23 April & 21 May 2017 Discussion Forum

1. Discussion Forum on ICH Q7 & Q11
Take Home Messages
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
23 April 2017 (Program A)
21 May 2017 (Program B)

2. Simple & Clear
Take Home Messages & Feedback

3. Identify
potential
CQAs
1 Define Mfg
Process
2 Define
Control
Strategy
3

4. Systematic
Evaluation &
Understanding
1 Functional
relationship that
link MA & PP to
CQAs
2 QRM to establish
appropriate
Control Strategy
for Design Space
3

5. Control Strategy
is a planned set of controls derived from current product
& process understanding that assures product performance
and product quality

6. Control Strategy in
Traditional Approach
Set points &
Operating
Range
1 Set tightly to
ensure
consistency
2 More
emphasis on
assessment of
CQA at DS
3

7. Control Strategy in
Enhanced Approach
More
systematic
identification
of source of
variability
1
More
meaning-
ful &
efficient
control
2
Increased
process
under-
standing
3
Flexibility
in operating
range for
processing
parameters
4

8. Don’t expect clarification from Q11 at this time
Regulatory
flexibility
CPP
Number of
Steps in SM
Mfg
description of
CTD
CPV

9. 10 hour Assignment
2Q-001
to
2Q-200
2Q-401
to
2Q-670
2Q-201
to
2Q-400
1 2 3

10. Study any real case
of failure associated
with the API
Compile report and
discuss it with
reference
1
Make a hand written
(black) summary of Q7
in your own words.
Describe or link with
real example or
possible scenario using
different ink (blue)
Highlight what is not
done in our practice
and what
consequences we
may have in terms of
patient safety & drug
quality
2 3

11. You have option to change but
send an email with the subject
“Change of Assignment”
You have one month. It is a
compulsory assignment
Performance will not be shared but
may be discussed with you
individually upon your interest
Non-compliance
will lead to
discredit for next
program