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5th edition FACT-JACIE International Standards - new applications

posted 25 Jan 2012, 09:32 by Eoin McGrath   [ updated 9 Jul 2015, 01:24 ]
The 5th edition FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration is nearing completion. The following are important dates for cellular therapy programs to remember:

  • 5th Edition Publication Date: 01/03/2012
    The final version of the 5th edition Cellular Therapy Standards will be officially published on 01/03/2012.This includes the Accreditation Manual and associated documents.
  • 5th Edition Effective Date: 31/05/2012
    The 5th edition Cellular Therapy Standards will be effective from and including 31/05/2012. All applications after this date will be assessed according to the 5th edition.
Taking into account the following aspects,

  • the publication and implementation dates
  • that JACIE requires the Inspection Checklist to be submitted along with the Application Form
  • that the 5th edition checklist will not be available until March 1st 2012
  • that JACIE Accreditation Office wishes to draw a clear line between the 4th and 5th editions in order to minimise confusion and overlap of different versions of Inspections for inspectors and centres,
the following dates should be noted by centres that expect to apply within the next 2-3 months.

  • 31/12/2011 - Final date for acceptance of applications based on the 4th edition of the JACIE Standards
  • Between 01/01/2012 - 28/02/2012 inclusive - No new applications accepted.
  • 01/03/2012 - Earliest date for accepting applications and checklists based on the 5th editions
All centres that have already applied with the 4th edition of the JACIE Standards and are in the process of preparing for the JACIE Inspection must submit the pre-audit documentation before 01/04/2012. All centres that do submit the pre-audit documentation on or after 01/04/2012 will have to restart the application process against the 5th edition of the Standards and submit a new application. Given the effort required to prepare for the inspection, please consider carefully your timing for submission of documentation and completion of the Inspection Checklist.