NeuroStemCell
European Consortium for Stem Cell Therapy in Neurodegenerative Desease
Gmp Committee
The GMP committee oversees and guide the implementation of GMP standards into the program.
Members:
Bengt Juliusson (NsGene), Ida Biunno (Biorep) and Stephen Dunnett (Cardiff University).
Good Manufacturing Practice (GMP) is defined as “That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.” The principles and guidelines for GMP are stated in two Directives; Directive 2003/94/EC for medicinal products and investigational medicinal products for human use and Directive 91/412/EEC concerning veterinary medicinal products. Compliance with these principles and guidelines is mandatory within the European Economic Area. Detailed guidelines in the form of the Guide to Good Manufacturing Practice provide interpretation of the principles and guidelines and these in turn are supplemented by a series of annexes which modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic. They are developed by the GMP inspection services group and are published as Volume 4 of EudraLex by the European Commission.