{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T19:31:37Z","timestamp":1793302297669,"version":"4.5.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:00:00Z","timestamp":1791244800000},"content-version":"vor","delay-in-days":5,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Certification by the Joint Assurance Committee of the International Society for Cell &amp; Gene Therapy and the European Society for Blood and Marrow Transplantation (JACIE) is a key mechanism for strengthening quality, safety, and organizational performance in haematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor T (CAR\u2011T) therapy programmes. However, practical guidance on implementing a JACIE\u2011aligned quality management system (QMS) and preparing programmes for inspection remains limited. We present a structured methodology, developed and implemented within our programme, to support HSCT and CAR\u2011T therapy programmes in achieving inspection readiness while establishing a sustainable QMS that promotes continuous quality improvement.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We developed and implemented a stepwise approach based on the Plan\u2013Do\u2013Check\u2013Act cycle. It encompasses programme mapping and regulatory alignment, implementation of core QMS components across the collection, processing, and clinical areas, and QMS maintenance and inspection readiness, culminating in JACIE inspection with subsequent corrective actions. Key elements include process mapping, standard operating procedures, personnel competency, quality indicators, incident and deviation management, audits, validations and qualifications, product traceability, data submission, change control and risk assessment, feedback mechanisms, document management, and structured QMS review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The framework was successfully implemented within our HSCT and CAR\u2011T therapy programme, establishing a unified JACIE-aligned QMS across the collection, processing, and clinical areas. It strengthened governance, multidisciplinary coordination, and standardization of quality management activities, providing an approach applicable to both initial JACIE accreditation and subsequent reaccreditation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This structured methodology provides a practical and scalable framework for implementing and maintaining a JACIE-aligned QMS in HSCT and CAR-T therapy programmes, supporting inspection readiness, multidisciplinary coordination, and the safety of patients, donors, and haematopoietic cellular therapy products. JACIE certification and its associated QMS should be viewed not as the endpoint of quality management but as part of an ongoing process of organizational learning and continuous quality improvement.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/intqhc\/mzag162","type":"journal-article","created":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T11:27:33Z","timestamp":1791113253000},"source":"Crossref","is-referenced-by-count":0,"title":["Preparing HSCT and CAR\u2011T therapy programmes for JACIE inspection: a structured methodological approach to implementing a quality management system"],"prefix":"10.1093","volume":"38","author":[{"given":"Dimitrios","family":"Bourantas","sequence":"first","affiliation":[{"name":"Department of Haematology, Hospital Universitario Donostia , San Sebastian,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Panizo","sequence":"additional","affiliation":[{"name":"Department of Haematology, Hospital Universitario Donostia , San Sebastian,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,10,6]]},"reference":[{"key":"2026102914470887200_mzag162-B1","author":"Hematopoietic Cellular Therapy Accreditation Manual, Ninth Edition"},{"key":"2026102914470887200_mzag162-B2","doi-asserted-by":"publisher","first-page":"1651","DOI":"10.1038\/s41409-021-01227-8","article-title":"Hematopoietic cell transplantation and cellular therapy survey of the EBMT: monitoring of activities and trends over 30 years","volume":"56","author":"Passweg","year":"2021","journal-title":"Bone Marrow Transplant"},{"key":"2026102914470887200_mzag162-B3","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1038\/s41409-025-02524-2","article-title":"The 2023 EBMT report on hematopoietic cell transplantation and cellular therapies. 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