Guide to the quality and safety of tissues and cells for human application
Human tissues and cells are being used in an increasing variety of ways, and advances in transplantation therapy have unquestionable benefits. Human cells and tissues for human application can save lives or restore essential functions, but the use of human tissues and cells also raises questions of safety and quality.
This 4th Edition of the Guide to the quality and safety of tissues and cells for human application contains information and guidance for:
- professionals involved in identifying potential donors,
- transplant co-ordinators managing the process of donation after death,
- bone marrow and cord blood collection centres,
- fertility clinics,
- tissue establishments processing and storing tissues and cells,
- testing laboratories,
- organisations responsible for human application,
- inspectors auditing the establishments,
- Health Authorities responsible for tissues and cells for human application.
The Guide is divided into five parts.
- Part A (Chapters 1-15) contains general requirements applicable to all tissue establishments and organisations.
- 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. It includes not only tissues and cells that are already in routine use in patients but others that are in research and development and are currently undergoing clinical trials.
- The new 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. 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.
- The new Part E contains the newly developed Good Practice Guidelines (GPGs) for tissue establishments that follow EU Directive. The GPGs are a complementary document for tissue establishments and inspectors/auditors, describing in detail and in a practical manner the key elements to be defined and controlled for achieving comprehensive quality management in tissue establishments, as required by applicable EU legislation.
The electronic version of this Guide can be downloaded for free online. The paper version is available for purchase at the EDQM Store.