General Debate

1. Grouping & Discussion
Obaid Ali
Civil Service Officer, Member, ISPE, PDA
26 March 2017

2. Not the
view of
DRAP
Current
judgment
No
obligation
on DRAP
Regulatory
experience
D
I
S
C
L
A
I
M
E
R
References US-FDA WHO ICH NRAs

3. Phenomenon 1

4. Shelf life was reduced to 15
months from 18 months
Adjustment was due to results
of three validation batches
Is it correct to determine
the expiration dates? ?
Projected
Failed in 11
lots
Rationale

5. Is it correct to
determine
the expiration
dates?
Yes/ No

6. NO
Because
It is not a minor, but a significant issue (11 lots)
Trust is lost about strength, quality & purity at the
time of use
Root cause & rationale of decision is missing

7. Remember
to report
Every stability failure to Regulatory Authority
within timeframe
No matter if test is conducted after the expiry
of final stability time point

8. Phenomenon 2

9. Representative
Can a filled vial be used as representative sample of drum
if both are shipped together in same environment?

10. No