Shelf life extrapolation based on stability studies data

We have 6 Months Accelerated & 36 Months Long-term Stability Study Data for drug substance without any significant changes/degradations - 48th and 60th months study is ongoing.

Shall we extrapolate 60th month shelf life for drug substance based on 48th month long-term established data.

if yes or no - any justification in GMP angle - any guideline/rational justification.

1 Like

There should not extrapolation beyond after 36 months as per ich

Dear Srini,

The main purpose for stability testing is to establish a product profile to ensure that the product is within the set chemical, physical, microbial and container closure parameters.

As per the stability guidelines the recommended testing frequencies are as mentioned.

For long term studies, frequency of testing should be sufficient to establish the stability profile of the drug substance. For drug substances with a proposed re-test period of at least 12 months, the frequency of testing at the long term storage condition should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed re-test period.

These frequencies are to ensure that the proposed shelf life is actual/ real and applicable for the product to sustain the determined or to be determined shelf life.

Hope this clarifies your query


1 Like

Thank you so much for your reply and explore your feedback.

Thank you for your feedback.

First You Go to change control because you are deviate the exp date.