What has changed in this 4th Edition?
This 4th Edition has been fully revised and updated with the most recent developments in the field of tissues and cells.
The Guide is now divided into 5 sections:
- Part A (Chapters 1-16) contains general requirements applicable to all tissue establishments and organisations involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells.
- Part B (Chapters 17-28) contains specific guidelines and requirements for the various tissue and cell types.
- Part C (Chapters 29-35) addresses novel therapeutic approaches. As the fields of donation and transplantation of tissues and cells evolve, new and more sophisticated technologies provide opportunities to make tissues and cells safer and their engraftment more effective. This section includes not only tissues and cells that are already in routine use in patients but also others that are in the research and development phase and are currently undergoing clinical trials.
- Part D includes the new “Tissue and Cell Monographs” providing information on those tissue and cell preparations and clinical applications which are precisely defined and have been shown to be safe and effective when used in patients (consolidated processing for a consolidated use). Tissue and cell monographs are complementary to other sections of the Guide and can be useful tools for tissue establishments and Health Authorities, providing the minimum criteria and controls necessary for ensuring the quality of tissues and cells processed by tissue establishments.
- Part E contains the newly developed Good Practice Guidelines (GPGs) for tissue establishments that follow EU Directives with the aim of promoting and ensuring high levels of quality in the field of human tissues and cells. These guidelines consolidate: the guidance already defined in the EU legislation; the recommendations from the main chapters of the Guide; the relevant elements derived from the detailed principles of GMP; the results of relevant EU-funded projects; and expert opinion consistent with current scientific knowledge. The GPGs, which should be seen as a complementary document for tissue establishments and inspectors/auditors, describe in detail, and from a practical point of view, the key elements to be defined and controlled for achieving comprehensive quality management in tissue establishments, as required by applicable EU legislation.