Thursday, March 26, 2009

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)

1 comment:

  1. Hi.

    I read a same topic 2 month ago. The topic helps me to improve my competency.

    Apart from that, below article also is the same meaning

    ISO 13485 checklist

    Tks again and nice keep posting
    Rgs

    ReplyDelete