Process Steps from Cell-Line Preparation to Manufacture of Personalized Medicines

摘要

Compliance with Good Manufacturing Practice ("GMP") 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 patients under Article 3(7) of Directive 2001/83/EC1 (so called "hospital exemption") must be manufactured under equivalent quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorization.