T/CGCPU 011-2020 Active Group standards

T/CGCPU 011-2020 Quality Control Requirements for Immune Cell Products

T/CGCPU 011-2020

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 011-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Integrated agriculture and forestry

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 Gene vectors 3.3 End-of-production cells 4. Classification of immune cell products 5. Quality control of genetically modified vectors 5.1 Control of raw material residues in vector materials 5.2 Testing of end-of-production cells of vectors 5.3 Detection of exogenous factors in gene vectors 5.4 Quality control standards for viral vectors 6. Requirements for cell donors 7. Quality control of immune cell products 7.1 Detection of cell quantity and cell viability 7.2 Detection of identity, uniformity, and purity 7.3 Detection of biological efficacy 7.4 Detection of process residues 7.5 Detection of tumor cells 7.6 Sterility testing 7.7 Mycoplasma detection 7.8 Pyrogen/endotoxin detection 7.9 Quality control points throughout the entire process 7.10 Storage and transportation of immune cells 7.11 Shelf life of immune cells 7.12 Release standards