A Model Overall Risk Assessment for Elements of a Drug Substance Process Train
| Potential Sources of Risk Element | O | D/C | S | RPN | Overall RA (RPN): Sum of Each Individual RPN Score 200 to 1800 |
|---|---|---|---|---|---|
| Raw materials (control, source and origin) | 2,4,6 | 2,4,6 | 10 | 40, 80, 120, 160, 240, 360 | |
| Upstream expression/production system | 2,4,6 | 2,4,6 | 10 | 40, 80, 120, 160, 240, 360 | |
| Upstream production process | 2,4,6 | 2,4,6 | 10 | 40, 80, 120, 160, 240, 360 | |
| Downstream purification process including virus filter | 2,4,6 | 2,4,6 | 10 | 40, 80, 120, 160, 240, 360 | |
| Q5a-compliance of the manufacturing process | 2,4,6 | 2,4,6 | 10 | 40, 80, 120, 160, 240, 360 |