Factor IV Analysis, Process Factors (RFIV Score)
| If there are no dilutive,a concentrative,b or clearancec steps between contact and final product generation … | Then the value of the RFIV score is 1 |
| If there are one or more dilutivea steps between contact and final product generation … | Then the value of the RFIV score is 0.5 |
| If there one or more potentially concentrativeb steps between contact and final product generation … | Then the value of the RFIV score is 2 |
| If there are or more confirmed clearancec steps between contact and final product generation … | Then the value of the RFIV score is 0.1 |
↵Notes: a A dilutive step is a processing step where the solution that contacted the manufacturing component is significantly diluted prior to the last process step (which produces the final drug product).
↵b A concentrative step is a processing step where the solution that contacted the manufacturing component is significantly concentrated prior to the last process step (which produces the final drug product).
↵c A clearance step is a processing step that has been confirmed to remove extractables from the process stream.