The European Good Tissue Practice (GTP) guidelines and the adjacent training model have been established as an outcome of the EU-funded project - Euro-GTPs - to provide a complete and detailed tissue banking information package for tissue bankers as well as for tissue establishment (TE) inspectors in Europe. These guidelines bring together the current minimum regulatory requirements of the European tissue and cells Directives and go one step further - incorporating useful good manufacturing practice (GMP) principles and utilizing the expertise of tissue bank experts to provide a set of practical recommendations for good practice in European TEs. The GTPs are developed to be a helpful tool for all kinds of TEs in different phases of their development and evolution as well as for competent authorities (CA) when performing TE inspections.
The aim of the Euro-GTP project is to promote the application of these practices throughout Europe so as to increase the know-how and the level of performance of tissue banking staff, and to harmonize the techniques used. By harmonization of the practices to what is broadly considered as optimal, European TEs are expected to be able to routinely provide higher quality and safer tissues for transplantation and hence reduce the risk of disease transmission to recipients throughout Europe and increase the clinical effectiveness of transplanted grafts. This will contribute to a higher confidence in the exchange of tissues for transplant throughout Europe.
The GTP guidelines encompass procedural recommendations for (i) donor screening and selection for each tissue type, (ii) tissue procurement, processing, preservation and storage, as well as (iii) recommendations on how to validate these processes. The effectiveness of the recommended procedures has been assessed by putting them into practice in a TE with the required environmental conditions.
These guidelines have been structured in two main parts: generic good tissue practices (GTPs) and tissue-specific GTPs. The generic section comprises practical instructions on (i) generic processes carried out in TEs, (ii) risk assessment and (iii) validation methods for donor screening and tissue procurement, processing, preservation and storage, as well as basic requirements concerning infrastructure, personnel, documentation management, etc.. The tissue-specific sections comprise practical instructions on donor screening and tissue procurement, processing, preservation, storage and transportation related to ocular, amniotic membrane, skin, cardiovascular, and musculoskeletal tissues.
The web-based HOT-SPOT forum is an important supplement to the guidelines. It highlights areas where it is generally acknowledged that greater harmonization is needed, where consensus is lacking on the best practice to be applied, or where it is commonly thought that tools are needed to support improvements in practice. Practical examples and some particular tools for developing areas and where conversations can proceed on specific tissue banking topics are proposed. These HOT-SPOT issues are under regular revision and tissue bankers are urged to participate in the HOT-SPOT discussion on the web page. As consensus is reached and good practice on these topics is more clearly defined, these texts will move into the full guidance document. New hotspot topics will be added as necessary.
The GTPs have drawn upon the work of previously EU-funded projects, particularly the Sanco-EQSTB project and the EUSTITE project. The Sanco-EQSTB project, co-ordinated by Hospital Clinic between 2004 and 2007, published a Guide of Recommendations for Tissue Banking defining the fundamental quality and safety key points, a training system for tissue establishment (TE) personnel, a prototype of a tissue registry and a model for auditing TEs (Guide for Auditing) . The EUSTITE project developed guidance and training for Competent Authority inspectors along with tools and guidance for vigilance and surveillance.
This document has been prepared by drawing upon the European Union Directives on tissue banking and the Good manufacturing practice (GMP) Guidelines, together with text elaborated by the partners of the project from their own experience and knowledge and, in some cases, by building on professional society or nationally agreed standards.