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 Intervi...
Part-2A:
• Pharmaceutical Intervi...
To learn about significant changes.
• Pharmaceutical intervi...
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?
4 июл 2018
