Euro GTP Guidance - Euro GTPs

A.2.3. FACILITIES, EQUIPMENT AND MATERIALS FOR STORING
1. The devices intended for storage should be located preferably in a separate area to which
access is controlled and restricted to authorized persons.
2. A temperature monitoring system should be utilized to document temperatures and to alert
staff when temperatures have strayed outside acceptable limits. Procedures should be in
place for reviewing temperatures. If storage utilizes liquid nitrogen, either liquid nitrogen
levels or temperature should be monitored and documented at an interval specified in the
SOP.
A.3. DONOR SCREENING
1. Both generic and specific GTPs should include requirements related to donor selection and
evaluation, risk assessment, validation methodologies, documentation, premises, personnel
and quality management.
2. The major objective of the chapter on the donor screening process is to protect the final
tissue recipient. Safety and quality of the human tissue depends, to a large extent, on the
ability to identify true positive risks and avoid false positive risks.
3. According to EU Directive 2006/17/EC, Articles 3 and 4 ‘Selection criteria for donors are
based on an analysis of the risks related to the application of the specific cells/tissues.
Indicators of these risks should be identified by physical examination, review of the medical
and behavioural history, biological testing, post-mortem examination (for deceased donors)
and any other appropriate investigation.’ Outlines for physical examination are described
elsewhere in this Guide, whereas the other criteria could be defined as the process of donor
screening. The purpose of screening a donor is to collect information, to assess the data on
critical points of safety, quality and unique identification, and to evaluate this information in
relation to relevant aspects of the tissue, in order to determine whether or not to release
tissues for transplantation purposes
4. This chapter aims to provide tools to carry out the screening test in the best way so as to
ensure the quality of the tissue and the safety of transplant recipients. The scope of this
chapter covers the steps between donor detection and donor release for further processing.
A.3.1. ACTIVITIES
A.3.1.1. Donor detection
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