1. Introduction – scope, general principles
“Compliance with good manufacturing practice is mandatory for all medicinal products that have been granted a marketing authorization. Likewise, the manufacture of investigational medicinal products must be in accordance with GMP. Advanced therapy medicinal products that are administered to the patient under Article 3(7) of Directive 2001/83/EC so called hospital exemption must be manufactured under equivalent quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorization”.