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FACT Update: March 2023

  


by
Whitney Fritzinger, MBA, Education and Training Coordinator
Foundation for the Accreditation of Cellular Therapy (FACT)
Omaha, NE USA

FACT Publishes Third Edition of the Common Standards for Cellular Therapies with a New Accompanying Accreditation Manual

Monique Summers, RN, MSN, MPA, Standards Development Manager

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


A New Version of FACT’s Accreditation Portal is Here!



It’s here! FACT has launched a major FACT Accreditation Portal upgrade.

New user How-To Guides are available to assist in navigating the upgraded portal’s new features.  Your username and password will not change.  Your Accreditation Coordinator is a valuable resource for any questions.

Accreditation Portal Open House

To help with transitioning to the upgraded portal, FACT hosted an Accreditation Portal Open House at the 2023 ASTCT Tandem Meetings in Orlando, Florida.  FACT’s Director of IT Services demonstrated the new features in an open forum.  Additional information about future portal training including times and location will be announced on the FACT website and distributed to FACT’s email subscriber list .

FACT Hosted Focus Group at Advanced Therapies Week to Unveil New Assessment Services, Obtain Feedback

Industry representatives, including biotechnology and pharmaceutical companies, multistakeholder groups, and collaborative societies, were invited to an Industry Assessment Focus Group session on January 19, 2023 during Advanced Therapies Week in Miami Beach to participate in the design of an assessment service provided by FACT.

As reported extensively, the current industry qualification and auditing approach for cellular therapy treatment and starting material collection network sites is unsustainable for product manufacturers, health care institutions, and patients. FACT is establishing assessment services designed to optimize patient care and access to cellular therapy by providing an unbiased, unified auditing system applicable to quality, operational, and regulatory requirements of any stakeholder.

Through FACT, sites will receive support to address commonly encountered quality issues. Assessment services will include assessment of site readiness to participate in cellular therapy, verification of quality systems in compliance with regulations, surveillance of operational compliance for company-specific cellular therapy products, and, when relevant, coordination with FACT accreditation inspections. When needed, FACT can also assist sites with compliance gaps prior to qualification.

FACT auditing services will be implemented in addition to existing FACT accreditation and will focus on three primary goals:

1)    Rapidly assess collection and treatment sites’ ability to participate in sponsors’ networks to increase patient access to cellular therapy.

2)    Perform audits on behalf of industry to verify, improve, and maintain quality, operational, and regulatory compliance.

3)    Reduce the duplicative audit burden to redirect workforce and financial resources to patient care and product manufacturing.

During this focus group session, FACT described the types of assessments and related deliverables that we plan to offer to industry. Participants provided actionable feedback that FACT will use to build the service around the needs of industry and health care sites. We look forward to sharing more details about this new assessment service in the coming weeks. In the meantime, inquiries about the service can be directed to Liz Ferraro, Manager of FACT Assessment Services, at liz.ferraro@factglobal.org.



Join the 2023 FACT Education Tour!

FACT invites you to come with us on the 2023 Education Events Tour! Our 2023 education offerings include accreditation workshops, inspector training courses, and quality boot camps. These events are open to current and aspiring accreditation programs, FACT inspectors and trainees, quality personnel, and industry representatives. No matter your interests or where you are in your accreditation journey, we have an event that’s right for you!

Visit our website to view all of our education offerings:

https://www.factweb.org/forms/MeetingCalendar/



We invite you to attend the Apheresis Collection and Processing Accreditation Virtual Workshop on Wednesday, April 19, 2023, from 7:30 am to 5:00 pm. Whether in-person or virtual, FACT’s Accreditation Workshops make learning about the accreditation process and the Standards, an up-close and personal experience. Accreditation Workshops are collaborative events where you will be able to work through a series of scenario-based case studies supplemented with presentations facilitated by experienced FACT instructors.

The Apheresis Collection and Processing Accreditation Virtual Workshop, provides a high-level overview of topics including requirements and expectations for accreditation, how to position your organization to pursue Accreditation, and the most commonly cited Standards. Additional areas of discussion include labeling and chain of identity and custody for IEC products in collected in apheresis facilities and growing variations in collection requirements. 

Book your ticket now! 

FACT’s IEC Webinar Series Continues in March 2023

Quality Immune Effector Cellular Therapy for the Treatment of Solid Tumors Webinar:

CAR-T cells and T-cell Receptor Cells in Solid TumorsThursday, March 30, 2023, | 11:00 am ET

CAR-T and TCR cell therapy has demonstrated encouraging potential for the treatment of solid tumors. During this webinar, presenters will highlight current clinical experience with CAR-T cells in solid tumors and unique considerations in manufacturing. Presenters will also discuss the need for establishing safety and efficacy quality benchmarks for CAR-T cells and TCRs.

Register Now!


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