Total Risk Score and Categories
| Calculation of the Total Risk Score (TRS) | |||
|---|---|---|---|
| TRS = (RFIV Score) × (RFV Score) × (RFI Score + RFII Score + RFIII Score) | |||
| Possible Range in TRS = 0.05a to 38400b | |||
| Total Risk Categories | |||
| Perceived Risk | Low | Moderate | High |
| Total Risk Score Range | <23 | 23–100 | >100 |
| Testing Level Required | Baseline | General | Full |
↵Notes: a Obtained from the following situation:
RFI = contact at 5 °C for 1 day = 1
RFII = contacting solution is pH 5–8, 0% ethanol = 1
RFIII = <001% by weight total additives, D40 < 10–13 cm2/sec, no significant processing, no special case extractables = 3
RFIV = Presence of an clearance step in the process = 0.1
RFV = Topical/oral powders, oral tablets and capsules (Lowest FDA risk categories), patient exposure < 14 days, daily dose volume < 1 mL = 0.1
TRS = (0.1) × (0.1) × (1 + 1 + 3) = 0.05
↵b Obtained from the following situation:
RFI = contact at 60 °C for 1 day = 1000
RFII = contacting solution is 70% ethanol = 7600
RFIII = >10% by weight total additives, D40 > 10–8 cm2/sec, material exposed to ionizing radiation, special case extractables = 1000
RFIV = Presence of potentially concentrating step in the process = 2
RFV = Inhalation aerosols and solutions, injections (highest FDA risk categories) = 0.1, patient exposure > 12 months, Daily dose volume > 50 mL = 2
TRS = (2) × (2) × (1000 + 7600 + 1000) = 38,400