Quality Assurance Program

The ISO-based Quality Assurance Program at Molecular and Cellular Therapeutics ensures compliance with regulatory requirements and external standards set by the FDA and the GMPs and GTPs, as stated in the Code of Federal Regulations and the FD and C Act. The program is staffed by experienced quality assurance specialists who have completed formal cGMP training and who oversee the quality systems (document control and quality assurance, materials management, facilities management, environmental monitoring) used within the facility. We assure that customer requirements are met by integrating a Quality System, which meets regulatory requirements and enables rapid development for therapeutic products.  Our quality system provides a platform that creates meaningful synergy with other functions and groups to ensure continual improvement in processes, products, and people.

The Quality Assurance Program uses a controlled documentation system for cell collection, processing, and transplantation, securing not only compliance, but also the consistent and predictable composition of cellular products, free of unwanted materials.

A two-tiered structure is employed for the quality system documentation. Tier One is the quality manual. Tier Two consists of the detailed information included in protocols, records, SOPs, and forms necessary for the documentation of cell collection, processing, and transplantation. This documentation structure ensures that all procedures follow established guidelines, and that all aspects of cell collection, processing, and transplantation at the University of Minnesota and University of Minnesota Medical Center, Fairview are in compliance with Foundation for the Accreditation of Cellular Therapies (FACT) standards and FDA regulations, as applicable.

Compliance with the requirements of this quality system is established through internal and external assessment of Molecular and Cellular Therapeutics programs.