HEMATOPOIETIC ELLULAR THERAPY - ebmt.org

1 HEMATOPOIETIC Accreditation ManualELLULAR HERAPYTCSEVENTH edition INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION ACCREDITATION MANUAL Guidance to Accompany the FACT-JACIE International Standards for HEMATOPOIETIC Cellular THERAPY Product Collection, Processing, and Administration, seventh edition 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.

2 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. 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.

3 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. COPYRIGHT 2018 COPYRIGHT 2018 FOUNDATION FOR THE ACCREDITATION JOINT ACCREDITATION COMMITTEE - OF CELLULAR THERAPY (FACT) ISCT and EBMT (JACIE)

4 _____ FACT-JACIE International Standards Accreditation Manual seventh edition This page intentionally left FACT-JACIE International Standards Accreditation Manual seventh edition i TABLE OF CONTENTS Page Number INTRODUCTION 1 PART A TERMINOLOGY, TENETS, ABBREVIATIONS, AND DEFINITIONS 3 A1 Terminology 4 A2 Tenets 4 A3 Abbreviations 4 A4 Definitions 5 PART B CLINICAL PROGRAM STANDARDS 19 B1 General 20 B2 Clinical Unit 28 B3 Personnel 38 B4 Quality Management 70 B5 Policies and Standard Operating Procedures 107 B6 Allogeneic and Autologous Donor Selection, Evaluation.

5 And Management 114 B7 Recipient Care 141 B8 Clinical Research 155 B9 Data Management 158 B10 Records 161 PART CM MARROW COLLECTION FACILITY STANDARDS 171 CM1 General 172 CM2 Marrow Collection Facility 175 CM3 Personnel 183 CM4 Quality Management 190 CM5 Policies and Standard Operating Procedures 190 _____ FACT-JACIE International Standards Accreditation Manual seventh edition ii CM6 Allogeneic and Autologous Donor Evaluation and Management 197 CM7 Coding and Labeling of Cellular THERAPY Products 210 CM8 Process Controls 225 CM9 Cellular THERAPY Product Storage 235 CM10 Cellular THERAPY Product Transportation and Shipping 236 CM11 Records 239 CM12 Direct Distribution to Clinical Program 239 PART C APHERESIS COLLECTION FACILITY STANDARDS 241 C1 General 242 C2 Apheresis Collection Facility 246 C3 Personnel 253 C4 Quality Management 264 C5 Policies and Standard Operating Procedures 295 C6 Allogeneic and Autologous Donor Evaluation and Management 303 C7 Coding and Labeling of Cellular THERAPY Products 319 C8 Process Controls 335 C9 Cellular THERAPY Product

6 Storage 349 C10 Cellular THERAPY Product Transportation and Shipping 350 C11 Records 353 C12 Direct Distribution to Clinical Program 363 PART D PROCESSING FACILITY STANDARDS 365 D1 General 366 D2 Processing Facility 369 D3 Personnel 378 D4 Quality Management 389 D5 Policies and Standard Operating Procedures 422 D6 Equipment, Supplies, and Reagents 429 D7 Coding and Labeling of Cellular THERAPY Products 438 _____ FACT-JACIE International Standards Accreditation Manual seventh edition iii D8 Process Controls 453 D9 Cellular THERAPY Product Storage 472 D10 Cellular THERAPY Product Transportation and Shipping 480 D11 Distribution and Receipt 485 D12 Disposal 493 D13 Records 496 APPENDIX I Minimum Number of New Patients for Accreditation 509 APPENDIX II Cellular THERAPY Product Labeling 513 APPENDIX III Cellular THERAPY Product Labels for Shipping and Transport on Public Roads 515 APPENDIX IV

7 Accompanying Documentation 517 ACKNOWLEDGEMENTS 519 CONTACT INFORMATION 521 INDEX 523 _____ FACT-JACIE International Standards Accreditation Manual seventh edition iv This page intentionally left blank. _____ FACT-JACIE International Standards Accreditation Manual seventh edition 1 INTRODUCTION This Accreditation Manual is intended to accompany the FACT-JACIE International Standards for HEMATOPOIETIC Cellular THERAPY Product Collection, Processing, and Administration, seventh edition , 2018 (the Standards). The purpose is to explain the intent and rationale of specific standards, to provide examples of alternative approaches that would be considered compliant with standards, and detail the type of documentation that may be used to verify compliance during the accreditation process.

8 This information is intended to be helpful to applicants for accreditation and to on-site inspectors. There are potentially many effective ways to meet the Standards. The examples listed here do not represent the only alternatives. 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. 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).

9 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. 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.

10 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. 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.