Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process

The adherence to accreditation programs proves the institutions' voluntary effort to pursue the quality and safety of their products and services by meeting internationally accepted standards audited by experts in the field, external to the service. Meeting such standards often exceeds domestic...

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Autores principales:	Gil Cunha De Santis, Eugênia Maria Amorim Ubiali, Ana Paula Rocha Diniz Zanelli, Alfredo Mendrone Junior, Andreza Feitoza, José Mauro Kutner, Maristela Delgado Orellana, Sílvia Renata Cornelio Parolin Rizzo, Dimas Tadeu Covas, Dante Mário Langhi Junior
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	CAR T-cell therapy Cell therapy Accreditation Reference standards Quality management Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/3b4a8aecef8d41c9b15dd4dcacba9c3e
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spelling	oai:doaj.org-article:3b4a8aecef8d41c9b15dd4dcacba9c3e2021-11-18T04:51:02ZAssociação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process2531-137910.1016/j.htct.2021.09.006https://doaj.org/article/3b4a8aecef8d41c9b15dd4dcacba9c3e2021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2531137921001401https://doaj.org/toc/2531-1379The adherence to accreditation programs proves the institutions' voluntary effort to pursue the quality and safety of their products and services by meeting internationally accepted standards audited by experts in the field, external to the service. Meeting such standards often exceeds domestic legal requirements. However, service providers are not released from complying with the legal requirements, both local and international, pertinent to the field. Accreditation programs use the precepts of the quality management system to validate and standardize processes, monitor results through quality control, proficiency testing, and indicators, and perform risk management. For cellular therapy services, the assessing agencies available in our field are the AABB/ABHH (American Association of Blood Banks/Brazilian Association of Hematology, Hemotherapy and Cellular Therapy) and FACT-JACIE (Foundation for the Accreditation of Cellular Therapy-Joint Accreditation Committee, ISCT/EBMT). Both agencies require that the accredited organization meets all the standards defined in each program. Applying services also have to establish and comply with a quality management standard that demonstrates procedural interrelationship to ensure product and service quality. This paper aims to concisely outline the essential features of those two accreditation programs, along with a brief overview of the accreditation process under each of them.Gil Cunha De SantisEugênia Maria Amorim UbialiAna Paula Rocha Diniz ZanelliAlfredo Mendrone JuniorAndreza FeitozaJosé Mauro KutnerMaristela Delgado OrellanaSílvia Renata Cornelio Parolin RizzoDimas Tadeu CovasDante Mário Langhi JuniorElsevierarticleCAR T-cell therapyCell therapyAccreditationReference standardsQuality managementDiseases of the blood and blood-forming organsRC633-647.5ENHematology, Transfusion and Cell Therapy, Vol 43, Iss , Pp S42-S45 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	CAR T-cell therapy Cell therapy Accreditation Reference standards Quality management Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	CAR T-cell therapy Cell therapy Accreditation Reference standards Quality management Diseases of the blood and blood-forming organs RC633-647.5 Gil Cunha De Santis Eugênia Maria Amorim Ubiali Ana Paula Rocha Diniz Zanelli Alfredo Mendrone Junior Andreza Feitoza José Mauro Kutner Maristela Delgado Orellana Sílvia Renata Cornelio Parolin Rizzo Dimas Tadeu Covas Dante Mário Langhi Junior Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process
description	The adherence to accreditation programs proves the institutions' voluntary effort to pursue the quality and safety of their products and services by meeting internationally accepted standards audited by experts in the field, external to the service. Meeting such standards often exceeds domestic legal requirements. However, service providers are not released from complying with the legal requirements, both local and international, pertinent to the field. Accreditation programs use the precepts of the quality management system to validate and standardize processes, monitor results through quality control, proficiency testing, and indicators, and perform risk management. For cellular therapy services, the assessing agencies available in our field are the AABB/ABHH (American Association of Blood Banks/Brazilian Association of Hematology, Hemotherapy and Cellular Therapy) and FACT-JACIE (Foundation for the Accreditation of Cellular Therapy-Joint Accreditation Committee, ISCT/EBMT). Both agencies require that the accredited organization meets all the standards defined in each program. Applying services also have to establish and comply with a quality management standard that demonstrates procedural interrelationship to ensure product and service quality. This paper aims to concisely outline the essential features of those two accreditation programs, along with a brief overview of the accreditation process under each of them.
format	article
author	Gil Cunha De Santis Eugênia Maria Amorim Ubiali Ana Paula Rocha Diniz Zanelli Alfredo Mendrone Junior Andreza Feitoza José Mauro Kutner Maristela Delgado Orellana Sílvia Renata Cornelio Parolin Rizzo Dimas Tadeu Covas Dante Mário Langhi Junior
author_facet	Gil Cunha De Santis Eugênia Maria Amorim Ubiali Ana Paula Rocha Diniz Zanelli Alfredo Mendrone Junior Andreza Feitoza José Mauro Kutner Maristela Delgado Orellana Sílvia Renata Cornelio Parolin Rizzo Dimas Tadeu Covas Dante Mário Langhi Junior
author_sort	Gil Cunha De Santis
title	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process
title_short	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process
title_full	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process
title_fullStr	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process
title_full_unstemmed	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process
title_sort	associação brasileira de hematologia, hemoterapia e terapia celular consensus on genetically modified cells. vi: accreditation process
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/3b4a8aecef8d41c9b15dd4dcacba9c3e
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Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. VI: Accreditation process

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