Today’s standardization… is the necessary foundation on which tomorrow’s improvement will be based. If you think of ‘standardization’ as the best you know today, but which is to be improved tomorrow… you get somewhere. But if you think of standards as confining, then progress stops. Henry Ford Today and Tomorrow (originally printed 1926) (Productivity Press, 1988) The Standards are the cornerstone of the JACIE accreditation program. Believing that quality care can only be achieved if both clinical and laboratory issues are effectively addressed, the FACT-JACIE Standards are the only set of requirements that include both clinical and laboratory practices. The Standards currently apply to Hematopoietic Progenitor Cells (HPC) obtained from bone marrow, peripheral blood, and umbilical cord blood. FACT-JACIE Standards are evidence-based requirements set by international teams of world-renowned experts vested in the improvement and progress of cellular therapy. Standards are developed by consensus within committees consisting of knowledgeable clinicians, scientists, technologists, and quality experts that span the entire continuum of cell manufacturing. International leaders in cellular therapy programs, cord blood banks, and registries serve on the Standards Development Committees. Liaison representation from consumers and regulatory bodies are consulted throughout the development process. This results in detailed, comprehensive Standards that address every aspect of cell manufacturing and administration that impacts the quality of products and therapeutic care. The Standards are based upon published medical evidence whenever possible. When published data is not available, requirements are based upon accepted scientific theory. The development process includes a period for public review and comment, legal review, and approval by the respective FACT and JACIE Boards. Previous editions
The 6th edition of the Standards were published on 1 March 2015. The documents can be downloaded from from the 'Standards' section in the Document Centre. Edition 6.01 was published on 2 February 2017 to incorporate standards for administration of immune effector cells. These Hematopoietic Cell Therapy Standards apply to hematopoietic progenitor cells, defined as self-renewing and/or multi-potent stem cells capable of maturation into any of the hematopoietic lineages, lineage-restricted pluri-potent progenitor cells, and committed progenitor cells from hematopoietic sources (bone marrow, umbilical cord blood, peripheral blood, or other tissue source). These Standards also include mononuclear cells, defined as nucleated cells from any hematopoietic tissue source (marrow, peripheral blood, umbilical cord, and placental blood) collected for therapeutic use other than as hematopoietic progenitor cells. Contents PART A TERMINOLOGY, TENETS, ABBREVIATIONS, AND DEFINITIONS A1 Terminology A2 Tenets A3 Abbreviations A4 Definitions PART B CLINICAL PROGRAM STANDARDS B1 General B2 Clinical Unit B3 Personnel B4 Quality Management B5 Policies and Procedures B6 Allogeneic and Autologous Donor Selection, Evaluation, and Management B7 Recipient Care B8 Clinical Research B9 Data Management B10 Records PART CM MARROW COLLECTION FACILITY STANDARDS CM1 General CM2 Marrow Collection Facility CM3 Personnel CM4 Quality Management CM5 Policies and Procedures CM6 Allogeneic and Autologous Donor Evaluation and Management CM7 Coding and Labeling of Cellular Therapy Products CM8 Process Controls CM9 Cellular Therapy Product Storage CM10 Cellular Therapy Product Transportation and Shipping CM11 Records CM12 Direct Distribution to Clinical Program PART C APHERESIS COLLECTION FACILITY STANDARDS C1 General C2 Apheresis Collection Facility C3 Personnel C4 Quality Management C5 Policies and Procedures C6 Allogeneic and Autologous Donor Evaluation and Management C7 Coding and Labeling of Cellular Therapy Products C8 Process Controls C9 Cellular Therapy Product Storage C10 Cellular Therapy Product Transportation and Shipping C11 Records C12 Direct Distribution to Clinical Program PART D PROCESSING FACILITY STANDARDS D1 General D2 Processing Facility D3 Personnel D4 Quality Management D5 Policies and Procedures D6 Equipment, Supplies, and Reagents D7 Coding and Labeling of Cellular Therapy Products D8 Process Controls D9 Cellular Therapy Product Storage D10 Cellular Therapy Product Transportation and Shipping D11 Distribution and Receipt D12 Disposal D13 Records APPENDIX I Minimum Number of New Patients for Accreditation APPENDIX II Cellular Therapy Product Labeling APPENDIX III Cellular Therapy Product Labels for Shipping and Transport on Public Roads APPENDIX IV Accompanying Documents at Distribution APPENDIX V Changes to Sixth Edition Standards |
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