Audit Tool for Cellular Therapy


  • This audit tool contains interactive and printable checklists that may be used for ensuring compliance with the ISBT 128 Standard.

  • It is not meant to replace the ISBT 128 Standard. Users should not rely entirely upon this audit tool and should use it in conjunction with the ISBT 128 Standard.

  • All examples shown are for illustrative purposes only and meant to provide general guidelines. Actual label information may be different or more detailed.

  • National regulations and appropriate accreditation standards must be consulted to ensure full compliance with requirements.

  • Technical References:

ST-001: ISBT 128 Standard Technical Specification
ST-002: ISBT 128 Standard Terminology for Medical Products of Human Origin
ST-004: ISBT 128 Standard Labeling of Cellular Therapy Products

Please send your comments and suggestions to standards.dev.mgr@isbt128.org.

Audit Tool Instructions for Use.


Audit Tool - ZIP Folder

CLICK HERE to download the Audit Tool ZIP Folder. Please be sure to EXTRACT ALL FILES once the folder is downloaded.