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8th edition of the FACT-JACIE Standards

by Eoin McGrath
JACIE Committee

8th edition of the standards published 17 May 2021

The following documents can now be downloaded from the 8th edition Standards page:

  • Standards
  • Manual
  • Crosswalks (mapping of references in respective editions)
    • 7th - 8th
    • 8th - 7th
  • Summary of main changes
  • JACIE comparison table: 7th to 8th editions

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.

Key dates

The following dates are important for applicants planning to apply in 2021:

  • 17/05/2021 - The 8th edition of the FACT-JACIE Cellular Therapy Standards, Accreditation Manual, Checklist and associated documents published jointly by FACT and JACIE.
  • 16/08/2021 - Effective date of 8th edition. Earliest date for applications to be accepted under the new edition.
  • 31/12/2021 - Final date for sending completed applications to JACIE based on the 7th edition of the FACT-JACIE Standards. All applications after this date must be made under the 8th edition.
  • 01/03/2022 - Final date to submit the complete pre-audit documentation under the 7th edition. Any centre that fails to submit all pre-audit documentation by this date will have to restart the application process under the 8th edition of the Standards and submit a new application.

Centres already accredited will not have their accreditation affected. For interim audits, centres will be assessed on the same standards as used for the main inspection. However, all centres are expected to adapt their processes and systems to the requirements of the 8th edition. 

8th edition of FACT-JACIE Standards - Public review of draft 8th ed. FACT-JACIE Standards open

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for public comment. Comments regarding the draft Standards can be submitted by accessing the Comment Form.

The draft contains significant additional standards relevant to risk management plans for licenced or authorised cellular therapies products. A comprehensive summary of changes is available here along with instructions for participating in the public review process.

Deadline 30 August 2020.

Second Standards Steering Committee, 16-17 February 2020

The FACT-JACIE Standards Steering Committee met on 16-17 February in Orlando, USA on the occasion of the TCT congress. 9 FACT and 4 JACIE representatives reviewed the draft text that emerged from the sub-committee phase.

The format of the meeting was extended from 1 day as for previous editions to 1.5 days which allowed for more in-depth discussion and the line-by-line review during the meeting exposed several cases of duplication or repetition which are expected to be better managed.  

Overall, no substantial changes are expected in the format of the Standards while the Manual is expected to see changes in the layout in order to add more clarity and provide more examples.

Andra Moehring, the FACT Standards Manager, is now preparing the final draft which will be opened to public consultation between April and June 2020. As always, stakeholders are strongly urged to participate in the consultation and make their views heard.

A session on the Standards will be included in the EBMT 2020 Annual Meeting in Madrid within the Quality Management track on Tuesday 24 March. See the programme for more information.

Standards committee Orlando

From left to right: Lizette Caballero, Nina Worel, Helen Heslop, Joseph Schwartz, Michele Sugrue, Eoin McGrath, Phyllis Warkentin, Ivan van Riet, Olive Sturtevant, Paul Eldridge – Chair, Demetrios Petropoulos, Kim Orchard 

Preparation of the 8th edition of the FACT-JACIE Standards kicks-off, 2 July 2019

The review process to prepare the 8th edition of the Standards kicked-off in Barcelona on 2 July with committee members from JACIE and FACT present. There is a wealth of experience among the committees, not just as experts in transplantation and cell therapy, but also in the development of the Standards as all have participated in previous review processes.

The process is being coordinated by the FACT Office who will support the sub-committees throughout the process. The JACIE Office will also be available to provide additional support where necessary. In terms of contents, there was a broad consensus on the need to avoid unnecessary repetition and among other initiatives will be to improve the Accreditation Manual to make it more accessible. See also the report on the pre-review survey below.

The sub-committees will start their teleconferences in late August or September and work through their respective Parts until late 2019 following which a first draft will be prepared and presented for public consultation in April 2020 in line with previous editions.

The JACIE co-chairs are Kim Orchard (Southampton, UK) for Clinical, Nina Worel (Vienna, Austria) for Collection, Ivan van Riet (Brussels, Belgium) for Processing and Simon Hack (London, UK) for Quality Management. A fifth sub-committee for Immune Effector Cells will also be included in this edition and the JACIE representatives are currently being recruited to joint their FACT counterparts.

FACT-JACIE Steering Committee Meeting 02072019 Barcelona-Group photo
FACT-JACIE Steering Committee Meeting 2nd July 2019 in Barcelona

Andra Moehring, FACT Standards Development Manager, says: “Thank you all so much for the great discussions at today's meeting! It was wonderful seeing many of you again, and meeting some of you for the first time. A special thank you to JACIE for hosting us. Barcelona is my favorite place to visit. “

8th edition FACT-JACIE Standards – Feedback

The pre-review survey was the best-supported to date with 106 total survey respondents. The following countries were represented:  Argentina, Australia, Austria, Belgium (4), Canada (6), Finland, Germany (3), Greece, Indonesia, Ireland (3), Italy (2), Netherlands (2), Qatar, Saudi Arabia (2), Singapore, Spain (4), UK (10), Uruguay, US (61) while the breakdown by work area was Clinical (41), Collection (32), Processing (38), and QM (77).

The responses covered from the general to the specific with particular focus on the quality management standards and immune effector cells among others. The survey feedback will be provided to the respective sub-committees for consideration during their reviews.

Thank you to everyone who took the time to complete the survey.