Regulation 15

the biological and functional properties of all cord blood in the licensee’s custody are preserved; and

the risk of contamination of the cord blood is minimised.

the cord blood must be stored in a validated container that is appropriate for its intended use;

every unit of cord blood must be packaged appropriately;

the licensee must maintain and periodically audit the licensee’s inventory system for the cord blood in the licensee’s custody, including all cord blood under quarantine;

the licensee must implement an appropriate labelling system to ensure that every unit of cord blood is correctly identified and traceable from the time of its collection until the time it is distributed;

all cord blood that has been tested and processed must be stored at an appropriate temperature;

the storage requirements (including storage conditions and expiry date) for the cord blood must be appropriate, having regard to —

the packaging and processing requirements for cord blood; and

the intended use of cord blood;

the maximum storage period of the cord blood must be appropriate, having regard to —

the appropriate storage temperature for cord blood;

the packaging and processing requirements for cord blood; and

the intended use of cord blood;

any cord blood that is under quarantine must be clearly labelled and segregated from any cord blood intended for distribution;

where any unit of cord blood is determined to be unsuitable for transplant or other clinical use, the unit of cord blood must be clearly labelled with all of the following:

that the unit of cord blood is unsuitable for transplant or other clinical use;

the purpose for which the unit of cord blood may be distributed, if any.