Retesting || 95 % Confidence interval limit || As per MHRA OOS guideline ||

Retesting & 95 % CI as per MHRA OOS Guideline.
Chapters in this video
00:00 Introduction
00:42 Retesting key points
01:52 What is 95% Confidence interval limit?
03:42 Assay test 95% CI
06:02 RS test 95 % CI
08:08 What if 95% CI not meeting criteria?

[@bubundatta4911]

Please make more such kind of vedios

[@saadmanzar876]

Good

[@Rajesh-uh3gl]

Very useful information... Thank you very much and Keep posting.

[@PharmaPill]

Thank you, I will

[@ramakrishnaguttula7941]

Thanks for your valuable information , keep it up sir...

[@PharmaPill]

Welcome Ramki Anna..🤝

[@manojmodi414]

Thank you very much Sir,
Sir retesting situation please cover

[@PharmaPill]

It’s covered

[@kiranyekula6302]

Thank you soo much for sharing your valuable knowledge

[@PharmaPill]

Glad it was helpful!

[@amithnagarajapa9076]

Good Explanations

[@RamPrasad-tm9nl]

Very useful and simply understanding. Thank you sir 👏👏

[@PharmaPill]

You are welcome

[@kidsspeciallr9551]

Thank you. your video all are good..

[@PharmaPill]

You are most welcome

[@rajkumarpandey6377]

In your PPT there is no clarity about calculation of SD. Whether it will calculated on five results of five no. i. e. no. of preparations.
Your SD value is not exactly matching with your data.

[@surendrababuchallagundla9249]

How will calculate the t95% please explain

[@bubundatta4911]

Very very useful vedio

[@PharmaPill]

Thanks a lot

[@prafullwaghmare6589]

Sir pls make Video on Dissolution Study 🙏

[@munindharmunindhar8880]

Thank you sir.T95% table values are constan

[@PharmaPill]

Yes, correct

[@avudoddishankar868]

How to calculate t95 sir

[@sagarnikam4989]

TRY TO CHECK CALCULATION FOR PRACTICE, SD AND SQRT NOT MATCHES PLS SUGGEST

[@srinivasulubhavanasi2734]

Thank you for very valuable information. Can you suggest how way forward will be decided by QA if 95% confidence limit is not achievable, pls extend your support in this regard for more learning pls

[@PharmaPill]

Suppose if it is assay test and 95% CI not meeting , in that case Quality team need to assess min, max & average results of
👉🏻UOD test,
👉🏻Dissolution test,
👉🏻Previous trend of Assay results .
👉🏻Blend stage results of assays and BU test for the impacted batch.
One thing you have to keep in mind if 95% CI is not meeting the criteria it doest mean that your product is failing, It simply indicates that there is a variability in results however results are well within the specification limit. Same results can be considered for reporting.
And further you can monitor upcoming batches assay as well .

[@srinivasulubhavanasi2734]

@@PharmaPill thank you sir for detailed response

[@ravindrapandit2993]

Thanks Nice information , RS Calculation found wrong due to √n Value and plz explain if any result found out of Calulated 95%CL what is further procesd

[@PharmaPill]

Firstly welcome sir and congrats for having eagle eye. Typo error for square root n it should be 1.732 instead of 1.372, but calculation done using 1.732 only..👍

[@PharmaPill]

And answer to second question is.. if 95% failing for any unit then we need to assess trend data. Based on that decision can be taken on batch disposition. If you have any other information,please share all will be benefited.

[@saadmanzar876]

In our company we perform retesting 1st analyst one time second analyst 2 time and third analyst 3 time .. can you refer any guidelines related to this ...

[@PharmaPill]

there is no guideline….company to company practice vary

[@kiranyekula6302]

We got 3 or 5 preparation results, 95 % confidence limit is met.finally what is the final result of the oos batch after getting 3 or 5 preparation results

[@PharmaPill]

average need to report

[@kiranyekula6302]

Finally we can fix the average of re test result?

[@PharmaPill]

could you please elaborate your question ?

[@surendrababuchallagundla9249]

Good but r95 anedi ela calculate cheyyali

[@PharmaPill]

See video carefully

[@venkatalaxmi6778]

How the t95 result will be calculated

[@PharmaPill]

don’t mind I also don’t know… how t95 is calculated. It’s constant value you can check it’s value in guideline as well