T/CQAP 3014-2024 Active
T/CQAP 3014-2024 "Repositories of cellular preparations for anti-tumor clinical studies conducted by researchers and guidelines for quality control" (English translation only)
Abstract
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.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/CQAP 3014-2024 |
| CCS | Basic standards and general methods |
| ICS | Medical microbiology |
| Implement Date | 2024-05-01 |