T/CQAP 3014-2024 Active Group standards

T/CQAP 3014-2024 "Repositories of cellular preparations for anti-tumor clinical studies conducted by researchers and guidelines for quality control" (English translation only)

Publish Date: 2024-02-01 Implement Date: 2024-05-01 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/CQAP 3014-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Basic standards and general methods

ICS Name: Medical microbiology

Publish Date: 2024-02-01

Implement Date: 2024-05-01

Pages: 28 pages

Scope

This document specifies the classification of cell preparations in researcher-initiated anti-tumor somatic cell clinical studies, the preparation of cell preparations, the quality control requirements for cell preparations, pre-clinical studies of cell preparations, the release quality control requirements for cell preparations, labeling, packaging, transportation, storage, and the handling of non-conforming and surplus cell preparations. This document applies to the preparation and quality control of cell preparations in researcher-initiated anti-tumor somatic cell clinical studies.

Development Information

Word Count: 37 Thousand words Pages: 28 pages

Referenced Standards

GB/T 42076.1-2022 Biotechnology—Cell counting—Part 1:General guidance on cell counting methods SN/T 4835-2017 SN/T 4835-2017 Laboratory Biological Waste Management Requirements 中华人民共和国药典(三、四部)(国家药监局〔2020〕第78号) 细胞治疗产品生产质量管理指南(试行)(国家药监局〔2022〕第4号) 药品生产质量管理规范(中华人民共和国卫生部令〔2011〕第79号)

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