Division B Documentation relating to the third country supplier or suppliers

A detailed description of the criteria used for donor identification and evaluation, information provided to the donor or donor family, how consent is obtained from the donor or donor family and whether the donation was voluntary and unpaid or not;

Detailed information on the testing centre(s) used by third country suppliers and the tests performed by such centres;

Detailed information on the methods used during the processing of the tissues and cells including details of the validation for the critical processing procedure;

A detailed description of the facilities, critical equipment and materials and criteria used for quality control and control of the environment for each activity carried out by the third country supplier;

Detailed information on the conditions for release of tissues and cells by the third country supplier or suppliers;

Details of any sub-contractors used by the third country suppliers including the name, location and activity undertaken;

A summary of the most recent inspection of the third country supplier by the third country competent authority or authorities including the date of the inspection, type of inspection and main conclusions;

A summary of the most recent audit of the third country supplier carried out by, or on behalf of, the importing tissue establishment;

Any relevant national or international accreditation.