The clinical quality management system of advanced therapy medicinal products in the hospital setting: A scoping review.

Abstract

Advanced therapy medicinal products (ATMPs) require rigorous quality management to mitigate risks associated with their development and use in hospitals. This study aimed to identify guidelines, standards of practice, and practical experiences in ATMPs quality management in hospital settings. An integrative scoping review under PRISMA guidelines retrieved 14 studies from four databases, 144 quality management guidelines and standards, and risk management reports for approved ATMPs from three government agencies and six organizations. Thirteen models or programs of quality management practices for ATMPs were identified across 25 hospital-based settings in six countries. Major aspects of ATMPs included clinical quality and translation, logistics management, hospital preparation, and patient care. Primary goals of ATMPs management within hospitals involved regulatory compliance and accreditation with national and regional requirements and implementing and maintaining the standardized operational practices. Four priority actions to enhance the quality of ATMPs management were as follows: (1) risk-based procedures and strategies; (2) strengthening of the skills and knowledge of healthcare professionals and technical staff; (3) validation and maintenance of qualified storage, manufacturing, and delivery facilities; and (4) support for a documentation system. In summary, understanding key components of ATMPs management offers valuable insights for developing an adaptive quality management ecosystem supporting clinical translation.