Risk Management for Bio-Pharma ICH Q8 and ICH Q9

ICH Q9 elements of risk management

Risk Identification -> Risk Assessment ->Risk Mitigation -> Risk Communication

How to identify risk

•Theoretical analysis
-Science, engineering, or math
•Based on experiments
-Structured or unstructured experiments
-Edge of failure or validation
•Statistically derived
-Trend analysis

FMEA and HACCP

FMEA salient features

•How can the process fail?
-Power outage stops mixing
-Wrong valve open sends product to drain
•How can each mode be made less likely to occur, and less harmful if it does occur?
-Back-up power, UPS
-Feedback or automation control

ICH Q8 design space

Risk AssessMent

Risk can be reduced by

•Risk mitigation—two strategies
•Reduce the severity (building codes for earthquake resistance; testing)
•Reduce the probability (stop sign at intersection of two roads; training)