Revised Out of Specification (OOS) Guidance | USFDA Guidance | OOS Guidance May 2022

USFDA has published a revised version of Guidance for Out of specification investigation in May 2022.
The USFDA Guidance provides details regarding steps for investigation the OOS including the Phase-I Laboratory Investigation, Phase-II Full Scale Investigation, responsibility of analyst, responsibility of supervisor.
The Guidance also provides details regarding retesting, resampling and averaging of test results with their appropriate and inappropriate use.

[@machindrasarak7665]

Nicely Explained sir. Thanks a lot

[@proftalks1680]

Thank you very much..

[@AjayKumar-fn9xi]

😊​@@proftalks1680

[@AjayKumar-fn9xi]

​@@proftalks1680😊😊😊😊

[@kristamcharan]

Best in class presentation 👍

[@proftalks1680]

Thank you for supporting

[@tusharpatil9059]

Good Presentation, summarising the changes.
Waiting for next Presentation

[@proftalks1680]

Thanks for supporting and encouragement sir

[@sanjaysananse7654]

Very good presentation 👍🏼

[@proftalks1680]

Thank you so much..

[@tusharrajput1804]

So nice keep it up

[@proftalks1680]

Thank you for supporting

[@mohdzohair8702]

Good presentation

[@proftalks1680]

Thank you

[@pharmaassociates]

Nice explanation

[@proftalks1680]

Thank you

[@usatelugu1042]

Overall presentation good, but needs little more narration except read out.

[@proftalks1680]

Thanks will surely consider the comment..

[@md.imrankhan8944]

Dear sir good explanation but what is newly incorporated in the revision is not clearly spokes starting of this video, when u add 1st what are changes made in current guideline it will be good video for us

[@proftalks1680]

Thank you very much for your comment. Will surely incorporate

[@Seshu03]

Please use flow chart also for better understanding.

[@proftalks1680]

Thank you very much for your valuable suggestion. Will include the same

[@nikhilakarte]

Keep it up dear 👍

[@proftalks1680]

Thanks for supporting

[@sagarpawar-vd5bc]

👍🏻👍🏻

[@proftalks1680]

Thanks

[@Hollywoodbollywood2265]

🇮🇳👏🇮🇳👍good

[@proftalks1680]

Thank you

[@RameshYadav-or7yv]

Nice presentation

[@proftalks1680]

Thank you🙏