Top 20 Stability section Interview QUESTION & ANSWERS || Part-1 ||

[@srinivasulubhavanasi2734]

Information is good and way of saying is excellent

[@chanadrababug3562]

Excellent information

[@PharmaPill]

Glad it was helpful!

[@ramakrishnaguttula7941]

Good information sir 👍

[@PharmaPill]

Thanks and welcome

[@pavanraju1921]

Thanku very well explained

[@machindrasarak7665]

Informative

[@PharmaPill]

Thanks hope it was helpful

[@machindrasarak7665]

@@PharmaPill yes very helpful sir.
If possible plz explain bracketing and matrixing guideline in detail.

[@PharmaPill]

Already video is there sir check video list

[@akshaygandharv1971]

Please share 2 nd part and thanks for sharing knowledge sir 🙏

[@PharmaPill]

Okay sure

[@VijayKumar-ez1rx]

Sir.the you are sharing the information is extraordinary. Make few more videos on ich guidelines sir 🤩🤩

[@PharmaPill]

Thanks and sure

[@vkumarpidugu8792]

Thank you so much for valuable information

[@PharmaPill]

Glad it was helpful!

[@vkumarpidugu8792]

@@PharmaPill kindly request you to do one video on stability extrapolation and based on stability data how will propose the shelf life for a drug substance/product 🙏

[@ARONNOK.86]

Excellent sir

[@PharmaPill]

Many many thanks

[@rajuvytlachem]

Good

[@PharmaPill]

Thanks

[@mennamagdy6110]

Thanks sir , can you talk about using sap system

[@balapalem7384]

What is significant changes for Related substances by Hplc

[@rajuahmmed5882]

❤❤❤

[@sudhanjaneyareddyg9860]

We want part-2 vedio sir

[@tej9763]

Please make video on queries in fard

[@varunvara2169]

Is it applicable for vaccine development stability studies???

[@machindrasarak7665]

Hi sir .Suppose we load batch at long term 25 /60 ,ACC 40/75 and intermediate i.e. 30/65 and at 6 month interval ACC condition fails for RS then as per guideline of we analyse 30 /65 i.e. Intermediate condition sample also fails for RS test then how to handle that OOS and what will be it's shelf life

[@PharmaPill]

Thanks for such a deep question.
Answer to your question is: The proposed retest period or shelf life should not exceed the period covered by long-term data.

[@machindrasarak7665]

@@PharmaPill Thanks a lot sir👍

[@maheshpds9]

1. Every commercial batch needs to perform stability studies?
2.If a product fails to meet its specification in the 6th month of accelerated study, what is the shelf life of that product and on what bases we are fixing shelf life?

[@PharmaPill]

1 No, all commercial batches not loaded for Stability. Generally first batch of the Year is loaded for stability.
2. Self life will be based on the long term data in this case when ACC data fails to meet specification. And remember we need to initiate Intermediate condition sample analysis when ACC fails.

[@RD-qx1pu]

Dear sir, How much difference should there be between initial batch and stability batch in assay test i.e trend?

[@venki88k]

Thanks sir

[@PharmaPill]

Welcome

[@WilliamBack-y3t]

Some one kindly tell me what is commitment batch?? Didn't understand slide😢

[@nagasai-qb2he]

bro commitment batch and primary batch are same or not

[@PharmaPill]

Both are different Let me explain you with example:
Primary batches taken before Approval of ANDA
where as Commitment batch taken after Approval of ANDA

[@nagasai-qb2he]

@@PharmaPill ok in that case in normal manufacturing companies has took only commitment batches as validation batches

[@PharmaPill]

not understood your question…

[@nagasai-qb2he]

@@PharmaPill i mean did every validation like process/revalidation batches comes under commitment batches

[@PharmaPill]

No.. Commitment batches are separate batches which are taken after product approval. Generally it involves annually one batch stability loading.

[@pharmadna3939]

Question- 5 ans 😏

[@PharmaPill]

🫣

[@ghanashyambhomkar3822]

Pl