Deviation in Pharmaceutical industry, deviation management, what is deviation.
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- Опубликовано: 23 авг 2024
- This video will tell you Deviation handling in Pharmaceutical industry, Deviation management in pharma industry and will let us know that what is Deviation.
Helpful
Badhiya
Very informative video.
Love & respect from Bangladesh
Mr. Tareq. thanks for watching and appriciating my video, specifically when when you said love from Bangladesh it touched my heart. Thanks a lot.
Sir please make a detailed vedio on calibration of weight balance ⚖️⚖️⚖️
Very helpful video sir, I'm working IPQA department in pharma company.
All the best
Bahut badhiya
Nice👍
Thanks ✌
Nice information
Dear sir, excellent job but voice in little room resound. Thank you so much you providing best information
Excellent 👏 please make more videos...... We have no of topics, I want to learn in your easy way
Will upload soon
thank you so much sir
to give such good information 🤗🤗🤗🤗👏👏👏👏👏👏
Thanks Dear
Ooooooooooooo99
Thanx sir
Hi sir ,
In Analytical R&D-
Is analytical development formulation department is better for career growth in pharma.
Good information for everyone..... Now my one sugesion Pls provide Reason for broken/damade tablets in BQS & CAM nMX machine
Thanks dear to like d video, sure I will make d video as demand
Superb sirji thank you
Good lecture
Nice
Thanks
Thank u sir .most valuable information shared to us . Could Pls explain about change control , incident ..
sure
Thank you sir, nice video
Good information sir.
Thanks and welcome
Very good🌹🌹🌹🌹🌹🌹🌹🌹🌹🌹 good information
Thanks dear
Thank you for this video 🎉🎉
Ur welcome
Good Information. I have a question: should I include an Impact Assessment section in my Deviation template?
ya sure y not, even it would be better to estabilish your deviation
Bring more video's sir
sure dear
Change in shipper size in secondary packing is also an example of planned deviation
Sorry dear any how I just skipped your question.It depends that if the change is temporary and preplanned then it would comes under planned deviation.
Superb video sir, change control ka video banayi na
Thanks dear for liking d video, well dheera dheera sare topic cover karne ki koshish hai, waise agar achcha laga hi to plz video ko share or channel ko subscribe zaroor kijiyega
Well done Sir ... So easy way to Explain ...
I think you have pharmaceutical Employee ?
Thanks dear yes I am a pharma employee
Dear Sir
Please explain what is the difference between Deviation and Event in pharmaceutical industry and give examples. I am confused literally between which one is deviation and which one is event. If one person did not wear his gowning in production is this event or deviation? One manufacturing step not followed is this event or deviation ?
well dear i already explain d same to one of my subscriber. you may read d explanation on my video for deviation's comment box.
Kindly share topic
Cleaning validation
Market complaints
APQR PQR
FMEA
Sure y not, but as I told earlier that due to lock down I am stocked somewhere, as soon d lockdown get withdraw, I will post my new videos.
Godd sir
Dear sir ,
Thanx a lot for explaining nicely about deviation!
I hv some doubt like if in my STP no of blank injections mentioned 2 but by mistaken I gave one shall we consider as a deviation!
Second during analysis if I forgot to give entry in log book!!
Well dear in this case you may raise a incident because now you cab not rectify you mistake in same sequence , you need to repeat he sequence that's why you need to raise an incident.
@@loveforpharma934 thanx a lot sir!
Veri nice sir
🙏💕 thank u so much love ❤😘❤😘u
Sir aise hi aage bhi
Gmp vs cgmp??? Btaaiyega??
Okndear thanks n ofcourse
Sir change control KO bhi btayiye
sure dear
Please make a video for change control
sure
Very useful
Glad you think so!
Sir deviation ke liye investigation kar na ho to kon kon se document collect kar hoga
Deviation k liye us particular deviation se related har important docs collect karne honge matlab jo kuch b us deviation se associated hai
Hlo sir kindly give knowledge of warehouse Department
any specific point or general
Sir how we can close planned deviation, this also required change control to be close with deviation?
If there is any permanent change which is caused by that particular deviation then only u need to take change control, other wise you close the same by prescribed format.
@@loveforpharma934 ok thanks sir
Explanation very simple Sir
Please explain 21cfr & urs
well you may watch mu video on ALCOA and i will capture urs in my next video.
Thanks sir..
welcime dear
Thanku sir nice video aap sir change control and qms ke baare me discuss kijiye
Definitely dear, these days I am quite busy with some of my personal issues, but very soon I will share videos on said topics. THANKS FOR LICKING D VIDEO. PLEASE SHARE THE VIDEOS WITH YOUR KNOWN ONES.
Sir app age ki video kyu nhi bna rhe please change control pr bnayiye
well dear agar aapne gaur kiya ho to mai just kisi guidline ko padta nahi hu balkj use is tarah se narrate karne ki koshish karta hu ki wo easly kisi ko b samajh aa jaye ir aisa karne k liye muze kafi time dena padta hai. filhal mai apne kisi or project me busy hu or isis liye video nahi bana pa ra hu but jaldi hi banaunga aap logo k liye.THANKS
Explain about Equipment periodic qualifications necessaries?
Will capture in my another video
I like it
sorry for late reply and thanks a lot to loke d video
Sir please discribe different b/w incident and unplanned deviation
Dear incident is an unrecoverable accident which happen unintentionally, while an Unplanned Deviation is an activity which we may do intentially and the same could be recoverable
@@loveforpharma934 please make a clear video on this sir
Good topics sir I like it but now a daya's peoples are saying planned and unplanned deviation are closed
Well dear it's right, but if you will see my video about difference between GMP and CGMP, there I explain that to execute new guidline really takes time, same is in this case it is till low not mandatory, as B grade and C grade company can't perform their activities without Deviations.
Sir mixing of 2 different batches ye kiske under aayega ...major deviation ya phr critical deviation ke under ??
Dear it will come under incident
Critical
Gmp and CGmp bhi btayiye please
ruclips.net/video/-dB7rqII6ic/видео.html is the link for my video about difference between GMP N cGMP
Sir plz make vedio on three types of stability chambers used in quality assurance pharma ( long term , short term or intermediate term stability chamber and accelerated term stability chamber )
Ok dear ofcourse
@@loveforpharma934 Thanks a lot sir
@@loveforpharma934 sir plz also explain on what basis medicines or products are placed in different chambers ?
Sir i is there any event/source except deviation that lead to capa ??
CAPA is taken for any incident, market complain or any other activity which leads failure and its investigation.
@@loveforpharma934 thank you sir
The presentation is very good but what about the impact assessment ........need to addreesed during handling of deviation....
Thanks dear for liking the video, obviously impact assessment is a part of Deviation but it is itself a complete and big topic, so will surely capture under my another video.
sir can u plz upload a video about IQ,OQ and PQ document sample with example
Dear I think u didnt subscribe my channel otherwise you must know abt my latest video, which is for IQ, OQ, PQ, DQ and other qualification parts. Just go to my channel and watch d video
I went through those but those have only explainations about what IQ,OQ and PQ is not the whole document sample....
@@haribasyal2234 well dear whole documents can't share sorry
@@haribasyal2234 but I will try to share d samples, ok
@@loveforpharma934 thank you sir
But apne ye nhi btaya ki kitne din mai ise close krte hai aur agr utne bhi nhi ho paya close fir kya karte hai??????
Of course dear, every activity should complete within a time frame and the same should mention in your respective SOP, any deviation in said time line should cover under Unplanned deviation.
Sir ye kahe rhe h ki data integrity?? And alcoa bhi batayega??
Of course dear as I said one by one I will try to cover every technical and non technical point, but obviously it will take time. To prepare a single video it take lot of efforts and time so keep patience and weight.
Ok thanks hm wait krenge?
Sir can you please explain the difference between unplanned deviations and Non conformity report
NCRs are the activities performed intentionally or unintentionally by some persons, which were not as per your standard procedures.
@@loveforpharma934 machine ki speed agar limit se bahar ho production fast krne ke liye to ye NCR ke under aayega ya unplanned deviation ... As per Ur definition NCR ke under because ye ek person kr rha hai ?
Dear m/c ki limit always m/c QUALIFICATION or product validation k samay verify kar li jati hai jaise minimum medium or maximum, yani ki m/c ki maximum limit par hum apne product ko chala k pahle hi validate kar chuke hote hain, is liye machine ki speed limit badhana Deviation nahi hota until unless it should mentioned in your BMR or BPR
And as I said ki wo activities which seems like accident may come under incident and also which were near to recover, machine ki speed kabi b accidentally nahi badri hai hamesh intentionally badaya jati hai or use ham jab chahe change ya manage kar sakte hain
@@loveforpharma934 ok sir thnku
100 Percent satisfied with Ur answer 👍
Plz tell me difference between non compliance n Incident......
well dear, non compliance is when you dony obey the SOPs, protocol or other written procedures. It may intentional or unintentional. on the other hand incidence is an uncontrolled event or accident which probably take palce un intentionally.
@@loveforpharma934 but if we don't follow the written procedure it is called deviation.......
@@unpluggedartist2466 yes dear there is again difference between incident and Deviation.
@@loveforpharma934 Dear sir I just want to know difference between non conformance n incident.....
@@unpluggedartist2466 dear when we do not follow d written procedures it would definitely a Deviation. The chalan what we raised to address that Deviation or such things is known as NCR or non conformance report.
Media filling ke bare me batao
Well dear sure but abhi kuch or videos pipeline me hai, so after those videos
Kindly tell me the Tcd of deviation
Good question dear, actually the exact TCD is not mentioned in any of guidline but it depends on the type of Deviation generated. We shall categories the TCDs for Deviation in justified way in our SOP.
Walk the Talk
Amber bottle breaking during filling ..ye incident ke under aayega ya phr unplanned deviations ??
Definitely it's a incident, actually incident ko moti tarah se samajhna chaho to jo activities accident ki tarah ho or jo almost non recoverable ho wo hamesha incidence me aati hain, jaise koi spillage.
@@loveforpharma934 Thanku so much sir
Wais bahot sare log Unplanned Deviation ko hi incident me cover karte hain, but it's a point of common sense ki ek hi cheez ke liye do terminology kyo hogi kya kisi or cheez ki do terminology hai pharma me????
@@loveforpharma934 yes u r right sir
Sir agar koi person without gowning enter krta hai area me to ye unplanned deviation ke Ander aayega . Bt as per Ur definition of NCR ye Non conformity report ke under bhi aa skta hai ??
Mera jo doubt that unplanned deviation or incident ka vo to 100 percent clear kr diya Apne bt I m still confused between unplanned deviation and NCR
Procesor to btaya ni
????
Slide is not visible
Not visible means, will u please tell me, coz no body complain me till, d video is already have thousand of views
Thanks you so much
Good morning sir
Gud morning dear
Hii
Hi
Deviation hota kya h...iska matlab h kya...🤔🤔🤔
well dear you may go through my video for deviation ruclips.net/video/Cbum6ZZASgQ/видео.html, this is d link.
Please make video on change control and other QMS
Nice
Thanks