Accreditation Statistics

As of May 2, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10

 

Initial Accreditations

  • Abu Dhabi Stem Cell Center, Abu Dhabi, United Arab Emirates | Cellular Therapy Product Processing with Minimal Manipulation
  • CHN - Complexo Hospitalar de Niterói, Rio de Janeiro, Brazil | Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and  Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

     

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

Be the Match/National Marrow Donor Program (NMDP) Offers Validation Protocol to Apheresis Collection Facilities Implementing ISBT 128 Label for Collection for Further Manufacture

Posted in :: 2022 Volume 5 :: Friday, November 18th, 2022

Don’t let the new ISBT 128 apheresis collection split label leave you with a split-ting headache! ICCBBA has recently released the ISBT 128 Standard Labeling of Collection Products for Further Manufacture (ST-018) for use on apheresis collection products. To facilitate implementation, Be the Match (NMDP) has developed a validation protocol for collection centers that plan to utilize the new labels. This will allow users to more readily implement ST-018, which provides standardized, consistent labeling to all apheresis collection bags destined for further manufacturing by a sponsor/manufacturer. Please reach out to Tamara Lengacher at NMDP (tlengach@NMDP.org) for questions and/or to request the protocol. Questions about the ST-018 standard should be sent to ICCBBA’s help desk at support@istb128.org.


The Interdependency of Qualification and Validation

Posted in :: 2022 Volume 4 :: Wednesday, October 26th, 2022

Eunice Kim, CLS
Stem Cell Laboratory Manager

Heather Steinmetz, MPH
Quality Assurance Manager

Hematologic Malignancies/Stem Cell Transplantation & Cellular Therapy Program
UCLA Health

Qualification and validation may be erroneously used interchangeably. Understanding the difference and when to use a qualification or validation will support a robust quality management plan. There is an interdependency between qualifications and validations. Validations are built on the conclusions of qualifications.

When baking a cake, high quality ingredients and a tested recipe combine to make a delicious cake. If inferior ingredients or an inaccurate recipe are used, the cake will not bake or taste as expected.

Similarly, validations, like a recipe, are comprised of qualified elements to produce consistent results. Validation is the “confirmation by examination and provision of objective evidence that particular requirements can consistently be fulfilled. A process is validated by establishing, by objective evidence, that the process consistently produces a cellular therapy product meeting its predetermined specifications” (FACT 8th ed).

Qualification is “the establishment of confidence that equipment, supplies, and reagents function consistently within established limits” (FACT 8th ed). Qualifications may be performed by one or more people. Equipment may have installation and operational qualification performed by the vendor, and the laboratory may complete performance qualification.

New validations and re-validations should include a review of material qualifications prior to implementation. If a validation is amended, materials should be evaluated to ensure they are still used according to the qualified function.  In the event of an occurrence, qualified materials and validated processes should both be investigated to determine if materials were used according to the qualified method and the validated process upheld.

Similar to checking ingredients as they are received in the kitchen, it is critical to qualify each supply, reagent and equipment element individually. Validations may then use these qualified elements to test the process for consistency of expected results.

Supplies, reagents, and equipment may be used for multiple procedures; therefore, it is important to understand downstream effects and assess the impact changes may have on multiple validated processes. Verification should be performed when changes to qualified supplies, reagents, or equipment are made. In some cases where significant changes are made, revalidation may be appropriate.

For example, transfer bags may be used in multiple processing procedures. The transfer bag is qualified to consistently function within established limits. The transfer bag may then be used in a validation for each processing procedure.

Use of qualified materials and validated processes consistently produces a cellular therapy product meeting predetermined specifications.  A validated process contains qualified materials. Understanding the interdependency between qualifications and validations minimizes risk to cellular therapy products.

For more information on performing a validation, see FACT QM Series, Module 10, Validation Roundtable, a Program Perspective.


FACT Announces New Quality Management Series, Module 10: Validations

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

The Quality Management Series Module 10 includes four sessions focused on Validation including:

Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Register now

Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

Software Validation
Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation
TBA

Register for the entire module to receive a 15% discount! QM Series Module 10: Validations