scope:

This document specifies establishment, expansion, preservation, maintenance, characterization, quality control, storage, distribution and transport requirements for the biobanking of mouse and human pluripotent stem cells. This document is applicable to all organizations performing biobanking with mouse and human pluripotent stem cells used for research and development. This document does not apply to cell lines used for in vivo application in humans, clinical applications or therapeutic use. NOTE - International, national or regional regulations or requirements or multiple of them can also apply to specific topics covered in this document.