Accreditation Programme Status:
Total centres registered: 131
Centres in progress: 38
Centres inspected: 93
Facilities accredited: 53*
Reaccrediations in progress: 5
Countries:13 * Individual facilities e.g. laboratory, apheresis unit, that formed part of a wider application may subsequently be accredited separately for services to other centres |  |
28 April 2008 Due to the high level of interest expressed in the Quality Management Guide, 1st edition, 2008, printed copies are no longer available. However, the document is now available in PDF format. Please go the Surveys section of this web site (on the left-hand side) and click on the second survey -'Quality Mgt Guide Request Form'. On completion of the form, we will send you the PDF as an attachment by email.
By you completing the form, we will also be able to keep your details on file so that you can be advised of any updates or new editions. 9 April 2008 The Accreditation Checklist which includes the self-check by the application centre and the vertification by the inspector was formally made available in Word and PDF formats. These have now been replaced by an Excel file called "0 JACIE Inspection Checklist 3 ed.xls" which can be downloaded from the Docoument Centre on the left-hand side of the web page.
The Excel format allows for a smaller file, the use the Excel filters for speedier checking of answers, and for applicants to include explanatory information beside their answers. The inspectors will also now use the file for writing their inspection report and ensuring that all questions are answered and commented.
The document is a work-in-progress and any feedback is appreciated. Please send your comments or requests for help to jacie@ebmt.org. 7 April 2008 A Centre Preparation Training Course will take place in Athens, Greece on June 23-24, 2008. The course is aimed at centres currently implementing quality management in their centres and preparing for JACIE Accreditation. For further information, please contact the JACIE Office at jacie@ebmt.org or telephone +34 93 454 9543. 5 December 2007: Accreditation Manual, 3rd. edition released The 3rd edition of the Accreditation Manual including Guidance is now available for download from the Document Centre on the left-hand side of the screen. The document is listed as 1 Guidance Final Version.Dec.04.07.pdf. This manual is intended to accompany the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration, Third Edition. The purpose of the Manual is to provide guidance to applicants for accreditation and to on-site inspectors and to explain the intent and rationale for specific Standards, and to provide explanations, examples and alternative approaches that will be helpful in the accreditation process. Note: when downloading the files, right-click with your mouse and select the option to save the file to your computer. 26 October 2007: Standards reference numbers: Part D A minor error was found under Part D of the JACIE release of the Standards. Reference D11.3.3 featured as D11.3.2.3. The text is unaffected and the reference appeared correctly in the Inspection Checklist. The corrected version of the 3rd edition of the Standards is now available on the JACIE web site. In addition, FACT-JACIE has updated the requirements for labelling Cellular Therapy Products. This replaces the information found in the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration, Appendix I, Cellular Therapy Product Labelling Table. The table has been adjusted slightly to (1) include "AF" for Product Modifiers under Partial Label and (2) to alter the requirements for inclusion of 'FOR AUTOLOGOUS USE ONLY'. (3) Other slight changes are formatting only and do not impact on the labelling requirements. The amended table is included in the Standards document available in the Document Centre. | 
