Gapp

GAPP Joint Action is aiming at facilitating the development of a common and optimal approach to assess and authorize preparation processes in blood and tissues establishments (BEs and TEs), adapting requirements as prescribed by Article 29 of Directive 2002/98/EC and Article 28 of Directive 2004/23/EC .

Since the directives for these fields were adopted, significant technical developments have taken place and the complexity of preparation processes has greatly increased. Increasing complexity of processing can bring significant quality and functionality improvements for patients, and/or more efficient use of donations, but it can also bring increased risk, particularly as the level of complexity brings the final product towards the borderline with medicinal products.