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

1. Closing Messages
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
Discussion Forum on
ICH-Q9

2. 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

3. Lets grip ICH Q9 & ISO 14971
Harm
Damage to health including the damage
that can occur from loss of product
quality or availability (ICH Q9)

4. Lets grip ICH Q9 & ISO 14971
Hazard Potential source of harm (ICH Q9)

5. Lets grip ICH Q9 & ISO 14971
Hazardous
Situation
Circumstance in which people, property
or environment are exposed to one or
more hazards (ISO 14971)

6. Lets grip ICH Q9 & ISO 14971
Risk
The combination of probability of
occurrence of harm and the severity of
that harm (ISO 14971)

7. Lets grip ICH Q9 & ISO 14971
Residual
Risk
Remaining Risk after risk control
measures have been taken (ISO 14971)

8. Lets grip ICH Q9 & ISO 14971
Severity A measure of the possible consequences
of hazard (ISO 14971)

9. Lets grip ICH Q9 & ISO 14971
Detectability
The ability to discover or determine the
existence, presence or fact of a hazard
(ICH Q9)

10. Quality Risk Management (ICH Q9-2006)
Risk management is a systematic process for the
assessment, control, communication & review of
risk to the quality of the medicinal product across the
product lifecycle

11. Quality Risk Management (ISO 14971-2007)
Risk management is the systematic application of
management policies, procedure and practices to the
task of analyzing, controlling & monitoring risk

12. Risk management is a
systematic process for
the assessment, control,
communication &
review of risk to the
quality of the medicinal
product across the
product lifecycle
Risk management is the
systematic application
of management
policies, procedure and
practices to the task of
analyzing, controlling
& monitoring risk
Q
R
M

13. Regulatory Observations
…. No risk assessment
procedure to evaluate risk to
the products manufactured
in the plant (e.g. toxicity,
design of facility….), the
equipment used, the
qualification/validation
needs ….
French Authority
March 2008

14. Regulatory Observations
…. However, none of the
tests were performed in
accordance with current
recommendations including
a risk assessment ….
WHO
South Africa

15. Regulatory Observations
…. Failed to perform root
cause investigation: risk
assessment to determine the
impact, severity and safety
concern resulting from the
verified root cause of
product failure identified….
US-FDA

16. Regulatory Observations
…. Failed to review all
aspects of the risk
assessment process to
determine if other
components were lacking,
review other risk
assessment for
shortcomings ….
US-FDA

17. System Risk
(Facility &
People)
• Interface ,
Operators Risk,
environmental
components
(equipment), IT,
Design elements
System Risk
(Organization)
• Quality system,
controls,
measurements,
documentation,
regulatory
compliance
Process Risk
• Process
operations &
quality
parameters
Product Risk
(Safety &
Efficacy)
• Quality
attributes:
measured data
according to
specifications
Sources of Quality Risk

18. Q
R
M
T
O
O
L
S
Flow chart, Check Sheets, Process Mapping, Cause &
Effect diagram (e.g. fish bone)
FMEA, FMECA, FTA, HACCP, HAZOP, PHA, etc.

19. Closing Message
The question
isn’t whether we
will have
standards … The question is
how useful can
we make
standards

20. Thank you
Have a very good time