Accreditation Statistics

As of June 3, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10

 

Initial Accreditations

  • Cord Blood Bank University Hospital Basel Cord Blood Collection (Fixed and Non-Fixed sites), Banking, and Release for Administration of Unrelated and Related Donations
  • Cord Blood Bank Geneva Cord Blood Collection (Fixed, Non-Fixed sites), Banking, and Release for Administration of Unrelated and Related Donations

     

A complete list of accredited organizations can be found at https://accredited.factglobal.org/.

Pilot Assessments Validate the Effectiveness and Efficiency of FACT Audit & Assessment Services

Posted in :: 2024 Volume 3 :: Monday, June 24th, 2024

By Liz Ferraro, FACT Audit & Assessment Services Manager

FACT Audit and Assessment Services (FAAS) is the latest addition to the suite of services offered by FACT Consulting.  Our primary objective is to address the complex issue of multiple manufacturers auditing the same treatment site.  Each assessment we perform combines the options for a standardized checklist of applicable geographic regulations supplemented by custom requirements of a particular client. The final assessment report is provided to the client, and then identifying and proprietary information of the client is removed so that the report can be made available to additional stakeholders such as manufacturers, sponsors, license holders, or registries seeking assessment of the same site.  This process not only alleviates audit burden on the sites but also optimizes resource allocation for the client(s) pursuing site assessment.

To validate the efficacy of our approach, FAAS conducted pilot assessments with three different manufacturers, each seeking qualification of a different cellular therapy collection site.  These assessments were conducted in the presence of the manufacturers, allowing for direct observation of our process and solicitation of feedback regarding its effectiveness and appropriateness.

The overall feedback from both manufacturers and sites was positive.  They expressed satisfaction with various facets of the process, including the thoroughness of preparation, expertise of the FAAS team, value to both the site and the manufacturer, and tangible outcomes derived from each assessment.

Testimonials from site personnel underscored their potential for improvement facilitated by our approach, with comments such as:

  • “We feel this will help us improve.”
  • “This was a very robust audit.”
  • “The audit approach was polite and effective.”

Manufacturers were satisfied with the comprehensive nature of our assessments, commenting:

  • “This is a more robust assessment than what we typically do.”
  • “If you assess the entire operation at a site we are interested in, we will request the report without going on-site.”
  • “We like that you can assess for our specific elements in addition to the standard FDA regulations.”

This feedback underscores the value FAAS brings to the site assessment process. In short, FAAS assessments are effective and efficient, and a more valuable use of sites’ and clients’ resources than the audits currently performed.

We also incorporated feedback to improve our processes, such as facilitating clear and frequent communication among the site, the client, and FAAS. FAAS remains committed to continual improvement, and will continue to seek feedback and refine our processes to ensure we are exceeding expectations of both clients and sites.

For those interested in learning more about how FAAS can address their specific challenges, whether that be manufacturers needing assistance to manage assessment workload or sites seeking to reduce their audit burden, we invite inquiries through the following channels:

  • Contact Liz Ferraro at liz.ferraro@factglobal.org to ask questions or discuss your particular needs.
  • Manufacturers, sponsors, license holders, and registries may also submit a no-cost, no-commitment Needs Assessment Form, available on the FACT Consulting website, to expedite input and proposals from FAAS.

Let’s work together to enhance patient access to essential cell and gene therapies through collaborative partnership and innovative solutions.