Abstract
Abstract
Background
Certification by the Joint Assurance Committee of the International Society for Cell & Gene Therapy and the European Society for Blood and Marrow Transplantation (JACIE) is a key mechanism for strengthening quality, safety, and organisational performance in haematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor T (CAR‑T) therapy Programmes. However, practical guidance on implementing a JACIE‑aligned 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‑T therapy Programmes in achieving inspection readiness while establishing a sustainable QMS that promotes continuous quality improvement.
Methods
We developed and implemented a stepwise approach based on the Plan–Do–Check–Act 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.
Results
The framework was successfully implemented within our HSCT and CAR‑T therapy Programme, establishing a unified JACIE-aligned QMS across the Collection, Processing, and Clinical areas. It strengthened governance, multidisciplinary coordination, and standardisation of quality management activities, providing an approach applicable to both initial JACIE accreditation and subsequent reaccreditation.
Conclusion
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 hematopoietic 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 organisational learning and continuous quality improvement.