How to Handle Excursions of Stability Chambers?

[@rajasekharreddy8610]

Your explanation is very good and Thank you sir

[@jackmatthews9390]

Well done. very helpful

[@Hari-z1q1y]

Thank you sir

[@sathishkumarchem1]

Very useful information. Thanks for your initiation like this content videos. Thanks once again.....

[@sunitashrestha7762]

Thank you very much, very informative.

[@pavanraju1921]

Thanku sir well explained

[@rkpv5364]

Nice Video. The update is the ICH has a guidance note similar to WHO.

[@raghuvaran7883]

Sprb

[@abhipatil6321]

Sir explaination is too good

[@nookalasaikrishna]

Some auditors asking for impact assessment below 24 hrs also. How to respond pl suggest.

[@tusharbarot5705]

Hi, Mr. Bhaskar How can we increase self-life for our commercial product for NDA Drug Product? If I have 24-month stability on my product and if I want to increase 36-month stability, is there any guidance for that ? and I have some clinical batches for 48-month data which is pass. there is no problem with 48 months. in this case can I apply for 36-month stability increase to US-FDA?

[@honeyjarial619]

Very valuable. And first time know that ICH never says the limit for excursion should not be more than 24 Hours, its WHO who says all about this.. 😀 Please elaborate the risk assessment and impact assessment 🙏🏻.. ( which clears to check the product nature i e., Thermal labile or not) Please explain with market product 🙏🏻 And thank you very much for giving such a valuable knowledge. ☺️