Standards for Hematopoietic Progenitor Cell and Cellular Product Services

Covers requirements for consistency with FDA's proposed good tissue practice regulations, requirements for interface between collecting and administering facilities, donor qualification requirements, processing tests and record retention timeframes consistent with GTP requirements.

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This 3rd edition has been broadened in its name and scope with the addition of cellular products. Other key revisions include revised requirements for consistency with FDA's proposed good tissue practice regulations, new requirements for interface between collecting and administering facilities, revised donor qualification requirements, new processing tests and new record retention timeframes consistent with proposed GTP requirements.