Guide to the Quality and Safety of Tissues and Cells for Human Application

Download or read book Guide to the Quality and Safety of Tissues and Cells for Human Application written by European Directorate for the Quality of Medicines & Healthcare and published by . This book was released on 2013-10-11 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 two 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