Out of Specification & Out of Trend Investigations
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- Опубліковано 6 вер 2024
- This training session will help to understand about out of specification results, FDA requirements about OOS investigation, Phase 1 and Phase 2 investigations, some examples of FDA citations, common problems of OOS, Outlier tests, Retesting and Resampling considerations and Practical example of thee sigma and six sigma for Out of trend evaluation
Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device
Great virtual training...Thanks a ton. Providing knowledge to public is a kind of social service...and a task of PUNYA...God bless you.
So nice of you. Please keep learning !!!
Sir It's a very clear and transparent language to understand everything by everyone it's amazing
Thank you. If you have not gone through recorded session on human error investigations, you can search in channel and go through it..
Ok sir
thanks for your great explanation about OOS investigation it will be very useful to attend the interview.
Welcome. I always tell people - Keep Learning !!!
Amazing..thank u sir...keep explaining like same...its realy helpful for us....
Welcome. Please keep learning !!!
Greate session sir
Thanks. Please keep learning !!!
Excellent training session....
Ashish Jain Thank you so much for your kind comment
sir thank you for this really i cant express my feelings in word..today i just said to my sir that u have to wait till monday to make the sop effective of OOS.thanks sir
one day you will not have just 10000 subscriber one u vl have 1000000 subscriber and that too within short span of time...
thanks sir.
Thank you so much for your kind wishes.
@@hitendrakumarshah3718 sir plz tell me about airlock becoz
i have studied that cascade airlocks are for osd
bubble is for parenteral
and sink type is for poisionous substance
but i have always seen cascade type of of airlocks whether in osd pharma or in parenteral
Very good
Thanks
Thank you so much my dearest sir for your support for us
Welcome
One more great session. Thanks
Thank you so much dear
Nice content explain by you sir
Thanks
great learnings sir... thanx
Thank you so much
Great session sir, thank you a lot sir
Welcome !!!
Very very valuable session
Thank you. Keep Learning !!!
True sir g... There should not be intension of releasing batches which can really be questionable . 😊
Absolutely. The intention should not be just to release the batches which are under question.
Thanks sir very good information
Welcome. Keep Learning !!!
Good information sir
Thank you for your kind comment
Statistical tools of OOT you are showing the 3sigma value 6.99.the value will be added to the average result (99.35) gives 106.34. but according to diagram it shows 104..the minus 3sigma and minus 6sigma values also show like this.so i have a doubt ,,.the 3 sigma means the std deviation value multiply or plus with 3..(if plus means the results were match with diagram)
Yes. you are right. There is an error while copy from excel to power point. We need to add and also substract the 3sigma value to average result. Good. Keep it up.
Sir which guidelines follow ,either MHRA or FDA
If OOT result identify in dissolution test,so in which phase we perform further 6 sample test.to chech either product meet s2 critera or not
Please refer FDA guide
What is the limit of Averaging of retest results, is it enough to meet the specification limit or is there any requirement for averaging limit in guidline for retest results.
The average results of course should be within the specification.
Nice session
Thanks for your kind reply
Thank you so much for this video. If there is an OOS in content uniformity for ointment and there is no option for stage 2 and stage 3 testing, how to do the further investigation?
You can investigate through OOT procedure. As, all batches will comply at stage 1 only specific batch will go to stage 2 or 3
Please guide if Hypothesis testing is done in phase I or Phase II.
One company performed hypothesis testing in phase I by retesting to check contamination due to glassware.
Whether retesting is allowed in Phase I?
You can perform retesting on same sample preparation. You should not prepare sample and standard again at Phase I
@@hitendrakumarshah3718 sir hypothesis means aliquoit, mother and fresh sample analysis, but here fresh means reparation of sample, but you said in phase1 fresh preparation is not acceptable then how?
Nice
Thanks for comment
Sir I have one doubt .If the system suitability (Rsd of RT or area ,NTP, Tailng factor) of test fails can we go for oos investigation or not.
If the final test results are out of specification, then whatever is the reason, we need to go for the OOS investigation.
@@hitendrakumarshah3718 sir actually final result is pass but system suitability only fail(theatrical plate) so can I closed this case under variation (column falt or whatever) or should I go to OOS investigation (phases 1 and phase 2)
Gd Session sir. Prepare long video on risk assessment
Sure. Thanks
Sir could you please explain about bracketing aproches for stability and all ich guidelines
Sure. Will take on separate video.
What is meant by outlier results
I will take a separate session on outlier, biological and microbiological investigations.
How to fix the oot limits in RS test
For RS, you can check and put an internal limit for OOT based on available data, type of impurity etc.
Dear sir, I requested you to explain the microbial failure oos investigations. ..for FP / RM...Please do the needful
Have you refered data integrity in microbiology? You can go through the below link.
ua-cam.com/video/76xZaMcsX1Y/v-deo.html
Further, I will have session on practical investigation of microbiological OOS
Sir, in oot if in phase 1 and phase 2 investigation there is no root cause identified and during hypothesis also we are not concluded root cause, what we have to do and how to close oot.
If there is OOT, there must be some variability. We need to evaluate the causes of variabilities. If you not having root cause, you can work out on probable cause.
can you explain the out of trend calculations for stability studies?
You can refer sigma rule for OOT. I suggest you can refer Product Quality Review session for more clarity.
Sir it was nice session. Kindly brief where can we applied the outlier testing which is to be mentioned in SOP.
The outlier testing can be applied where, statistical criteria will be considered. for example, microbiological testing (Assay) etc.
sir g... plz hav leanings on QMS in detais deviation...change control...capa..with case studies.
Sure. I will be taking the session on "Pilars of Quality". during this discussion, will take detailed on deviation, cc. complaint, recall and all other QMS
Sir can i have another session for Stability in detail and how to calculate shelf life of product
Sure
Dear sir.
In the stability department, is there any trend in the physical parameter like friability.
Ya only in assay or impurity.
Please reply as soon as possible
You can trend friability and other physical parameters also in addition to assay and impurity.
Sir but we just get the sample in which we can only go for 1 testing so sir if we will has an OOS then how will we go for retesting.
If sample gets exhausted during one testing you can go for resampling. I think you are microbiologist. In your case, duplicate sample may be withdrawn by QC person. However the quantity equivalent to single analysis. In case of OOS, you can request the quantity from same sample. It will be same aliquote of sample hence you may not need the resampling. Please check with your QC.
Hi sir, for the hypothesis test don't have FP sample. What I will do
You can take an extra sample from operations. As per the guide, if the sample is exhausted, you can go for resampling.
Outlier test having some doubts
What are the doubts?
Sir its very good session..
Sir shall v raise REJECTED NOTE for OOS
Is Rejected note related to OOS
Yes. ofcourse. If OOS is confirmed, you have to raise rejected note.
Sir any need to raise oos oot incident and deviations in R&D
Yes. of course.
What is hypothesis? Brief it in details sir...
Hypothesis means experimentation to support the probable cause. I will prepare detailed video on this.
Sir very good training... But kya aap हिन्दी मे भी बता सकते है??????
OK. I will take it Hindi also.
Are method validation oos also should be investigated if it is due to analyst error?
Yes. The errros should be investigated . Analytical method validation should follow GMP requirements similar to process validation, cleaning validation etc.
@@hitendrakumarshah3718sir is oos also applicable for cleaning samples
hello sir, pls briefly expline 3s and 6s caluculation
Please check the recorded webinar on Product Quality Review. You can access through the link below; ua-cam.com/video/mFC3XNes-pA/v-deo.html
Sir if we got 550 % in dissolution wt is de next procedue it's oos or oot please calrify me
If the results are more than 100% drug while standard label claim is 100% only. WE need to evaluate whether the investigation procedure for OOS and OOT is same? if yes doesnt matter. Here you can raise OOT if investigation procedure is same.
Sir which sigma recommend by FDA and MHRA 3 or 6
The guides expects trending. You can decide which tool is suitable for evaluation of OOT.
@@hitendrakumarshah3718 which sigma is more stringent 3 or 6
sir please provide the training ppt.
you can download the material from below link; we.tl/t-tUOw6Luan7
Sir when you r going to next webinar
My no 9945528171
Hi, I am planning in this week end. As, I was not feeling well since long, I could not arrange. But now regularly I am planning to conduct online FREE learning from coming saturday.
How I come to know
@@amaranathar7947 I have created whatsapp group. I normally share link to join on group. If you are not connected through whatsapp, I suggest to send me whatsapp message to 8689981962. I will add you in the whatsapp group.
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How long could I hold my oos or oot investigation remaining no root cause identified.
As per FDA, 20 business days