Post on 11-Apr-2017
Not the view of DRAP
Current judgment
No obligation on DRAP
Regulatory experience
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References US-FDA WHO ICH NRAs
A very famous product
Everybody knows about it
Millions of capsules/week manufactured since
years and years
Stability failed
100’s of batches recalled
Factory shut down for years
Several people lost their jobs
Corporate could not sustain
Source of gelatin was changed
Assessment was weak
Change impact was not appropriately studied
Stability program was weak
Inspector asked to perform disintegration
test of capsule manufactured a year before
A month old batch found not qualified for
disintegration test
Failed
Failed
Failed Failed Failed
Characterization of Gelatin is very difficult
Because it is from natural source
Storage, Transportation and its Handling require narrow
control range for humidity & temperature
A lot of variation potential
Tube
Uniformity
failed
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B
Important
characteristic
failed
Fluocinonide Cream 0.05% (36 month shelf life)1
Shelf life
determination is
not correct
Commitment on 3 month data
Can a generic product filed with 3 month data and
committed to provide 6 month data in future be accepted?
Decommissioning of Commissioning
How long do pilot scale batches need to be stored before
they can be destroyed?
Math with other Science
Can mix and match approach be applied, for e.g. one
batch at 6 month and 2 batches at 3 month