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 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?

[@jaswinderkaur903]

Need more video like this...

[@justmusicanddance1943]

Perfect explanation 👍👌

[@rajlaxmikar3680]

Very good. subscribed.

[@khanhnam83]

thanks a lot for your work!

[@brijbhankushwaha6286]

Nice and clear information

[@harishasnayak5249]

You are doing good job

[@pharmalearners3120]

Thanks for your appreciation.

[@pianomaster4537]

Please explain about bracketing n Matrix ing criteria

[@elvasiahaan7808]

anyone can help me. I just want to know, is there any guideline like ICH or FDA to be applied in health supplement and traditional medecine product? Or we only need to use this guideline (ICH, FD, etc)?

[@srinivasaraovaragani479]

Shelf life calculation procedures with multi factors using minitab will be useful.

[@maraganidevisarojini1081]

Nice

[@bhushanchaudhari2465]

Please prepare presentation for microbiology test requirements in stability in various stages

[@ranjithkatta992]

If we are supposed to submit stability data of 6 months for a drug product, what we should mention shelf life of that drug substance.. Thanks in advance

[@manojnegi256]

Based on innovator self life you can give expiry date of your product but you need submitt all time point data

[@vikrambehera2010]

At the last moment Unnecessary musics cause harmful to ears. Otherwise remaining are ok.