Quality Control Principles in Apheresis

Therapeutic apheresis (TA) is a highly complex and dynamic treatment method based on the separation of blood components, making the potential for errors significant. Even minor mistakes can jeopardize the health of patients, donors, and healthcare workers. Thus, a robust and continuously evolving quality management system is essential, encompassing factors such as the environment, personnel, equipment, and record-keeping. The American Society for Apheresis (ASFA) guidelines are widely referenced by physicians for medical approaches in TA. However, a standardized approach to treatments is crucial for successful outcomes. To this end, the European Commission and the European Parliament’s Directive (2004/23/EC, 2006/17/EC, 2006/86/EC) outlines the requirements for these applications. Notably, stem cell collection for Advanced Therapy Medicinal Products (ATMPs) and Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration are conducted in apheresis units, with general rules governed by the European Tissues and Cells Directive (2001/83/EC). International standards, developed in line with these directives (e.g., International Standards for Therapeutic Apheresis Units, FACT-JACIE), play a crucial role in defining the standards for apheresis units. This chapter summarizes that key areas that an apheresis unit should address to operate in compliance with these directives and standards.