Comment from Lupin Limited
AnonymousSupportIndividual
Summary: The commenter suggests that the guidance should include a provision to waive accelerated stability testing based on exhibit batch stability trend data. They argue that for certain products, failures at higher temperatures are inherent to the product's nature rather than a result of the change, making trend data a more reliable indicator for post-commercialization changes.
IN view of SUPAC guidance , based on changes stability requirement is prescribed. Accelerated stability testing is also recommended. I suggest to include a clause in guidance to waive off Accelerated stability testing based on Exhibit batches stability trend data. Certain instances where due to product nature mostly failure in certain test parameters are seen. Failure are due to product nature at higher temperature. Based on trend and product nature for any change in post commercialization waiver in Acc. condition stability can be done.