Principles of Steady-State Converter Analysis

Abstract

Quality requirements for cell therapy programmes are those that involve regulation and licensing operating at a European and National level e.g. the EU Directive on Tissues and Cells, National Tissue Regulations and voluntary accreditation schemes usually associated with International organisations e.g. FACT-JACIE and the World Marrow Donor Association (WMDA). Important apsects of patient and therapyrelated quality requirements are those for donors, including selection, evaluation and management. WMDA standards apply to unrelated donors whilst e.g. in the UK the requirements of FACT-JACIE and the Competent Authority - the Human Tissue Authority are essential. Donors must give appropriate consent and be properly evaluated to assess their fitness to donate and to exclude any condition that might harm the recipients of their cells. Testing must include markers of infectious disease (IDMs), HLA and ABO group. A significant proportion of unrelated donor Cell Therapy Products (CTPs) are collected from donors in other countries, including those outside the EU and organisations such as the Alliance for Harmonisation of Cell Therapy Accreditation (AHCTA) aim to achieve an international consensus on the requirements for donors and the donation process, working with the EU authorities and other bodies. Essential aspects of patient quality include definition of a minimum programme size, specifications for in- and out-patient facilities, access to appropriate supportive care e.g. Intensive Therapy Units, provision of CMV-appropriate blood products and access to doctors in radiation oncology, respiratory medicine and other key specialities. The Quality Management Programme (QMP) is central to every aspest of a Cell Therapy Programme today. Essential features include training programmes, audit, reporting and review of severe adverse events, accidents and complaints. The FACT-JACIE Standards also define the requirements for therapy administration, including radiotherapy, clinical research and data management. The burden of inspection for CT Programmes is increasing but with the aim of improving quality and safety.