T/QMHIPA 004-2022
Specification of Release Testing for Stem Cell-based Medicinal Products of Cell Preparation Center (English Version)
- Standard No.
- T/QMHIPA 004-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- Group Standards of the People's Republic of China
- Latest
- T/QMHIPA 004-2022
- Scope
- This specification applies to all human-derived stem cell preparations, excluding umbilical cord blood hematopoietic stem cell preparations. For cells that do not have stem cell characteristics, if the preparation, quality inspection and storage processes are similar to those of stem cells, you can refer to this specification. This specification applies to all institutions and/or departments involved in the preparation, quality inspection, storage, quality control and clinical research of stem cell preparations. This specification focuses on sample inspection and uniformly regulates the release of stem cell preparations from the dimensions of sample quality management, transportation, personnel, equipment, materials, systems, and environment.
T/QMHIPA 004-2022 history
- 2022 T/QMHIPA 004-2022 Specification of Release Testing for Stem Cell-based Medicinal Products of Cell Preparation Center
