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.

[@kristamcharan]

Best in class presentation 👍

[@machindrasarak7665]

Nicely Explained sir. Thanks a lot

[@sanjaysananse7654]

Very good presentation 👍🏼

[@tusharpatil9059]

Good Presentation, summarising the changes.

[@tusharrajput1804]

So nice keep it up

[@mohdzohair8702]

Good presentation

[@RameshYadav-or7yv]

Nice presentation

[@pharmaassociates]

Nice explanation

[@sagarpawar-vd5bc]

👍🏻👍🏻

[@nikhilakarte]

Keep it up dear 👍

[@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

[@Seshu03]

Please use flow chart also for better understanding.

[@usatelugu1042]

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

[@Hollywoodbollywood2265]

🇮🇳👏🇮🇳👍good