Fiche du document
21 avril 2022
- handle: 10670/1.gr94n2
- halshs: halshs-03780272
info:eu-repo/semantics/OpenAccess
Sujets proches
Products, Manufactured Manufactured goods Products Manufactured productsCiter ce document
Julie Veran et al., « Quality control and batch release aspects of Advanced Therapy Medicinal Products », HALSHS : archive ouverte en Sciences de l’Homme et de la Société, ID : 10670/1.gr94n2
Métriques
Partage / Export
Résumé
Quality control and batch release raise specific challenges for ensuring quality and complying with regulatory requirements in order to obtain manufacturing and marketing authorizations for Advanced Therapy Medicinal Products (ATMPs). ATMPs are medicinal products based on genes, cells and tissues that have been specifically regulated in the European Union (EU) from 2007. In the guidelines on Good Manufacturing Practices (GMP) specific to ATMPs from the European Commission, specific requirements cover quality control and batch release. They are distinct from the ones than can be found in other guidelines on GMP applicable to other kinds of biological medicinal products. Through a comparative textual analysis of the GMP guidelines for biological medicinal products and ATMPs, this poster will highlight the key areas of similarities and differences. Our analysis mainly focuses on qualification and validation procedures, batch release process, quality defects and product recalls, and automated production of ATMPs. This analysis reveals why we have two different texts and whether they are based on substantial differences regarding quality control and batch release between ATMPs and other types of biological medicinal products.