According to Directive 2006/86/EC, validation (or ‘qualification’ in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, piece of equipment or environment will consistently produce a product meeting its pre-determined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use”
According to this Directive, the validation is compulsory considering that:
a) All critical equipment and technical devices must be identified and validated(2006/86/ECAnnex 1);
b) The critical processing procedures must be validated and must not render the tissues and cells clinically ineffective or harmful to the recipient’ (2006/86/EC Annex 2).
Tissue allograft may have profoundly positive or negative effects on patients. Our products and processes must achieve defined criteria to ensure that they perform as intended. Thus, validation is how we prove (to ourselves and to regulators) that this is the case.
Thus, it is a requirement of the Good Tissue Practices that the TE identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the tissues and cells, should be validated. A risk assessment approach should be used to determine the scope and extent of validation
This risk assessment should take into account all the equipment (e.g. autoclave, incubator, freeze drier) facilities (e.g. clean rooms, laminar flow module), electronic systems (e.g. clean rooms environmental monitoring system, tissues processing system) and processes (e.g. musculoskeletal processing, skin processing, clean rooms disinfection, tissue transport, analytical methods) which may impact in the quality of processed tissues.
The results from the risk assessment study regarding the scope of validation activities within a Tissue Establishment should be covered in a Validation Master Plan.
The contents of the validation plan shall be at least:
a) Description of the tissue establishment;
b) List of equipment, facilities, electronic systems and processes that need to be qualified or validated;
c) State of validation of each element within the scope;
d) Validation programme;
e) Validation activities responsibilities;
f) Procedures related to validation activities;
g) Criteria for requalification or revalidation.