The Quality Management Ecosystem in Cell Therapy in Catalonia (Spain) : An Opportunity for Integrating Standards and Streamlining Quality Compliance
Vives Armengol, Joaquim (Universitat Autònoma de Barcelona. Departament de Medicina)
Sòria, Maria Glòria (Banc de Sang i Teixits)
McGrath, Eoin (International Council for Commonality in Blood Banking Automation)
Magri, Mara (ASST Papa Giovanni XXIII)

Fecha:	2022
Resumen:	Cell therapies are required to meet with compulsory regulations that co-exist with other optional standards and guidelines that together compose a complex quality management system. Indeed, reliable insights on the mechanisms of action and safety of novel cell-based therapies require adherence to solid quality management structures in all steps of the value chain, from early research and tissue procurement to clinical trials and biovigilance, thus guaranteeing reproducibility and solid foundations for better science and improved clinical practice. Herein we present the concept of the quality ecosystem as a tool to understand and assist all stakeholders involved in developing and structuring the integration of standards as novel developments are taking place. We conclude that the various quality management initiatives can all be thought about under the umbrella of an ecosystem.
Ayudas:	Instituto de Salud Carlos III PI19/01788
Nota:	Altres ajuts: e Spanish Advanced Therapy Network (TERAV, expedient No. RD21/0017/0022); Generalitat de Catalunya as Consolidated Research Group (ref. 2017SGR719)
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Cell therapy ; Quality standards ; Quality compliance ; JACIE ; GMP ; ISO9001 ; FACT ; NetCord ; AABB ; Integrated management system
Publicado en:	Cells, Vol. 11, Num. 13 (july 2022) , ISSN 2073-4409

DOI: 10.3390/cells11132112
PMID: 35805196

10 p, 260.0 KB

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