Regulation 20

the biological and functional properties of all human tissue in the licensee’s custody are preserved; and

the risk of contamination of the human tissue is minimised.

store the human tissue in a validated container;

package all human tissue appropriately;

maintain the licensee’s inventory system for the human tissue in the licensee’s custody, including all human tissue under quarantine;

internally audit the inventory system at appropriate intervals to ensure that the inventory system is accurate;

implement an appropriate labelling system to ensure that each human tissue is correctly identified and traceable from the time of its collection to the time it is distributed;

store all human tissue that has been tested and processed at an appropriate temperature;

ensure that the storage requirements (including storage conditions and expiry date) for the human tissue is appropriate, having regard to —

the type of human tissue concerned;

the requirements in regulation 19 for that type of human tissue; and

the intended use of that human tissue;

ensure that the maximum storage period for every human tissue is appropriate, having regard to the following factors:

the type of human tissue concerned;

the appropriate storage temperature for that type of human tissue;

the requirements in regulation 19 for that type of human tissue;

the intended use for that human tissue;

ensure that any human tissue that is under quarantine is clearly labelled and segregated from any human tissue intended for distribution;

where any human tissue is determined to be unsuitable for transplant or other clinical use, label the human tissue with all of the following:

that the human tissue is unsuitable for transplant or other clinical use;

any other purpose for which the human tissue may be distributed; and

distribute the human tissue only in accordance with the written consent by the donor or authorised person (as the case may be) and the requirements of any other written law.