Guide to the quality and safety of tissues and cells for human application 

Everything you need to know about handling cells and tissues

ESHRE Contributors and their position at the time:
- Maria José de Los Santos, Spain, SIG Embryology Past Coordinator
- Kersti Lundin, Sweden, Chair of ESHRE
- Cristina Magli, Italy, ESHRE Chair-elect
- Carlos Plancha, Portugal, former ExCo member
- Kelly Tilleman, Belgium, SIG Safety and Quality in ART Coordinator
- Anna Veiga, Spain, former ESHRE Chair
- Soeren Ziebe, former ExCo member

Human tissues and cells are being increasingly used in a variety of ways, and although advances in transplantation therapy have unquestionable benefits, their use raises questions about safety and quality.

The 4th version of the Guide to the quality and safety on tissues and cells for human application, published in September 2019, is now available. The Guide contains technical information and guidance for professionals working in a tissue establishment, inspectors auditing the establishments, and Health Authorities responsible for tissues and cells for human application. It collates the most up to date information to provide a comprehensive overview of the most recent advances in the field, with the aim to support professionals at a practical level and contribute to improve the rate of successful and safe clinical application of tissues and cells of human origin.

Two chapters are specific for Medically assisted reproduction (Chapter 27) and Fertility preservation (Chapter 28) and have been written with the collaboration of ESHRE. General requirements for all tissues and cells are also written in the general Chapters (Part A of the Guide).

The guide can be downloaded online for free at the EDQM Freepub website (, please click on the image. Paper copies can also be purchased at the EDQM Store (