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) and Therapeutic Cells (TC) 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. The 5th edtion of the Standards are published on the web site on 1 March 2012 and can be downloaded from from the Document Centre. Contents INTRODUCTION PART A TERMINOLOGY, ABBREVIATIONS, AND DEFINITIONS A1 Terminology A2 Abbreviations A3 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 Therapy Administration 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 Processing 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 Process Controls D7 Coding and Labeling of Cellular Therapy Products D8 Distribution D9 Storage D10 Transportation, Shipping, and Receipt D11 Disposal D12 Records APPENDIX I Cellular Therapy Product Labeling APPENDIX II Cellular Therapy Product Labels for Shipping and Transport on Public Roads APPENDIX III Accompanying Documents at Distribution |
Standards |