Guide to the quality and safety of tissues and cells for human application 3rd ed. 2017

Format:
Corporate Author:
European Directorate for the Quality of Medicines and Healthcare
Publisher:
Council of Europe

This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that will help improve the rate of successful clinical application of tissues and cells. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. It has been divided into three parts. Part A contains general requirements applicable to all establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. Part B contains specific guidelines and requirements for the different tissue and/or cell types. The new Part C introduces novel therapeutic approaches, most of them under development, such as cell-based therapies, decellularisation techniques and the use of natural scaffolds for clinical application, or the human application of other human-derived substances such as breast milk, faecal microbiota, platelet-rich plasma or serum eye drops. This section 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. Implementation Date: 31.07.2017

Extent 459p. ISBN 9789287184436
Size N/A Price £55.00
Format Paperback Published 31 Jul 2017
Availability Out of stock - available to order Delivery Delivery options and charges