T/QMHIPA 004-2022 Active
T/QMHIPA 004-2022 Cell preparation center stem cell preparation release inspection specification
Abstract
Main technical content: This standard applies to all human-derived stem cell preparations, excluding umbilical cord blood hematopoietic stem cell preparations. For cells that do not possess stem cell characteristics, if the preparation, quality inspection, and storage processes are similar to those of stem cells, this standard can be referenced. This standard applies to all institutions and/or departments involved in the preparation, quality inspection, storage, quality control, and clinical research of stem cell preparations. This standard focuses on sample testing and provides unified regulations for the release of stem cell preparations from multiple perspectives, including sample quality management, transportation, personnel, equipment, materials, systems, and environments.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/QMHIPA 004-2022 |
| ICS | Comprehensive Pharmaceutical Science |
| Implement Date | 2022-08-15 |