PROCESS VALIDATION I PART-1 I INTRO I IMPORTANCE I HINDI
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- เผยแพร่เมื่อ 30 ก.ย. 2024
- Address for person and students who are interested in training and consultancy service-
B.R. NAHATA COLLEGE OF PHARMACY, NEAR KRISHI UPAJ MANDI, MHOW- NEEMUCH ROAD,
MANDSAUR (M.P.) 458001
PHONE NUMBER-9501846476, 9630301810
E MAIL ID-(1) DIRECTOR.BRNCOP@MEU.EDU.IN (2) KARAN.GUPTA@MEU.EDU.IN
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Disclaimer - video is for educational purposes only. Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for "fair use" for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational, or personal use tips the balance in favor of fair use.
THANKS FOR WATCHING.
#VALIDATION #PROCESS #QA #QC #PHARMA #INDUSTRY #NAUKRI #JOB #INTERVIEW
I like your teaching style
Sir sample size kaise decided karte hai kitna gram kis stage se lena hai
Please try to do your courses in English to reach larger audience (at least provide English subtitles). I am Algerian, very interested in the subject but unfortunately I don't understand you.
one correction . Process validation is a continuous process. Concurrent validation is life long process undertaken in different time phases. e,g, new product, first 30 batches data collected at each and every stage is thoroughly scrutinized. after this QA will suggest different time line,e.g.every 15the batch for 6 months, every 50th batch for 1 yr etc. Any repairs undertaken may also need re validation ( same by same Vs same by different) , off course not of the whole process. Actually posting of new person ( promotions, change of job etc)for handling of critical process also may need re validation. 3 M ( Man,Material and Machinery) issue.( All these details will take around 10 lectures)
Good morning sir.. I am vishal Yadav from lucknow pursuing b. Pharm 3rd year 5th semester.............. Sir mujhe industry training karna hai........... But mujhe koi ideas nhi h kaise aur kaha se karuu........ Aap kuch help kar sakte hai???
After send sample marketing. Stability study ,continous shelf life plus one year.
Yes, under the advised storage conditioons (validated)
Guru g kya aap materials se related series bna skte ho ? Complete characteristics of API and Excipients..5-10 in each video.
Please make a video for vendor questions and related certificate/declarations like a TSE BSE ,GMO etc and importance of this declarations
Sir ek question h mei basically DRA mein work krta hu regulatory affairs mei to hmne PV dossier wmi atatch kr k bhejte h outside from india toh unka ek question tha k ye PV konse type ka h to hum usme retrospective denge na sir answer mei
Can you please make video on system suitability parameters and calculation... thank you
Sir can you update GC calibration
One of my most awaited topic by karan sir😉😊
Jabardast
Plz suggest which guidance use for process validation
sir i watched your every video and everytime i learnt in brief i think u shld open a training centre in baddi too as it is pharma hub.I want to learn QC instruments but there is no training centre.
Sir aap acha explain karte ho
But jyada lenghthy ho jata hai
Make some videos on MEDICAL DEVICES INDUSTRY PLSSSS
How one can validate process for determining the a sodium benzoates in ketchup by spectrophotometer
Forgot one more thing. Small batches produced in /by QC, have to have a logic. e.g. parameters
defined after making batch of 1000 tabs/product can not be extrapolated to make a batch of 100000. In this example it is good idea to make batch of 15000-25000.
Well explained
Thank you sir
Sir double door autoclave , calibration and validation ka video bano ... Aap
Nice sir..
👍
Are sir jo topic he wahi sikha de na re baba tu...exam ke pehle hi dekhte video students aapko kya lagta hai free time mai yahi dekhte hai kya....pura history mai jate hai koi jururat bhi nai
Good explanation sir for process validation
Sir Exhibit Bach k bari Ak video bana do pzz
Why u repeat one sentence 4 to 5 times..😅😅
Also known as preformulation
To much easy ...... thank you
Bahut achha explain karte hai sir
Nice explanation
Thanks sir ji 🎉
Wow , mujhe sab samaj raha hai
Very nice
Liquid department me process validation kaise karte hai is bare me details chaiye
1 fandamental bat yad rakhiye. Har wo chiz/bat/action jisase product reliability pe farak pad sakata wo bilkul documented correct honi chahiye.Har product ki jaroorate alag hoti hai, Basic samaz gaye to khud hi design kar sakenge.e.g. koi bhi liquid agar final product me jane wala hai to uske liye ss316L containers/pipeline hi use honge 306 nahi chalega.
thanku sir 🙏
Sir agar process validation mai document main wrong entry ho jaye to kya hoga?
Pahale ye proove karana padega ke sirf" entry galat hai"( human error). (e.g. 1.1 ki jagah 1.01 likha gaya)Isiliye sara raw data, calculations= sheets rakhani padati hai.Sara raw data study karake QA data correction karega. data correction me whitener ect nahi chalega purana data strikethrough karake nayi entry countersignature ke sath QA approve karega.
Aur sir agar A.R no Generat nahi kiya he means TR recieved nahi hua he aur analysis ho gaya he aur TR par sign/date bhi laga diya he to kya kare?
Thnx sir❤
🙏🙏🙏🙏
Sir HPLC ka validation ka video hai kya ??
Nice