Top 5 interview questions on Stability from ICH and FDA guidance.

In this tutorial, I will discuss about Top 5 frequently asked interview questions on Stability studies from ICH and FDA guidances.

Here is the link of previous tutorials,

For exhibit batch size requirements for ANDA
Part-2:
   • Pharmaceutical Interview Questions| P...  

Part-2A:
   • Pharmaceutical Interview Questions| P...  


To learn about significant changes.

   • Pharmaceutical interview questions on...  

Q.1 Is “significant change” appplicable only for accelerated storage condition? Or is it applicable for Long-term study too!?

Q.2 How many A P I lots are required to manufacture three batches, of each strength, of a proposed drug product?


Q.3 what are various storage conditions for stability and its time points?

Q.4 If one out of the three batches is stored under accelerated conditions, shows a significant
change, what should be done?

Q.5 How long do the three pilot scale batches, need to be
stored before destruction which were submitted as a part of an ANDA?