Discussion Forum on ICH-Q9 at ICCBS, University of Karachi on 23 July 2017

1. Q-9 Modern Approaches and Tools in
Pharmaceutical Manufacturing
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
Discussion Forum on
ICH-Q9

2. Connect the dots and link back to the patient
D
E
S
I
G
N
Process
Facilities
Material Manufacturing
D
I
S
T
R
I
B
U
T
I
O
N

3. Great Idea to Practice
Industry and
Regulators need
to know
Which risks first
Which tools are best
Which is good
approach
Which is bad
approach

4. Lets use Tool & Rely on mixed kind of Information
Expert
judgment
QualitativeQuantitative

5. Lets use Tool & Focus on Systematic Thinking
Define the risk
question
Organize
information under
categories,
attributes
Build decision
making path

6. Why Q-9
?
To ensure a common
understanding of
Quality Risk Management
by both industry &
Regulators

7. Why Q-9
?
Facilitate moving to the Desired State
Facilitate Communication & Transparency
From Fire Fighting to Risk Management

8. Q-9
explains
Common Language & Process
Potential Methodologies for QRM
Where QRM add value

9. QRM does not discuss
a single tool but the
approach
(right tool for the job)
Ideas & Concepts
Quantitative & Qualitative
Real numbers & Real Time
RM
Tools

10. The evaluation of the risk to
quality should be based upon
scientific knowledge &
ultimately link back to the
protection of patient
1

11. The level of effort, formality
and documentation of QRM
process should be
commensurate with the level
of risk
2

12. QRM is a systematic process
for assessment, control,
communication and review
of risk to the quality of drug
product across the product
lifecycle
1 2

13. Appropriate use of
Quality Risk
Management (QRM)
can facilitate
QRM does not
remove industry’s
obligation to comply
with regulatory
requirements
but
Always
Remember
Never
Forget
and

14. Thank you
Have a very good time