Information is good and way of saying is excellent
@pavanraju1921
6 ай бұрын
Thanku very well explained
@chanadrababug3562
Жыл бұрын
Excellent information
@PharmaPill
Жыл бұрын
Glad it was helpful!
@ramakrishnaguttula7941
Жыл бұрын
Good information sir 👍
@PharmaPill
Жыл бұрын
Thanks and welcome
@sudhanjaneyareddyg9860
Жыл бұрын
We want part-2 vedio sir
@ARONNOK.86
10 ай бұрын
Excellent sir
@PharmaPill
10 ай бұрын
Many many thanks
@rajuvytlachem
10 ай бұрын
Good
@PharmaPill
10 ай бұрын
Thanks
@rajuahmmed5882
Жыл бұрын
❤❤❤
@mennamagdy6110
Жыл бұрын
Thanks sir , can you talk about using sap system
@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 🙏
@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
@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
@tej9763
Жыл бұрын
Please make video on queries in fard
@venki88k
Жыл бұрын
Thanks sir
@PharmaPill
Жыл бұрын
Welcome
@varunvara2169
5 ай бұрын
Is it applicable for vaccine development stability studies???
@balapalem7384
Жыл бұрын
What is significant changes for Related substances by Hplc
@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.
@RD-qx1pu
Жыл бұрын
Dear sir, How much difference should there be between initial batch and stability batch in assay test i.e trend?
@user-hj7ys6gj7k
Ай бұрын
Some one kindly tell me what is commitment batch?? Didn't understand slide😢
@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👍
@ghanashyambhomkar3822
Жыл бұрын
Pl
@pharmadna3939
Жыл бұрын
Question- 5 ans 😏
@PharmaPill
Жыл бұрын
🫣
@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.
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