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AUDIT TOOL FOR CELLULAR THERAPY

INTENDED AUDIENCE:


This tool is intended for auditors to help them assess compliance to ISBT 128 requirements for cellular therapy products. The audit tool can also be used by facilities wanting to perform a self-assessment or a gap analysis as part of their ISBT 128 implementation efforts.

  • 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

INSTRUCTIONAL VIDEO: