FACT Publishes Third Edition of the Common Standards for Cellular Therapies with a New Accompanying Accreditation Manual
The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application throughout product development and clinical trials.
This third edition of Common Standards remains consistent with previous editions, requiring a comprehensive quality management plan and established clinical, collection, and processing procedures. Additionally, this edition reflects the maturation of cellular therapy and the inclusion of more and diverse products such as genetically modified products. Quality management requirements include specific training in good manufacturing practice appropriate to the products being collected or processed; development and review of robust written agreements with entities providing services or products; comprehensive document control; and expanded auditing, outcome analysis, and data management and reporting requirements.
“The revisions were focused on harmonization with other parallel FACT standards and on advances (real and anticipated) of novel cellular therapies that would be covered under the Common Standards,” according to Dr. Paul Eldridge, Chair of the Common Standards Committee.
In this edition, emphasis is also placed on the criticality of labeling and chain of identity / chain of custody as product manufacturing frequently involves several cooperating entities to achieve collection of the cellular starting material, manufacture of the final product, transport of the cells and products among facilities, and clinical therapy administration. Because of its value in accurate and unambiguous identification, encoding information, and labeling of medical products of human origin, full implementation of ISBT 128 coding and labeling is required where possible.
FACT is excited to announce the publication of the first Accreditation Manual to accompany the third edition Standards. Significant thanks is given to Dr. Carolyn Keever-Taylor for her work in drafting the initial document for the committee to review. The Accreditation Manual “provides a valuable tool for users to self-assess their compliance with the Standards and ensure that they are inspection ready,” Dr. Paul Eldridge.
The Common Standards Committee consists of 13 expert members. Members reviewed clinical, collection, processing, and quality requirements. Following months of reviews and revisions, comments were submitted during an open public comment period. The committee considered all feedback, which totaled almost 100 comments, submitted by professionals from industry, clinical, non-profit, and regulatory settings. Final revisions were drafted by the committee and approved by the FACT Board of Directors. The FACT leadership expresses its gratitude to the committee members for their dedication and work to revise this third edition.
The third edition Common Standards became effective on March 30, 2023. All organizations accredited under these Standards are now expected to be in compliance with the requirements. Compliance Applications and inspections under the Common Standards will now only be accepted for the third edition.
Third Edition Common Standards [free download]
Third Edition Common Standards Accreditation Manual [free download]
Purchase printed copies of Standards
Purchase printed copies of the Accreditation Manual
FACT Resources to Assist Your Program Throughout the Accreditation Process
FACT aims to provide organizations with valuable resources to aid in achieving and maintaining their accreditation. Our website has useful documents for organizations in all phases of the accreditation process. However, we understand that finding the right information can become overwhelming at times especially for organizations completing their initial application or for personnel new to the accreditation process.
The following overview provides categories, definitions, and the location of important resources. We encourage you to share this information with all personnel involved in your organization’s FACT accreditation process:
The FACT Standards webpage contains links to the most recent versions of the four sets of Standards published by FACT:
- HCT Standards – FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
- Common Standards – Common Standards for Cellular Therapies
- Immune Effector Standards – Standards for Immune Effector Cells
- Cord Blood Bank Standards – NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration
The pages for each set of Standards contain useful documents relevant to the current editions of FACT Standards, including, but not limited to:
- FACT Standards and Accreditation Manuals
- Summary of Changes, Compare, and Crosswalk documents to identify changes between the previous and current versions of FACT Standards, if applicable.
- Forms used during the compliance application submission, including but not limited to Document Submission Requirements, Educational Activities, Critical Electronic Record Systems, and Facility Site Grids.
The above resources can also be found in the Cellular Therapy Library and Cord Blood Bank Library.
Accreditation Process Requirements
The Cellular Therapy Accreditation Process Requirements and Cord Blood Bank Accreditation Process Requirements provide a structured overview of the accreditation process, from completing the Compliance Application to requirements after the on-site inspection.
The Self-Assessment Tools can be used to assess readiness for FACT accreditation. They are located in the Cellular Therapy (CT) and Cord Blood Bank (CB) Libraries, and you will find individual self-assessment tools for each current set of FACT Standards:
- Hematopoietic Cellular Therapy Self-Assessment Tool, Seventh Edition
- Common Standards Self-Assessment Tool, Second Edition
- Immune Effector Cells Self-Assessment Tool, First Edition, Version 1.1
- CB Self-Assessment Tool, Seventh Edition
FACT’s comprehensive, robust training and development program is responsive to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. With a focus on real-life examples and practical application, FACT educational sessions provide tools not only for achieving accreditation, but for ensuring quality patient care in accordance with the Standards. The Education and Resources page contains links to upcoming and previously recorded events:
FACT Accreditation Coordinator
FACT’s Accreditation Coordinators provide these and additional FACT resource links in an email sent to organizations at the beginning of the compliance application process. Your accreditation coordinator is available throughout the accreditation process to answer questions via email or phone. The coordinator’s contact information is available in the accreditation portal.
Clinical Outcomes Resource Center
FACT supports blood and marrow transplant (BMT) programs’ efforts to evaluate one-year survival data to improve patient outcomes, advance the field, and maintain payer and public confidence. The Clinical Outcomes Resource Center includes comparative data sources, educational resources, guidelines for corrective action plans (CAP), as well as CAP examples.
Data Management Resource Center
The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans with the goal of providing education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. The Data Management Resource Center provides CIBMTR and educational resources, guidelines for data management submissions and examples, and audit report examples and templates.
Immune Effector Cells (IEC) Resource Center
FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for blood and marrow transplantation and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. The Immune Effector Cells (IEC) Resource Center includes resources to assist with understanding immune effector cells and implementing applicable FACT Standards.
Portal Resource Center
The Portal Resource Center provides access to all available resources and training materials for navigating and assisting organizations in completing applications in the portal.
Use the links below to access recent news releases, as well as current and previous volumes of our newsletter:
We hope that you find this information useful as you prepare for your next accreditation cycle. If you have additional suggestions regarding how FACT can better inform organizations of the resources available, please email firstname.lastname@example.org.
Additional FACT Volunteer Opportunities
By: Andra Moehring, MHA, FACT Standards Development Manager
The Foundation for the Accreditation of Cellular Therapy (FACT) has several committees to help FACT achieve its vision of being the premier organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.
In addition to other standing committees, FACT has a special committee for which we are seeking volunteers. We invite you to review the charge for the FACT Standards Committee and either nominate yourself or a colleague to serve as a committee member.
The FACT Standards Committee drafts standards and guidance for cellular therapy product collection, processing, and administration; and cord blood collection, banking, and release for administration, using evidence-based science and considering evolving uses of cellular therapy.
The committee’s goal is to provide clear and user-friendly FACT standards and effective transition between editions of Standards.
- 3 year term
- Minimum of 2 three-month periods with weekly or bi-weekly teleconferences
- Complete initial edits prior to the public comment period
- Review of public comments submitted
- Ongoing participation until the development of the next edition of Standards
The majority of the hard work is completed during subcommittee discussions that take place several months before the actual publication of the Standards. The experience and expertise of our volunteer subcommittee members is invaluable to the development of each edition of Standards.
Standard Development Schedule
FACT currently has four sets of Standards, with multiple subcommittees (e.g., Clinical, Collection, Processing, Quality Management, Immune Effector Cell) under each set. The Standards Development process for each upcoming edition of Standards is below:
- FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (July 2019)
- FACT Standards for Immune Effector Cells (July 2019)
- FACT Common Standards for Cellular Therapies (May 2020)
- NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. (January 2021)
Volunteers are an essential resource for FACT. Our success and accomplishments are directly attributable to the selfless commitment of our knowledgeable volunteers. FACT’s volunteers bring new ideas and energy to the Foundation. Your volunteering makes a difference in the organization and the cell therapy community.
Please submit your interest in serving as a committee member along with a description of your qualifications to Andra Moehring, FACT Standards Development Manager, at email@example.com by May 1, 2019.
Publication of the FACT Common Standards, Second Edition
By Andra Moehring, FACT Standards Development Manager
Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the FACT Common Standards Steering Committee on publishing the Second Edition FACT Common Standards for Cellular Therapies on March 15, 2019. The Standards will become effective on June 15, 2019.
The Second Edition FACT Common Standards Steering Committee is comprised of 12 representatives who worked for 23 months on the development of the Standards. The committee’s commitment, expertise, and experience is invaluable to the development of these Standards.
The Standards contain important additions and changes to requirements to reflect current processes typical in a cellular therapy program. These changes maintain the relevance of the Standards in the field of cellular therapy.
Public Comment Period
During the 60-day public comment period, 240 comments were submitted by 19 contributors. The committee was responsive to public comments and requests made on behalf of related organizations.
FACT greatly appreciates contributors taking the time to review the draft Standards and submit comments.
Accessing the Standards and Other Resources
The Standards, summary of changes, and crosswalks are available on the FACT website at http://www.factwebsite.org or by using the links provided below:
FACT Common Standards, Second Edition
Purchase Printed Copies
Summary of Changes to FACT Common Standards, Second Edition
FACT Common Standards Crosswalk First to Second Edition
FACT Common Standards Crosswalk Second to First Edition
If you have questions related to the Second Edition FACT Common Standards, contact your FACT Coordinator or submit your questions to firstname.lastname@example.org.
Thank you for all of your contributions!
FACT Standards Development Activities
FACT Common Standards, Second Edition Nearing Publication
The Second Edition FACT Common Standards for Cellular Therapies will be published on March 15, 2019. Once published, the updated Standards, summary of changes, and crosswalks will be available on the FACT website for reference, and printed copies of the Standards will be available for purchase from the FACT store.
The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. In early stage product development and early phase clinical trials, these Standards provide the quality management infrastructure to facilitate patient and data accrual to advance the therapy.
NetCord-FACT International Cord Blood Standards, Seventh Edition Available for Public Review and Comment
The NetCord-FACT Standards Committee completed its initial review of the draft Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.
The draft Standards and accompanying Accreditation Manual are published for inspection and public comment for a 90-day period. Comments will be accepted through April 1, 2019.
These Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.
Description and Instructions for Review and Comment
Draft NetCord-FACT Cord Blood Standards
Draft NetCord-FACT Accreditation Manual
Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form. Comments will be accepted through April 1, 2019.
Standards Committee to Initiate FACT-JACIE International Hematopoietic Cellular Therapy Standards and FACT Immune Effector Standards Development
FACT is creating the Steering Committee and Subcommittees that will develop the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and the Second Edition FACT Immune Effector Cell Standards.
In addition to the existing subcommittees (clinical, collection, processing, and quality management), an immune effector cell subcommittee will be added to the Hematopoietic Cellular Therapy Standards development process to ensure consistency between the two sets of Standards.
Standards development will begin this summer, with the first draft scheduled for public comment in April 2020.
FACT Standards Committee Announcements
The FACT Standards Committees thank you for your continued feedback on FACT Standards during the various steps in the development process. The FACT Common Standards for Cellular Therapies and the NetCord-FACT Cord Blood Standards are currently under revision. Updates for these Standards are provided below. As progress continues, important updates for each set of Standards will be announced via weekly emails and future Just the FACTs newsletters.
FACT Common Standards for Cellular Therapies, Second Edition
The FACT Common Standards Steering Committee completed its review of the 257 public comments submitted on the draft second edition of the Common Standards. Your feedback is greatly appreciated.
The second edition is scheduled for publication on March 15, 2019. These Standards represent the basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials.
NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Seventh Edition
The NetCord-FACT Cord Blood Standards Steering Committee met at the 2018 Cord Blood Connect International Conference in Miami, FL on September 13, 2018 to review the draft seventh edition of the Cord Blood Standards.
On November 30, 2018, the draft seventh edition Standards and accompanying Accreditation Manual will be published for inspection and public comment for a 90-day period. Comments will be accepted from November 30, 2018 through March 1, 2019.
The final Standards will be published in October 2019.
FACT Submits Comments to Governmental Agencies
FACT-accredited organizations are regulated by several governmental agencies around the world in relation to quality and safety of cellular therapy products and reimbursement. When draft regulations or guidance documents are released, FACT committees review the information and submit comments as applicable to the scope of FACT accreditation. In the past decade, comments have been submitted to agencies in the United States, Australia, and Europe. The FACT Global Affairs Committee also supports cellular therapy leaders in developing countries to encourage use of FACT Standards.
So far this year, FACT has submitted comments on three topics to two agencies in the United States:
- Docket No. FDA-2017-D-6154 for “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry”; submitted to the Food and Drug Administration (FDA) on February 9, 2018.
- Docket No. FDA-2017-D-6159 for “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry”; submitted to the Food and Drug Administration (FDA) on February 9, 2018.
- National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers; submitted to the Centers for Medicare & Medicaid Services on June 15, 2018.
FACT also plans to review the recently published FDA draft guidance documents for gene therapies. These comments are due by October 10, 2018. If you have input you would like FACT to consider for inclusion, submit those to Kara Wacker at email@example.com by August 31, 2018.
Cellular Therapy Accreditation Committee News and Notes
Article written by Suzanne Birnley, FACT Accreditation Coordinator
The Cellular Therapy Accreditation Committee reviews Accreditation Reports for programs inspected under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy, the FACT Common Standards for Cellular Therapies, and the FACT Standards for Immune Effector Cells. After review, the committee makes recommendations to the FACT Board of Directors regarding an applicant’s accreditation status.
The first quarter of 2018 has been an exciting and busy one for the committee. Despite no meeting in February due to the BMT Tandem meetings, the committee was still able to review 13 programs for renewal accreditation in January and March 2018. Additionally, the committee reviewed the first program to apply for standalone accreditation under the FACT Standards for Immune Effector Cells.
The following are some notes regarding the function of the Cellular Therapy Accreditation Committee:
- At each meeting, as deficiencies indicate potential needs for revisions or additions to future sets of FACT Standards, the issues are compiled into a list for future review by the Standards Committee. This feedback from the Cellular Therapy Accreditation Committee promotes improvement and greater clarity with each publication of Standards.
- As programs complete the renewal accreditation process, in addition to the inspector’s assessment, they will be reviewed by the FACT-CIBMTR Data Audit Committee and possibly the Clinical Outcomes Improvement Committee. Recommendations related to data management and clinical outcome deficiencies are considered by the Cellular Therapy Accreditation Committee when determining the accreditation outcome for an applicant.
- One of the most commonly cited requirements is validation. A satisfactory validation will include the following at a minimum:
- An approved validation plan, including conditions to be validated
- Acceptance criteria
- Data collection
- Evaluation of data
- Summary of results
- References, if applicable
- Review and approval of the validation plan, validation report, and conclusion by the Quality Manager or designee and the Clinical Program Director/Facility Director or designee
The seventh edition of the FACT-JACIE Standards for Hematopoietic Cell Therapy was published at the beginning of March 2018. Programs must be compliant with this set of Standards by May 30, 2018. It is important for programs to remember that as they add new accredited services, such as immune effector cellular therapy or more than minimal processing, these must be implemented in compliance with the FACT Standards and reported to FACT. Additionally, if your program uses or plans to use contracted services in your organization, you are responsible for notifying FACT and monitoring the accreditation status of those service providers.
New FACT Standards Development Activities
By Andra Moehring, FACT Standards Development Specialist
FACT Common Standards, Second Edition Nearing Public Comment Period
The FACT Common Standards Steering Committee convened at the BMT Tandem Meetings in February 2018 to finalize initial edits to the draft FACT Common Standards, second edition. A draft for public review and comment is scheduled for publication in June 2018.
NetCord-FACT International Standards for Cord Blood, Seventh Edition Development Process Underway
The NetCord-FACT Standards Committee has begun its initial review of the draft NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, seventh edition. The Cord Blood Committee roster can be found on the FACT website.
The NetCord-FACT Standards Steering Committee will complete the draft in September 2018. This draft will be made available for public review and comment.