Control Strategy Points to Consider for Cell Therapy Production
| Input Materials | Manufacturing Facilities | Manufacturing Process |
|---|---|---|
| • Cell harvesting, for example, leukapheresis | • Design | • Personnel qualification and training |
| • Raw materials control, including in-process | • Equipment | • Design |
| • Product containers and closures | • Utilities | • Process risk assessment |
| • Vendor approval (key component suppliers, sterilization of components and single-use systems, and services) | • Preventative maintenance—maintaining equipment and premises (planned and unplanned maintenance) to a standard that will not add significant risk of contamination | • Process simulation |
| • For outsourced services, such as sterilization, sufficient evidence should be provided to the contracting organization to ensure that the process is operating correctly | • Cleaning and disinfection | |
| • Monitoring systems—including an assessment of the feasibility of the introduction of scientifically sound, modern methods that optimize the detection of environmental contamination | ||
| • Prevention—trending, investigations, corrective and preventive actions (CAPA), root cause determination, and the need for more robust investigational tools | ||
| • Continuous improvement based on information from the above systems |