Regulation 44

the biological and functional properties of each reproductive cell and embryo are preserved; and

the risk of contamination of each reproductive cell and embryo is minimised.

ensure that each reproductive cell and embryo is stored in a validated device that is appropriate for the reproductive cell or embryo and the intended use of the reproductive cell or embryo;

ensure that each reproductive cell and embryo is appropriately packaged and stored;

maintain an inventory system for each reproductive cell and embryo in the licensee’s custody (including those under quarantine);

ensure that an inventory check is performed at least once every 2 years, where the purpose and duration of storage for every reproductive cell and embryo is reviewed to ensure compliance with these Regulations;

implement an appropriate labelling system to ensure that each reproductive cell and embryo is correctly identified and traceable from the time of its collection until the time it is distributed;

ensure that each reproductive cell and embryo that has been tested and processed is stored at an appropriate temperature;

ensure that the storage requirements (including storage conditions) for each reproductive cell and embryo are appropriate, having regard to —

the type of reproductive cell and stage of embryo concerned;

the packaging and processing requirements for the reproductive cell and embryo; and

the intended use of the reproductive cell or embryo;

for any reproductive cell or embryo which is determined to be unsuitable for clinical use — ensure that the container or tank in which the reproductive cell or embryo is stored is clearly labelled with all of the following:

that the reproductive cell or embryo is unsuitable for clinical use;

the purpose for which the reproductive cell or embryo may be distributed;

ensure any reproductive cell or embryo that is under quarantine must be clearly labelled and segregated from any reproductive cell or embryo intended for distribution; and

ensure that a reproductive cell or an embryo that is to be used for a purpose is not stored together with another reproductive cell or embryo that is not to be used for the same purpose.