Euro GTP Guidance - Euro GTPs

tissue and cell procurement. The appropriate equipment and instruments should be used, in
order to guarantee the quality of the specific recovered tissue.
2. Wherever possible, only CE marked medical devices must be used and all concerned staff
must have received appropriate training on the use of such devices.
3. Sterile instruments and devices must be used for tissue and cell procurement. Instruments
or devices must be of good quality, validated or specifically certified and regularly
maintained for the procurement of tissues and cells.
4. When reusable instruments must be used, a validated cleaning and sterilisation procedure
for removal of infectious agents should be in place. 9
5. The TE or ORHA must have equipment adapted to the operations for which they are
intended, in accordance with the requirements of this general quality standard and in
accordance with the standard specific for each tissue type.
6. Measuring, recording and control equipment should be calibrated and checked at defined
intervals by appropriate methods. Adequate records of such tests should be maintained. The
parameters affecting the quality or safety of tissues and cells (e.g. temperature, pressure,
particle count) are defined, monitored and recorded. When appropriate, the equipment will
be provided with an alarm system.
7. Premises should be carefully maintained, ensuring that repair and maintenance operations
do not present any hazard to the donors. They should be cleaned and, where applicable,
disinfected according to detailed SOPs. They will be inspected regularly and maintenance
will be performed according to manufacturer's instructions and / or to the specifications
established by the TE or ORHA.
8. After any major repair or modification, the equipment or critical equipment should be rechecked
and validated before its release.
9. Calibration and maintenance operations should be carried out according to written
procedures and scheduled on an annual basis. Temperature should be monitored with
calibrated probes to ensure that during the entire period of time the range has been properly
kept.
10. If there is any electronic system in place to manage environmental conditions or any
donor data, a validation study of the system should be assessed.
9 Directive 2006/17/EC of the European Parliament and of the Council (Annex IV)
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