T/CQAP 3015-2025 Active Group standards

T/CQAP 3015-2025 The production and quality control specifications for mesenchymal stem cell drugs

Publish Date: 2025-07-10 Implement Date: 2025-11-10 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/CQAP 3015-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Biological products and blood products

ICS Name: Drugs

Publish Date: 2025-07-10

Implement Date: 2025-11-10

Scope

Main technical content: It stipulates the general requirements for the production and quality control of human mesenchymal stem cells (hMSC) drugs, including personnel and training, plant facilities and equipment, production materials, target product quality overview, production processes, quality control, stability studies, labeling, instructions, packaging, transportation and storage, quality risk management, quality assurance, and continuous improvement. It applies to the production and quality control of allogeneic hMSC drugs in the registration clinical trial and commercialization stages. Autologous hMSC products and hMSC products that have undergone gene editing or modification can refer to the relevant content of this document after evaluation based on the product characteristics.