EMA publishes manufacturing guidance for ATMPs
The European Commission released guidelines on good manufacturing practices (GMP) for advanced therapy medicinal products (ATMPs), which include therapies made from genes, tissue or cells. The guidelines adapt EU GMP requirements to the specific characteristics of ATMPs in order to address the complexity and variability of the therapies.
The guidance specifies a risk-based approach for ATMP manufacturing and testing that places the responsibility on the manufacturer to ensure the quality of product it produces. Since quality risks associated with an ATMP are "highly dependent on the biological characteristics and origin" of the specific product, EMA's guidance charges the manufacturer to design and employ measures necessary to control or mitigate the specific risks of the product and manufacturing process. The guidelines also provide direction on personnel, premises and equipment, documentation, and aspects of manufacturing specific to ATMPs such as seed lots and cell banks. ...