Our quality team is responsible for executing suitable methods to characterize our Phase 1/2 cell therapy and biologics products and for managing the quality management system, or QMS.
We define “product quality” as “fit for intended use,” meaning the product is consistently manufactured to possess certain attributes, such as strength and purity, thus ensuring safety and effectiveness. We believe that every team member within the value stream of the product owns the quality of our products as the on-time delivery of fit-for-use product to our patients.
Quality is nonnegotiable in our industry. High-quality products significantly reduce potential variability in clinical outcomes. Improved quality positively impacts productivity by reducing re-work, delays in product manufacturing, and deviations and corrective and preventive actions, or CAPA. The quality of our products and services builds trust with our partners and with health authorities, and it affects patients’ decisions about where they wish to receive treatment.
The QMS is the tactical process that enables us to assess a product’s fit-for-use characteristics, identify operational and compliance risks and carry out continual improvement. These processes, illustrated here, are designed to ensure the manufacture of consistently high-quality product, but our organizational culture of quality is also critical.
View/download the full QMS flowchart.
We believe that the foundation of continually manufacturing high-quality product is based on a culture of quality within our entire core. We aspire to sustain an organizational culture in which we all have shared beliefs, values, attitudes and behaviors of owning product quality.
Foundation for the Accreditation of Cell Therapy (FACT) application for inspection submitted March 30, 2021.