T/QMHIPA 004-2022 Active Group standards

T/QMHIPA 004-2022 Cell preparation center stem cell preparation release inspection specification

Publish Date: 2022-08-15 Implement Date: 2022-08-15 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/QMHIPA 004-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2022-08-15

Implement Date: 2022-08-15

Pages: 19 pages

Scope

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.