FACT-JACIE International Standards for HEMATOPOIETIC ...

1 SEVENTH EDITION CELLULAR THERAPYP roduct Collection, Processing, and AdministrationforFACT-JACIE International Standards International Standards FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION Seventh Edition Version March 2018 NOTICE These Standards are designed to provide minimum guidelines for programs, facilities, and individuals performing cellular therapy or providing support services for such procedures. These Standards are not intended to establish best practices or include all procedures and practices that a program, facility, or individual should implement if the standard of practice in the community or applicable governmental laws or regulations establish additional requirements.

2 Each program, facility, and individual should analyze its practices and procedures to determine whether additional Standards apply. Compliance with these Standards is not an exclusive means of complying with the standard of care in the industry or community or with local, national, or International laws or regulations. The Foundation for the Accreditation of Cellular Therapy and the Joint Accreditation Committee ISCT and EBMT expressly disclaim any responsibility for setting maximum Standards and further expressly disclaim any responsibility, liability, or duty to member programs, directors, staff, or program donors or patients for any such liability arising out of injury or loss to any person by the failure of member programs, directors, or staff to adhere to the Standards or related guidance.

3 COPYRIGHT 2018 COPYRIGHT 2018 FOUNDATION FOR THE ACCREDITATION JOINT ACCREDITATION COMMITTEE - OF CELLULAR THERAPY (FACT) ISCT and EBMT (JACIE)_____ FACT-JACIE International Standards Seventh Edition This page intentionally left FACT-JACIE International Standards Seventh Edition i TABLE OF CONTENTS Page Number INTRODUCTION 1 PART A TERMINOLOGY, TENETS, ABBREVIATIONS, AND DEFINITIONS 5 A1 Terminology 6 A2 Tenets 6 A3 Abbreviations 6 A4 Definitions 7 PART B CLINICAL PROGRAM Standards 19 B1 General 20 B2 Clinical Unit 21 B3 Personnel 23 B4 Quality Management 32 B5 Policies and Standard Operating Procedures 40 B6 Allogeneic and Autologous Donor Selection, Evaluation.

4 And Management 42 B7 Recipient Care 47 B8 Clinical Research 52 B9 Data Management 53 B10 Records 54 PART CM MARROW COLLECTION FACILITY Standards 57 CM1 General 58 CM2 Marrow Collection Facility 58 CM3 Personnel 60 CM4 Quality Management 62 CM5 Policies and Standard Operating Procedures 62 CM6 Allogeneic and Autologous Donor Evaluation and Management 64 CM7 Coding and Labeling of Cellular Therapy Products 67 _____ FACT-JACIE International Standards Seventh Edition ii CM8 Process Controls 69 CM9 Cellular Therapy Product Storage 72 CM10 Cellular Therapy Product Transportation and Shipping 72 CM11 Records 73 CM12 Direct Distribution to Clinical Program 73 PART C APHERESIS COLLECTION FACILITY Standards 75 C1 General 76 C2 Apheresis Collection Facility 76 C3 Personnel 78 C4 Quality Management 80 C5 Policies and Standard Operating Procedures 87 C6 Allogeneic and Autologous Donor Evaluation and Management 89 C7 Coding and Labeling of Cellular Therapy Products 93 C8 Process Controls 95 C9 Cellular Therapy Product Storage 98 C10 Cellular Therapy Product Transportation and Shipping 99 C11 Records 99 C12 Direct Distribution to Clinical

5 Program 102 PART D PROCESSING FACILITY Standards 103 D1 General 104 D2 Processing Facility 104 D3 Personnel 106 D4 Quality Management 107 D5 Policies and Standard Operating Procedures 114 D6 Equipment, Supplies, and Reagents 117 D7 Coding and Labeling of Cellular Therapy Products 119 D8 Process Controls 122 D9 Cellular Therapy Product Storage 126 D10 Cellular Therapy Product Transportation and Shipping 129 D11 Distribution and Receipt 130 _____ FACT-JACIE International Standards Seventh Edition iii D12 Disposal 133 D13 Records 134 APPENDIX I Minimum Number of New Patients for Accreditation 139 APPENDIX II Cellular Therapy Product Labeling 141 APPENDIX III Cellular Therapy Product Labels for Shipping and Transport on Public Roads 143 APPENDIX IV Accompanying Documentation 145 ACKNOWLEDGEMENTS 147

6 CONTACT INFORMATION 149 INDEX 151 _____ FACT-JACIE International Standards Seventh Edition iv This page intentionally left FACT-JACIE International Standards Seventh Edition 1 INTRODUCTION The FACT-JACIE International Standards for HEMATOPOIETIC Cellular Therapy Product Collection, Processing, and Administration, seventh edition, represents the fifth collaboration to publish comprehensive quality-based Standards in cellular therapy between the Foundation for the Accreditation of Cellular Therapy (FACT) and JACIE, the Joint Accreditation Committee of ISCT and EBMT, the European Society for Blood and Marrow Transplantation.

7 FACT was founded in 1996 by the American Society for Blood and Marrow Transplantation (ASBMT) and the International Society for Cellular Therapy (ISCT), published the first edition of Standards that year, and initiated the North American inspection and accreditation program based on these Standards in 1997. JACIE was established in 1999, adopted the first edition of FACT Standards in its entirety, and jointly reviewed the second edition in 2002. Subsequent editions of Standards have been jointly developed, published, and approved by FACT and JACIE. The major objective of the FACT-JACIE International Standards for HEMATOPOIETIC Cellular Therapy Product Collection, Processing, and Administration (the Standards ) is to promote quality medical and laboratory practice in HEMATOPOIETIC progenitor cell transplantation and related therapies using HEMATOPOIETIC -derived cellular products.

8 These FACT-JACIE 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). Nucleated cells or mononuclear cells from any HEMATOPOIETIC tissue source (marrow, peripheral blood, umbilical cord, and placental blood) collected for therapeutic use other than as HEMATOPOIETIC progenitor cells. These cells are used for any clinical indication, may be further enumerated or identified by CD designation or other methodology, or may be used in further manufacturing of products for administration.

9 O For HEMATOPOIETIC progenitor cells or mononuclear cells derived from umbilical cord or placental blood, these Standards apply only to the administration of the cellular therapy product, applying the relevant clinical and processing Standards for product preparation and transplantation. Standards for cord blood collection and banking are available in a separate document, NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, available at Immune effector cells derived from these sources, defined broadly as any cells, in vitro modified or not, that are capable of eliciting or modulating an immune response.

10 This broad designation includes cellular therapy products with widely diverse manufacturing methods, constructs, clinical indications, and safety and toxicity profiles. Individual programs and responsible personnel must understand the immune effector cell products in clinical use, the spectrum and timing of potential and anticipated toxicities associated with each product or type of product, implement relevant evaluation and mitigation strategies, and apply these Standards appropriately to each situation. The FACT-JACIE Standards do not address the collection, processing, or administration of erythrocytes, platelets, mature granulocytes, plasma, or plasma-derived products intended for transfusion support.