Publication of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy, Seventh Edition
By Andra Moehring, FACT Standards Development Specialist
Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the FACT-JACIE Standards Committee on publishing the seventh edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration on March 1, 2018. The Standards will become effective on May 30, 2018.
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.
The seventh edition FACT-JACIE Standards Committee is comprised of 58 representatives from around the world who worked for 23 months on the development of the Standards. The committee is divided into four subcommittees: Clinical, Collection, Processing, and Quality Management. The FACT Immune Effector Cell (IEC) Task Force was also involved in the development and review of IEC specific requirements. Everyone’s commitment, expertise, and experience is invaluable to these Standards.
The seventh edition of the Standards contains 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 90-day public comment period, 653 comments were submitted by 78 contributors residing in 12 different countries. The committee was responsive to public comments and requests made on behalf of related organizations to ensure the seventh edition is broadly accepted throughout the cellular therapy community.
FACT and JACIE greatly appreciate contributors taking the time to review the draft Standards and submit comments.
Accessing the Standards and Other Resources
The Standards, accompanying Accreditation Manual, summary of changes, and crosswalks are available on the FACT website at http://www.factwebsite.org or by using the links provided below:
FACT-JACIE Hematopoietic Cell Therapy Standards, Seventh Edition
FACT-JACIE Accreditation Manual, Seventh Edition
Changes to Seventh Edition FACT-JACIE Standards
FACT-JACIE Cellular Therapy Standards Crosswalk 6th to 7th Edition
FACT-JACIE Cellular Therapy Standards Crosswalk 7th to 6th Edition
Dr. Eldridge presented a webinar on how to “Effectively Transition to the 7th Edition Hematopoietic Cellular Therapy Standards” on March 14, 2018. Based on the questions received, a question and answer document was created to assist those who were unable to attend. If you were unable to attend the webinar, you can purchase the recording. FACT inspectors may download the recording for free!
If you have questions related to the seventh edition FACT-JACIE Standards, contact your FACT Coordinator or submit your question to firstname.lastname@example.org.
Thank you for all of your contributions!