requirements for clean areas 7. Construction requirements for clean areas 8. Design and construction requirements for storage areas 9. Design and construction requirements for quality control areas 10. Design and construction requirements for auxiliary areas 11. Equipment