This document summarizes a presentation on ICH Q9 Quality Risk Management given by Dr. Obaid Ali. The presentation introduces ICH Q9, discusses key concepts like availability risk, risk assessment matrices, and the risk management process of identifying, assessing, managing and mitigating risks. It provides examples of how these concepts apply to risks like traffic accidents. The presentation emphasizes understanding the boundaries and appropriate use of quality risk management, and that its application may be limited to product quality rather than molecule safety and efficacy.

1. Discussion Forum on
ICH Q9
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
ICCBS
University of Karachi
23 July 2017

2. D
I
S
C
L
A
I
M
E
R
Personal Point
of View
No
Obligation
on DRAP
Knowledge &
Experience
Current
Judgment
This presentation discusses science, nothing
more and nothing less

3. Introduction & Update on
ICH-Q9

4. H. Gregg Claycamp, Office of New Animal Drug Evaluation, CDER, FDA
Frederick Razzaghi, Office of Pharmaceutical Sciences, CDER, FDA
Michael Kerr, Parenteral Drug Association
ICH Q9 & ISO 14971 - Guidance Documents
References

5. Patients First

6. Availability Risk
Balancing potential quality risk with the
risk of a patient not getting the drug

7. Availability Risk
Balancing potential quality risk with the
risk of a patient not getting the drug
Predict quality problems before they happen

8. Direct, open and
honest
communication
Collaborative
relationships are the
need of hour
Why
?

9. RISK

10. RISK
S
E
V
E
R
I
T
Y

11. RISK
P
R
O
B
A
B
I
L
I
T
Y

12. RISK
D
E
T
E
C
T
A
B
I
L
I
T
Y

13. Detectable and controlled lion Less detectable & free small snack
Which is Dangerous

14. Fall less frequently (1 time in a month) Fall more frequently (10 times in a month)
Which is Dangerous

15. Combination of the probability of occurrence
of harm and the severity of that harm

16. The
investigation of
risks
is at once a
scientific activity
and an
expression of
culture
Managing Risk
is a Behavior

17. Parameters for “calculating” Risk
• PastProbability
• TodayDetectability
• FutureSeverity
T
I
M
E
Risk Priority Number

18. Risk Calculator

19. Risk Assessment Matrix
Severity
Probability
Frequent Likely Occasional Not often Unlikely
Catastrophic E E H H M
Critical E H H M L
Marginal H M M L L
Negligible M L L L L

20. T
O
T
A
L
S D P

21. T
O
T
A
L
S D P
Identify Assess Manage Mitigate

22. T
O
T
A
L
S D P
Identify Assess Manage Mitigate

23. T
O
T
A
L
S D P
Identify Assess Manage Mitigate

24. T
O
T
A
L
S D P
Identify Assess Manage Mitigate

25. Lets see how it works
Road Traffic Pedestrian

26. Lets see how it works
Without
Stop Board
With
Stop Board

27. Lets see how it works Stop Sign
Light
Pedestrian
sign
Back
Counting
Severity

28. Lets see how it works Stop Sign
Light
Pedestrian
sign
Back
Counting
Probability

29. Lets see how it works Stop Sign
Light
Pedestrian
sign
Back
Counting
Detectability

30. Quality Risk Management (QRM)
understand the application boundaries & flexibility
Use it
but
don’t misuse

31. Quality Risk Management (QRM)
understand the application boundaries & flexibility
Does it apply on
Molecule Safety
& Efficacy
Does it is
limited to
Product Quality

32. Thank you
Have a very good time