Article: Our FACT-JACIE Standards Compliance

By Simon Ellison |

FACT-JACIE Standards are designed to provide minimum guidelines for programs, facilities, and individuals performing cellular therapy or providing support services for such procedures. It is the responsibility of these organisations and individuals to ensure that all areas comply with the standards.

Relevant Standards
  • FACT: Foundation for the Accreditation of Cellular Therapy
  • JACIE: Joint Accreditation Committee
  • FACT-JACIE: International Standards for Hematopoietic Cellular Therapy (Product Collection, Processing and Administration) 7th Edition
Applicability

World Courier as a transport provider is not eligible to be certified under these standards. However, as there are sections that focus on Product Transportation and Shipping, a gap analysis was conducted to confirm that World Courier is compliant with the requirements.

During the gap analysis, the relevant sections of the standards reviewed were:

  • CM 10 Marrow Collection Facility Standards - Cellular Therapy Product Transportation and Shipping
  • C10 Apheresis Collection Facility Standards - Cellular Therapy Product Transportation and Shipping
  • D10 Processing Facility Standards - Cellular Therapy Product Transportation and Shipping
Outcome

The gap analysis indicates that World Courier is compliant due to the following:

  • There is a Standard Operating Procedure (SOP) on the handling of Cell/Gene Therapy OPS E003 Cell/Gene Therapy
  • There is evidence that relevant staff have been trained on this SOP and training records are available for review in
    the Training Resource Centre
  • There are qualification reports for the various types of packaging including dry shippers
  • All relevant staff are aware of the requirements of a specific Cell/Gene Therapy project and that, the available
    tools, Cell/Gene Therapy Project Statement of Work and Cell/Gene Therapy Lane Mapping are to be used
  • SOP CORP C001, Performance Qualification of Shipping Container and Lane Risk Assessment used to assess the
    suitability of shipping containers and shipping lanes
  • Notifications sent out when pick-ups and deliveries are completed
  • Work Instruction WI-Ops-E011 Using and Documenting Security Seals is used to ensure security of each shipment.
    This is also covered in SOP OPS E005, Shipment Handling and Cargo Preparation
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About the Authors

A portrait of Simon Eliison.

Simon Ellison

Cell and Gene Therapy Service Director 
World Courier
Simon is the Cell and Gene Therapy Service Director at World Courier.  His role is to develop a portfolio of global logistic and supporting service strategies that take the advanced therapy industry forwards. Whilst at the Cell and Gene Therapy Catapult he identified the need for, and built the Seamless Freight portfolio.  He also helped develop the commercial operating model for the Catapult Manufacturing Centre that resulted in the first collaborators entering, and the start of a cluster forming around this unique facility. Prior to this Simon was the Head of Commercial at NHS Blood and Transplant (NHSBT) where he merged the needs of the industry with NHSBTs manufacturing and supply chain capability. This enabled multiple UK and international organisations to move their therapies forwards.
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Michael Fleischer

Director, Quality-Transport
World Courier
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