Eunice Kim, CLS
Stem Cell Laboratory Manager
Heather Steinmetz, MPH
Quality Assurance Manager
Hematologic Malignancies/Stem Cell Transplantation & Cellular Therapy Program
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.