Frequently asked Interview Questions on OOS

#interview #oos #pharma #qc
Frequently asked Interview Questions on OOS
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[@anoopsingh714]

Thank you for wonderful explaination, plz also incorporate current guideline detail in ppt also for better clarity

[@bheema2196]

Hello sir, Indeed phenomenal examples selected in presentation.. I have been watching your videos which no other channels or platforms could provide this pragmatic approach with real time examples. Thank your for enriching the knowledge for the aspirants.
With related to above video, i would categorically disagree with the OOS requirement when bracketing standard failure. In your explanation, you have motioned that OOS deemed not necessary when sequence end with bracketing standard. Nonetheless, According to the current industry practice and due consideration of risk on the sample, It must handled through logging OOS and OOS investigation can be closed in Phase I with obvious error. Other hidden reason, we could not assure the bracketing standard failure is solely instrument malfunction rather it could be deliberate action to generate bracketing standard failure result.
Thank you..

[@shankarkhot6385]

Very good Explanation and very informative,

[@bulusuni]

Excellent

[@galeebusheik5816]

Well explained sir..tq

[@sarasvtikharat9905]

Ur each and every topic is important to me and thanks for given useful knowledge for me

[@mukhaddarchilakala491]

Sir... Superb sir... Thank you sir

[@pharmaassociates]

Nice sir

[@sameer_shindeshinde3674]

For hypothesis testing
That is performed as per stp is not required to take saprate oos,
Because we can include it in same oos that already taken for that hypothesis is going on

[@balapalem7384]

Hi Sir,
Do you need file a FAR for oos observed in the ACC condition where the long-term found to meet the specifications

[@sapnasontakke5130]

Ur third point not cleared although I have taken oos inspite of my bkt rsd failured observed

[@suryapratapsingh4990]

I think sir 3rd point not right.... we raise OOS if any out of results found

[@DeepakSingh-yh5rj]

Thank you sir for the valuable information. But I'm not satisfied for question no. 3. If any results generated and found OOS, then it should investigate through the procedure of OOS.

[@deepakangude6980]

Q3 related to only system sutaibility failure not result failure

[@sarasvtikharat9905]

Third point is correct , because if ur system suitability is not in this condition u no need to take oos , u have invistigate through incident , and find out the proper toot cause of system suitability failure, lot of reson to failure like . Column efficiency, any type bubble in ur port or likage , and more

[@DeepakSingh-yh5rj]

@@sarasvtikharat9905 multiple samples were analysed in same sample set sequence and Oos result observed only in 1 sample, if results are generated then it should be investigated through OOS.

[@sarasvtikharat9905]

Sir ur third point is not given proper clear arity , because as per my knowledge in ur running sequence any type batch are failed , before taking incident u must need to report ur value and find out any type of oos or oot in this batch , if results is in oos in that case u have need to raise oos and find out the proper toot cause