MHRA || OOS Guideline ||

MHRA OOS Guideline
Chapters in this video
00:00 Introduction
00:36 Background
01:10 Phases of Investigation
01:46 Phase-1A Investigation
03:46 Phase-1B Investigation
05:21 Hypothesis testing
06:05 Phase-2 Investigation
08:15 Hypothesis testing
09:38 Phase-3 Investigation

[@maheshpds9]

Excellent bro...... please reveal your DP once.

[@ramakrishnaguttula7941]

Excellent information

[@umadrg4279]

Excellent information explain in brief n beautiful... thank you

[@PharmaPill]

Thanks and welcome

[@syedzohaibahsanmustafashah4661]

I like ur way of describing

[@sreenivasareddykarne5690]

Good information. My doubt why ph. Eur moa used test sample in stanadrd solution for impurities calculation whereas usp moa used standard material for solution preparation and impurities quantification.

[@kiranyekula6302]

Suprb...

[@PharmaPill]

Thank you! Cheers!

[@DeepakSingh-yh5rj]

Thank you.. I always preferred to get the pharma related information only from pharma pill...

[@PharmaPill]

Welcome 🪔 Pahadi 🙂

[@adnanazhar7227]

👍👍👍👍

[@gopeebotcha5296]

❤

[@manojmodi414]

Excellent video

[@PharmaPill]

Thank you very much!

[@solution24x50]

I like all your videos so I am intentionally clicking adds on your videos😆

[@PharmaPill]

hope content is useful 😁

[@SasiKumar-lg1wc]

What is the OOT? how can fix the OOT limit?

[@kiranyekula6302]

When we can do hypothesis analysis with aliquot, mother and fresh sample I.e in which phase

[@PharmaPill]

Hypothesis can be done in phase-1B and Phase-2 through approved protocol.

[@saritasawji5635]

Super

[@PharmaPill]

Thanks

[@maheshpds9]

If OOS is invalid, previously we r repeating 5 or 6 times particular batch sample to confirm there is no product related issues. Now is it required or not required or procedure revised? Any companies following still like this?

[@PharmaPill]

I don’t know about all companies but wherever I have worked there we have followed Multiple preparations during retesting either 3 or 5 preparations . And it’s mandated by MHRA guideline as well that retesting data should have multiple preparations and obtained outcome of retesting shall be evaluated statistically. My next video is coming on retesting only..

[@kiranyekula6302]

If you find root cause in procedure wise in lab investigation, you should revise the specific procedure

[@kiranyekula6302]

At which aliquot, mothet , fresh sample analysis will come as well as triplicate, replicate analysis

[@PharmaPill]

Didn’t understand your question? please rephrase?

[@harishgangulakurthi2445]

Hai sir,i am a big fan of you,this is Harish. I want list total guidelines about API (Deviations,Engineering,watersystem,OOS,HVAC,training,APQR,vendor,change control,CSV) it is very helpful for everyone sir, I hope you will do it sir, thankq.

[@PharmaPill]

Thanks for suggesting a good topic…

[@harishgangulakurthi2445]

Thanq very much sir for your prompt reply.

[@harishgangulakurthi2445]

I am waiting sir.

[@kiranyekula6302]

In which phase we can do resampling

[@PharmaPill]

Re-sampling can be done in any of the phase when sample integrity is in question.

[@manojmodi414]

Sir New OOS guidelines FDA 2022

[@PharmaPill]

yes modi g but little disappointed with new guideline of FDA. Nothing much they have updated. after 14 years they revised guideline just to add few lines and references.

[@DeepakSingh-yh5rj]

In which part Retesting shall be done?

[@PharmaPill]

It can be done in phase-1 as well as in Phase-2 ,whenever assignable cause is identified in either of the phase.

[@DeepakSingh-yh5rj]

If no assignable cause is identified in phase 1 and phase 2..then what is the criteria for retesting?

[@PharmaPill]

@@DeepakSingh-yh5rj in Next part of video I will explain.

[@PharmaPill]

@@DeepakSingh-yh5rj ideally you should not go for retesting without knowing cause.