QRM is a systematic process that facilitates communication and transparency between industry and regulators. It helps move organizations from a reactive "fire fighting" approach to a proactive risk management approach. The level of effort for QRM should be based on the level of risk, and always link back to protecting patient safety. QRM considers various tools and methodologies, both qualitative and quantitative, to assess and control risk across a product's lifecycle. The overall goal is a common understanding of quality risk management between industry and regulators.

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
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Process
Facilities
Material Manufacturing
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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