4. Lets have a look at
Real Cases
From the personal
experience
5. A very famous product
Everybody knows about it
Millions of capsules/week manufactured since
years and years
6. Stability failed
100’s of batches recalled
Factory shut down for years
Several people lost their jobs
Corporate could not sustain
7. Source of gelatin was changed
Assessment was weak
Change impact was not appropriately studied
Stability program was weak
8. 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
9. 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