This is a general guideline aimed at providing laboratories with a practical framework for validation and change control which is required under the regulatory framework. This should be applied when introducing new, or changing to or relocation of established, critical process; equipment, facilities or systems in the transfusion laboratory.

The following areas are covered in detail:

  • Change Control - a formal system for managing change;
  • Validation - The documented evidence that the process, equipment, facilities or systems, operating within established parameters, can perform effectively and reproducible giving results meeting predetermined specifications;
  • Qualification - refers specifically to the validation of equipment, facilities and systems.

Please also see appendices to this guideline and note the changes to the previous version in the update below. 

Declaration of Interests

The BSH paid the expenses incurred during the writing of this guidance. None of the authors had conflicts of interest to declare. All authors have made a declaration of interests to the BSH and Task Force Chairs which may be viewed on request.