Grouping & Discussion

Obaid AliCivil Service Officer, Member, ISPE, PDA

26 March 2017

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

Phenomenon 1

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

Is it correct to

determine

the expiration

dates?

Yes/ No

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

Remember

to reportEvery stability failure to Regulatory Authority

within timeframe

No matter if test is conducted after the expiry

of final stability time point

Phenomenon 2

Representative

Can a filled vial be used as representative sample of drum

if both are shipped together in same environment?

No