Reminder! Input Requested on FACT Standards
Comments Requested on Draft Second Edition FACT Standards for Immune Effector Cells
FACT published the draft second edition FACT Standards for Immune Effector Cells for public comment during a thirty-day period. Comments will be accepted through April 30, 2023.
To access the draft Standards and submit public comments, visit the Public Comments webpage on the FACT website.
FACT-JACIE Standards Feedback Requested
Preparation of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, ninth edition, will commence in May 2023. Final publication is expected in early 2025.
FACT and JACIE invite you to complete a short survey to provide feedback and suggestions regarding the Standards. Survey results will be reviewed by the Standards Steering Committee for potential inclusion in the next edition of the Standards. Responses will be accepted through April 28, 2023.
HCT Accreditation Manual Provides Additional Examples of Proof of Death
Standard D12.1.3.1 of the FACT-JACIE Hematopoietic Cell Therapy Standards1 requires proof of death of the intended recipient of any hematopoietic progenitor cell (HPC) product before it is discarded. Many cellular therapy programs noticed an additional sentence added to the examples in the accompanying Accreditation Manual2:
Eighth Edition Standards:
D12.1.3 Documentation of no further need for the cellular therapy product before any product is discarded.
D12.1.3.1 For HPC products, this shall include documentation of the designated recipient’s death, if applicable.
Examples in the Eighth Edition Accreditation Manual:
FACT Seventh Edition: Proof of death includes an autopsy report, a dictated clinical note, or the Social Security index in the U.S. Secondary sources of information, such as newspaper articles, do not satisfy this requirement.
FACT Eighth Edition: Proof of death includes an autopsy report, a signed statement by the treating physician, or the Social Security index in the U.S. The institution registry or the governmental regional registries are also adequate sources. Secondary sources of information, such as newspaper articles, do not satisfy this requirement.
The Standards Committee’s intent is to no longer require the Processing Facility to obtain primary documentation of death for every discarded cellular therapy product. As stated in the Explanation, the facility may use an institutional process for documentation of death, such as having the patient listed as deceased in the electronic medical record. However, the institutional process must be based on primary documentation. Examples of acceptable primary sources are a death certificate, death at the institution, or the Social Security Index. The facility may consider doing a process validation of the institutional process to document death and confirm that it is based on a primary record. This confirmation would only need to be performed as part of the validation and not for every death record that the facility obtains.
The institutional cancer registry worksheet would suffice for the Processing Facility’s records, as long as the facility has confirmed that the registry’s process for noting death does include a primary source.
The term “governmental regional registries” was included at the request of international groups, and would include death registries maintained by states.
Most informed consent processes now state a time limit for how long a cellular therapy product will be stored, or when a product will be moved to long-term storage. For informed consent that states that products will be stored until death, FACT recommends that the Processing Facility consults with its legal department if it desires to dispose of the product.
[1] FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition, Version 8.1
[2] FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual, Eighth Edition, Version 8.2
Comments Requested on Draft Second Edition FACT Standards for Immune Effector Cells
The Foundation for the Accreditation of Cellular Therapy (FACT) will publish the draft second edition FACT Standards for Immune Effector Cells on March 31, 2023, for public comment during a thirty-day period. Comments will be accepted through April 30, 2023.
These Standards promote quality practice in immune effector cell therapies and apply to a wide range of immune effector cells used to modulate an immune response for therapeutic intent, whether genetically modified or not. This includes, but is not limited to, dendritic cells, natural killer cells, T cells, B cells, genetically engineered chimeric antigen receptor T cells (CAR-T cells), and therapeutic vaccines. The final Standards will be published in November 2023 and will become effective in February 2024.
The FACT Standards for Immune Effector Cells were reviewed and commented upon during an initial public comment period in association with the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. The majority of comments received have been addressed through harmonizing these two publications.
Comments submitted during the first comment period clearly indicated a need to enhance standards related to cell collection. These comments have been addressed in B2.12, B2.12.1, and in a reorganized Section C that now includes general standards applicable to any cell collection followed by sections C9, C10, and C11 specific to apheresis and whole blood collection, marrow collection, and collection of other tissues such as tumor-infiltrating lymphocytes (TILs).
The purpose of this comment period will be to specifically request your comments on these new sections. Two versions of the published draft are available. One is a clean version, and the other is a redline document intended to highlight the changes made to these Standards. Minor reorganization and clarifying changes are not tracked. Some changes are new standards; however, some are intended to clarify rather than to change the intent. In addition, many changes were made to provide consistency among all sets of FACT Standards:
- Draft Second Edition FACT Immune Effector Cells Standards
- Draft IEC Redlined Document
- Visit the FACT IEC RedCap Survey for instructions and to submit your comments
If you have any questions, please contact Monique Summers, FACT Standards Development Manager at monique.summers@factglobal.org or 402-920-7010.
FACT-JACIE Standards Feedback Survey
Preparation of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, ninth edition, will commence this summer. Final publication is expected in early 2025.
FACT and JACIE invite you to complete a short survey to provide feedback and suggestions regarding the Standards. Survey results will be reviewed by the Standards Steering Committee for potential inclusion in the next edition of the Standards.
You are also encouraged to share the survey with your colleagues and promote the survey in your professional societies. Responses will be accepted through April 28, 2023.
If you have any questions or need additional information, please contact the Standards Development Manager at Monique.Summers@factglobal.org.
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
FDA Publishes Draft Guidance on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
The United States Food and Drug Administration (FDA) is responding to needs for regulatory predictability and leverage of stakeholder efforts for standardization in regenerative medicine therapies, including cellular therapy, via a draft guidance that introduces a voluntary consensus standards recognition program.
Published in June 2022, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies: Draft Guidance for Industry acknowledges many unique challenges caused by the novelty of regenerative medicine therapy products. The proposed standards recognition program for regenerative medicine therapies (SRP-RMT) is intended to:
- Use agency expertise to evaluate and recognize voluntary consensus standards.
- Provide transparency to industry and other stakeholders regarding CBER’s thinking about a particular method or approach.
- Promote the visibility and use of standards applicable to the agency’s mission.
The draft guidance describes the purpose of the program, procedures for evaluating standards for recognition, documenting the use of a recognized standard, and questions and answers.
Comments on the draft guidance are due by September 14, 2022. Comments may be submitted to https://www.regulations.gov, Docket No. FDA-2022-D-0745-0001.
A public workshop to discuss the guidance will be hosted by the Standards Coordinating Body (SCB) free of charge on August 24, 2022 at 12 pm ET. Register online.
Standards Development Updates
By Monique Summers, RN, MSN, MPA
FACT Standards Development Manager
Standards Committee members have risen to the challenges of COVID-19 over the past two years, and all four sets of FACT Standards have been in the active phase of the review process. Members have incorporated feedback from constituents, discussed new developments in cellular therapy, and edited drafts. Updates for each set of Standards are provided below. As progress continues, important updates will be announced.
FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition
FACT and JACIE finalized the eighth edition Hematopoietic Cellular Therapy Standards in August 2021 with a revision in December 2021. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, cord blood, or other tissues and administered by a blood and marrow transplant (BMT) team.
The FACT Accreditation Services department is working with accredited and applicant programs that are beginning the accreditation process under the eighth edition and is available for questions.
FACT Standards for Immune Effector Cells, Draft Second Edition
The FACT Standards for Immune Effector Cells apply to immune effector cellular (IEC) therapy programs that are independent of a transplant program. Standards specific to IEC therapy are also contained within the FACT-JACIE Hematopoietic Cellular Therapy Standards for programs that perform both transplant and IEC therapy. To ensure that the Standards reflect emerging changes in the field, FACT delayed the publication of the second edition to incorporate the expertise of providers with Tumor Infiltrating Lymphocyte (TIL) experience. The committee has resumed its work and plans to publish the draft for a second public comment period in late 2022.
FACT Common Standards for Cellular Therapies, Draft Third Edition
The draft third edition FACT Common Standards for Cellular Therapies was published in 2021 for public comment. The Common Standards Committee consists of members representing a wide variety of specialties to ensure the Common Standards continue to represent the basic fundamentals applicable to any type of cellular therapy. This includes HPC transplantation, IEC therapy, cardiovascular medicine, cord blood banking, cell collection, and cell processing with minimal and more-than-minimal manipulation. The third edition is scheduled to be published soon.
NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Draft Eighth Edition
The Steering Committee kicked off the drafting of the eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration in May 2021, and subcommittees have been meeting for the past year. The Steering Committee will meet during the 2022 Cord Blood Connect meeting in Miami, Florida to complete a final review of the draft prior to public comment, which is scheduled for late 2022.
Examples of Label Reconciliation Methods to Prevent Mix-Ups of Cellular Therapy Products
Label reconciliation is now required in the eighth edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Specifically, Standards CM7.2.2.1, C7.2.2.1, and D7.2.3 state: “A system of label reconciliation shall be used to ensure the final disposition of all labels allocated to a specific product is documented.”
The purpose of this requirement is to prevent cellular therapy product mix-ups. As the FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual states, “The purpose of reconciliation is to ensure that all labels have been accounted for and no mix-up occurred. A system for label reconciliation that documents the number and type of labels received by the Collection/Processing Facility, the number of labels used, and the number of labels passed to the Processing Facility or destroyed shall be used.” The scope includes labels with unique identifiers of final products. It does not include labels for patient demographics or internal tracking numbers if they are not uniquely identifying a product, though these labels must still be controlled.
Print-on-demand systems for labels reduce risks of label mix-ups; however, there are instances in which a batch of labels is printed to facilitate processes. Label reconciliation does not need to be performed in real-time but should at least occur at the end of a process (for example, during cleanup of a processing procedure.)
In addition to the labeling operations requirements outlined in the FACT Coding and Labeling Cellular Therapy Products sections of the Standards (CM7, C7, D7), the following are example methods that may facilitate label reconciliation:
- Keeping labels in a batch record.
- Limiting the number of labels that are printed at a given time, and defining in policies what the use of each label will be.
- Utilizing a form that details the number of labels printed or received, used, passed to another unit, or destroyed. This could be on a collection form or a separate label reconciliation form.
- Affixing unused labels to the relevant form and crossing through or annotating labels that will no longer be used.
- Numbering labels (e.g., for 12 labels, label them 1 of 12, 2 of 12, and so on) to facilitate documentation of which label was used where.
Updated Versions of FACT-JACIE Hematopoietic Cellular Therapy Standards and Accreditation Manual Available
The Eighth Edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been updated to Version 8.1, and its accompanying Hematopoietic Cellular Therapy Accreditation Manual has been updated to Version 8.2.
Version 8.1 of the Standards became effective on January 14, 2022. The changes from Version 8.0 to 8.1 are clerical in nature, and organizations accredited under these Standards should already be in compliance. Most of the changes in the Accreditation Manual from Version 8.1 to 8.2 are also clerical. Substantive content changes to the manual reaffirm and clarify donor screening and donor lymphocyte infusion (DLI) eligibility requirements. Reference Appendix V in both documents for a summary of the changes.
The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products.
FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
Download the updated Standards, Manual, and Summary of Changes
Purchase printed copies of the 8.1 Edition FACT-JACIE Standards
Purchase printed copies of the 8.2 Edition Hematopoietic Cellular Therapy Accreditation Manual
FACT and JACIE Remained Committed to Publishing the Eighth Edition Hematopoietic Cellular Therapy Standards Despite Worldwide Pandemic
As an international Standards Committee, the FACT-JACIE Hematopoietic Cellular Therapy (HCT) Standards Committee is accustomed to remote collaboration. Its ability to work primarily online was brought to the test during the COVID-19 pandemic in 2020, and the committee rose to the challenge! The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021.
“Even with the challenges of a pandemic combined with very rapid advances in the field, amiable dedicated colleagues allowed successful completion of the task,” says Dr. Paul Eldridge, Chair of the Standards Committee. “I want to express my thanks and gratitude to everyone.”
Dr. Kim Orchard, Co-Chair of the Clinical Standards Subcommittee, adds, “The preparations for the eighth edition of the Standards proceeded with only minimal delays due to the COVID-19 pandemic. Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”
“It was a challenge to continue with everything during the pandemic,” according to Dr. Nina Worel, Co-Chair of the Collection Standards Subcommittee. “Not so much with the FACT-JACIE team working on the eighth edition as the time schedule is perfect. We are used to working remotely and the meetings always close on time, but this time there were a lot of other additional meetings that were remote.”
“We managed to have the second face-to-face meeting of the combined FACT and JACIE teams just before the full impact of the first wave occurred, and all subsequent meetings were held by remote means which were already planned,” says Dr. Orchard. “Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”
The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
The HCT Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and immune effector cell (IEC) requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards.
Following months of initial reviews and revisions, the HCT Standards Committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period. Additionally, other experts from FACT and JACIE participated in discussions related to new developments in the field, including Dr. John Snowden, member of the JACIE Committee and secretary of the European Society for Blood and Marrow Transplantation (EBMT), the FACT Immune Effector Cell Task Force, and others. These experts provided the HCT Standards Committee advice to consider when finalizing the Standards, with revisions ultimately drafted by the Standards Committee and approval granted by the FACT and EBMT Boards of Directors.
“It was really exhausting [with the other remote meetings]. However, we managed to finalize a great new edition of Standards for best quality in cellular therapy for our patients,” says Dr. Worel.
“It was a pleasure to work with committee members on the new edition of standards,” says Dr. Eldridge. “The opportunity to learn from such a diverse group of international experts is amazing.”
The eighth edition Standards become effective on August 16, 2021. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Although there may be a few inspections remaining to be completed under the previous edition due to COVID 19-related delays, all other inspections scheduled after this date will be under the eighth edition.
Review the Summary of Changes for the eighth edition FACT-JACIE Standards
Download the eighth edition FACT-JACIE Standards for free
Download the eighth edition Hematopoietic Cellular Therapy Accreditation Manual for free
Purchase printed copies of the eighth edition FACT-JACIE Standards
Purchase printed copies of the eighth edition Hematopoietic Cellular Therapy Accreditation Manual
Download additional supporting documents
The X Factor: What is GxP and What Training is Required?
The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration requires that physicians and staff have annual training in current GxP appropriate to the processes performed in accordance with Applicable Law. (See Standards CM3.3.4, C4.4.2.5, and D4.4.2.5).
What is GxP?
The Standards define GxP as, “Good practice following various quality standards and regulations. The “x” is variable, with further definition of good practices defined by different Applicable Law and industry standards. The type of work that is being performed will define which GxPs should be followed.”
Different facilities will follow different GxPs based on the activities they perform. These may include, but are not limited to, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), Good Documentation Practices (GDPs), Good Clinical Practices (GMPs), and Good Laboratory Practices (GLPs).
What GxPs require annual training per the Standards?
FACT requires training in all GxPs that are required by law. Accredited facilities must determine which GxPs apply to the activities they perform and for the types of cellular therapy products for which the cells will be used. This includes an assessment of all activities and determination of which GxPs are required by law for each of those activities. Facilities must document this assessment so 1) the program has a defined list of GxPs that require training and 2) inspectors can verify appropriate training is performed.
All Apheresis Collection and Processing Facilities will have activities applicable to GTPs and GDPs. All Marrow Collection Facilities will have activities applicable to GDPs, but may also perform activities related to GTPs. Collection and Processing Facilities may also need to follow GMPs, GCPs, or GLPs. The extent and level of GMPs implemented is dependent on the type of manufacturing that is performed (e.g., manufacturing of allogeneic minimally manipulated HPC cellular therapy products verses investigational and licensed cellular therapy products).
How much training is required each year?
Comprehensive training on every aspect of GxPs each year is not expected; rather, there must annually be some training based on a GxP topic.
Many of the procedures performed by personnel already require training in GxPs to perform the work; therefore, GxP training is not required to be separate. However, documentation must provide evidence that the GxPs were included. For example, training in environmental control could include an overview of GTPs or GMPs, the relevant requirements based on the work to be performed, and the specific tasks performed by personnel.
Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards
Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual
Navigating the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards Webinar
The eighth edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards was published on May 17, 2021 and will be effective on August 16, 2021. To support FACT accredited and applied programs during this transition, FACT is offering a webinar, titled Navigate the Eighth Edition Cellular Therapy Standards, on July 21, 2021 at 10 am CT, 3 pm GMT. Dr. Paul Eldridge from Levine Cancer Institute, the Standards Committee Chair, will explain changes including:
- Genetically-modified cellular therapy products
- Training in GxP
- Quality management
- Informed consent
- Labeling
- Storage
FACT-JACIE Hematopoietic Cellular Therapy Standards to be Published in May
The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is finalizing the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (HCT Standards). The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.
FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells. Publication of these Standards is planned following publication of the HCT Standards. This change in schedule will allow FACT to place priority on updating related accreditation documents for programs accredited under the HCT Standards, whose inspections were disproportionally affected by COVID-related delays.
Eighth Edition NetCord-FACT Cord Blood Banking Standards Development Begins
The eighth edition of the NetCord-FACT Cord Blood Banking Standards is officially in development under the leadership of FACT’s new Standards Committee Chair, Dr. Nicole Prokopishyn. The Cord Blood Standards Steering Committee kicked off the process on April 22, 2021.
Any suggestions or comments regarding the Cord Blood Standards are welcome. Please provide feedback to FACT’s new Standards Development Manager, Monique Summers, at monsummers@unmc.edu.
New Chair of Standards Development Announced
The FACT Board of Directors is pleased to announce the appointment of Dr. Nicole Prokopishyn to serve as the next Chair of Standards Development beginning with the 8th Edition of Cord Blood Standards slated to kick off in Spring 2021. Dr. Prokopishyn currently serves as the Cellular Therapy Lab Director at the Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children’s Hospital, Tom Baker Cancer Centre, and Calgary Laboratory Services, and has several years of experience serving as a member of the Standards Committee.
Dr. Prokopishyn follows the dedicated leadership of Dr. Paul Eldridge, who chaired the Standards Committee during the review and updating of each set of Standards. Thank you for your valuable contributions, Dr. Eldridge!
New Editions of FACT-JACIE Hematopoietic Cell Therapy and FACT Immune Effector Cell Standards to be Published in May
The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is completing the final review of the draft eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells.
FACT thanks the many participants of the public comment period for providing useful feedback on the drafts. Approximately 770 comments, submitted by 78 participants from 20 countries, enriched the Standards development process and edits have been made in response when appropriate. FACT will provide a response to comments at the time of final publication of the Standards.
The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.
Standards Coordinating Body Requesting Feedback on Needed Standards: Comments Due November 6
The Standards Coordinating Body (SCB) is seeking input from the regenerative medicine community to update its report: Community Perspectives: Needed Standards in Regenerative Medicine. The content and potential impact of this report on the development of future standards may impact FACT stakeholders, and we encourage volunteer inspectors and personnel from accredited organizations to complete the survey. The survey will be available until November 6, 2020 at 12 pm Eastern Standard Time.
Per the SCB, this report, “is intended to align community efforts around the standards that could have the greatest benefit to the regenerative medicine field and improve the safety and quality of regenerative medicine products. Your input will ensure that the report reflects the current needs and perspectives of stakeholders in the community, helping to direct time and resources toward the highest-priority standards.”
