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

Рет қаралды 36,361

Pharma Pill

Күн бұрын

Пікірлер: 45

@srinivasulubhavanasi2734 Жыл бұрын

Information is good and way of saying is excellent

@pavanraju1921 4 ай бұрын

Thanku very well explained

@ramakrishnaguttula7941 Жыл бұрын

Good information sir 👍

@PharmaPill Жыл бұрын

Thanks and welcome

@chanadrababug3562 Жыл бұрын

Excellent information

@PharmaPill Жыл бұрын

Glad it was helpful!

@sudhanjaneyareddyg9860 Жыл бұрын

We want part-2 vedio sir

@mennamagdy6110 Жыл бұрын

Thanks sir , can you talk about using sap system

@akshaygandharv1971 Жыл бұрын

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

@PharmaPill Жыл бұрын

Okay sure

@VijayKumar-ez1rx Жыл бұрын

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

@PharmaPill Жыл бұрын

Thanks and sure

@vkumarpidugu8792 Жыл бұрын

Thank you so much for valuable information

@PharmaPill Жыл бұрын

Glad it was helpful!

@vkumarpidugu8792 Жыл бұрын

@@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 🙏

@tej9763 Жыл бұрын

Please make video on queries in fard

@rajuahmmed5882 Жыл бұрын

❤❤❤

@ARONNOK.86 8 ай бұрын

Excellent sir

@PharmaPill 8 ай бұрын

Many many thanks

@machindrasarak7665 Жыл бұрын

Informative

@PharmaPill Жыл бұрын

Thanks hope it was helpful

@machindrasarak7665 Жыл бұрын

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

@PharmaPill Жыл бұрын

Already video is there sir check video list

@rajuvytlachem 8 ай бұрын

Good

@PharmaPill 8 ай бұрын

Thanks

@maheshpds9 Жыл бұрын

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 Жыл бұрын

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.

@balapalem7384 Жыл бұрын

What is significant changes for Related substances by Hplc

@venki88k Жыл бұрын

Thanks sir

@PharmaPill Жыл бұрын

Welcome

@varunvara2169 4 ай бұрын

Is it applicable for vaccine development stability studies???

@machindrasarak7665 Жыл бұрын

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 Жыл бұрын

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 Жыл бұрын

@@PharmaPill Thanks a lot sir👍

@RD-qx1pu Жыл бұрын

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

@nagasai-qb2he Жыл бұрын

bro commitment batch and primary batch are same or not

@PharmaPill Жыл бұрын

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 Жыл бұрын

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

@PharmaPill Жыл бұрын

not understood your question…

@nagasai-qb2he Жыл бұрын

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

@PharmaPill Жыл бұрын

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