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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 ISBT128 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 become effective March 30, 2023.  All organizations accredited under these Standards are expected to be in compliance with the requirements by that date.  Compliance Applications under the Common Standards will now only be accepted for the third edition. For organizations currently pursuing accreditation under the second edition, all inspections must be scheduled before the effective date. All inspections scheduled after this date will be under 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
Download additional supporting documents

NEWS RELEASE: FACT Announces King Abdulaziz Medical City as first Cellular Program in Saudi Arabia to earn FACT Accreditation

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NEWS RELEASE
Issued: April 13, 2022
Contact: Linda Miller

OMAHA, Neb. – King Abdulaziz Medical City – Riyadh, Saudi Arabia received internationally recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT). Directed by Mohsen Alzahrani, MD, it is the first and only cellular therapy program in Saudi Arabia to be recognized by FACT. The program received accreditation on July 1, 2022, and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Trans-plantation, Marrow and Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.
Read full news release

NEWS RELEASE: FACT Announces New Website and Branding

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NEWS RELEASE
Issued: April 13, 2022
Contact: Linda Miller

OMAHA, Neb. — Foundation for the Accreditation of Cellular Therapy (FACT), the leader in voluntary inspection and accreditation in the field of transplantation and cellular therapy, announces its new website and branding launch.
Read full news release

NEWS RELEASE: FACT Takes First Step in Transition With New Email Domain and Phone Numbers

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NEWS RELEASE
Issued: October 25, 2021
Contact: Linda Miller

OMAHA, Neb. — FACT is pleased to announce the first step in efforts to transition to an enhanced website with the establishment of a new email domain and phone numbers.
Read full news release

FACT Common Standards Available for Public Comment

The draft third edition FACT Common Standards are available for review and comment through October 1, 2021.
Read the draft Standards, Summary of Changes, and instructions for submitting comments.

Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards are Now Available

The eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying eighth edition Hematopoietic Cellular Therapy Accreditation Manual have been officially published.

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 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

NEWS RELEASE: FACT Pursues Independent Operational Status

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NEWS RELEASE
Issued: October 25, 2021
Contact: Linda Miller

OMAHA, Neb. — The Foundation for the Accreditation of Cellular Therapy (FACT) is pursuing an opportunity to establish independent operational functions by the end of 2021 thus ending the 25-year collaborative relationship with the University of Nebraska. Read full release

ICCBBA Releases Registration License Fee Flyer for ISBT 128

To assist entities with determining ISBT 128 registration fees, ICCBBA created a registration license fee flyer.
View the flyer.

FACT Announces Accreditations in October and November 2020

In October and November 2020, 11 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

FACT Announces Accreditations in September 2020

In September 2020, five entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

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