Cleaning Validation

  Рет қаралды 14,053

Hitendrakumar Shah

Hitendrakumar Shah

Күн бұрын

Пікірлер: 58
@hitendrakumarshah3718
@hitendrakumarshah3718 5 жыл бұрын
This training video will insight on Cleaning Validation - Inspection observations, Visual clean criteria & Solving practical problems during cleaning validation.
@manoharkallapari8765
@manoharkallapari8765 3 жыл бұрын
Sir plz do videos about cleanability study,DEHT and CEHT
@hitendrakumarshah3718
@hitendrakumarshah3718 3 жыл бұрын
Sure
@shahrzadtalebian8086
@shahrzadtalebian8086 4 жыл бұрын
very informative. I subscribed to your channel and watched most of your videos. Subtitle is always useful. Thanks for adding it. Now I can follow and understand your explanations.
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thanks and welcome. Keep Learning !!! The video will be available soon on,"Inspection Readiness for computerised systems". You will get notification shortly about it if, you have activated notification icon(BELL) button.
@mahendrasinhchavda3948
@mahendrasinhchavda3948 3 жыл бұрын
Sir very useful video for me 👌
@hitendrakumarshah3718
@hitendrakumarshah3718 3 жыл бұрын
Thank you so much for your kind comment !!!
@sreekanthPamidimarri
@sreekanthPamidimarri Жыл бұрын
Voice re sound is coming in most of the videos ,if it rectify more advantage to audience
@hitendrakumarshah3718
@hitendrakumarshah3718 Жыл бұрын
OK
@PankajSharma-ym4je
@PankajSharma-ym4je 4 жыл бұрын
Helpful video sir, please provide information about CV for TF
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Sure. What do you mean by term TF. Please confirm.
@MohsinKhan-ix9ws
@MohsinKhan-ix9ws 5 жыл бұрын
Respected sir plz make video on audit trail and it's compliance and how to check audit trail
@hitendrakumarshah3718
@hitendrakumarshah3718 5 жыл бұрын
Sure. We will work on this
@hitendrakumarshah3718
@hitendrakumarshah3718 5 жыл бұрын
Hope, you watched video on audit trail
@shivkumarbeenaboina5853
@shivkumarbeenaboina5853 4 жыл бұрын
Dear sir please make a brief video on environmental monitoring program in formulation (injectable).
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Sure. Thank you so much for sharing good topic.
@venugopalsriram
@venugopalsriram 2 жыл бұрын
Can you please provide the qualification procedure of person for visual cleaning
@hitendrakumarshah3718
@hitendrakumarshah3718 Жыл бұрын
You can qualify the person/operator after cleaning and testing the swab or rinse residue.
@PankajSharma-ym4je
@PankajSharma-ym4je 4 жыл бұрын
Sir TF means Topical formulation, how calculate MACO for all criterias for TF
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
I suggest, you can go through complete cleaning validation package. You will get information on all sort of dosage forms.If you have any questions, please feel free to comment. Will revert you. You can access the cleaning validation package through the link below; kzbin.info/www/bejne/sHKYqaaNh558i5o
@JC-qu1se
@JC-qu1se 4 жыл бұрын
Sir i have a query for one cleaning validation. If my product concentration is 50 MCG per ml And batch size is 275 litre. What should is acceptance criteria.
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
We can not just evaluate by referring this information. I suggest, you refer our cleaning validation part- II for better understanding. I am sharing link for the same. kzbin.info/www/bejne/sHOvooWQaqmLjJY
@gauravsharmamtvnlvideos
@gauravsharmamtvnlvideos 4 жыл бұрын
Sir, please give the training about how to do cleaning validation as per fda guidelines
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Dear Gaurav, I will really like to take training on this topic, if approximate 10-15 participants are available. Request you to check with your subordinates and friends. Please confirm.
@ashishjain412
@ashishjain412 4 жыл бұрын
@@hitendrakumarshah3718 I am interested for cleaning validation topic
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
@@ashishjain412 Sure. We will take up this topic as well.
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
@@ashishjain412 We will plan next week for online training(webinar) on cleaning validation.
@aneeshkumarpatel2811
@aneeshkumarpatel2811 4 жыл бұрын
A lot of thanks, very helpful.
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thanks for your kind comment
@MrKrish1029
@MrKrish1029 4 жыл бұрын
Is this cleaning validation shall be done with respect to every product on every equipment?? suppose in a non dedicated commercial manufacturing plant product A manufactured 10 batches on a row and for first three bathes company has performed cleaning validation, established dirty equipment hold time and cleaned equipment hold time as well, after product change over product B is going to manufacture in same equipment train which are used earlier for product A, now product A cleaning procedure, dirty hold time and cleaned equipment hold time is applicable for product B or not, please clarify.
@hitendrakumarshah3718
@hitendrakumarshah3718 3 жыл бұрын
I suggest you to go through below two recorded webinars to get more understanding kzbin.info/aero/PLq7ln35Rt1rMN52n2o3t_nH0lpmZShkZ6
@abhijeetgaikwad4202
@abhijeetgaikwad4202 4 жыл бұрын
Will you provide IPQA whole resposibilities
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
The responsibilities are inprocess at shop floor, evaluate critical process parameters, evaluate cleaning activities and give line clearance before going ahead for new product so as to protect the next product from contamination. Now a days, IPQA role is considered as Quality facilitator.
@venkatakrishnaanil
@venkatakrishnaanil 4 жыл бұрын
Good presentation
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thanks for your kind comment
@shobhalatha5048
@shobhalatha5048 5 жыл бұрын
Informative and helpful for professionals Post DI Issues Videos
@hitendrakumarshah3718
@hitendrakumarshah3718 5 жыл бұрын
Sure. The upcoming video will be DI issues and audit trail compliance. Thanks for your suggestion
@hitendrakumarshah3718
@hitendrakumarshah3718 5 жыл бұрын
Hope, you watched the DI video. kzbin.info/www/bejne/j4bWq4F9mpuIr80
@myfriends446
@myfriends446 5 жыл бұрын
Good explanation Sir...
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thanks for your kind comment
@yashshah8706
@yashshah8706 5 жыл бұрын
Very nice and helpful.
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thank you dear
@cosmeticgmp
@cosmeticgmp 4 жыл бұрын
good work, thanks!
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thank you so much for your kind appreciation. If you need any support, please feel free to contact me.
@Vikayadavbpharmhhhh
@Vikayadavbpharmhhhh 4 жыл бұрын
How to perform for vaccine
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
For cleaning validation after vaccine product, we need to evaluate what factors will impact on next products e.g. antigens of previos virus vaccines, the chemicals used for attenuation etc. We need to evaluate traces of these antigens or chemicals. It all depends on process followed. If you specify in detail, can guide you in better way.
@yogeshkhule5456
@yogeshkhule5456 4 жыл бұрын
Nice video
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thank you so much for your kind comment
@akashrathore8630
@akashrathore8630 4 жыл бұрын
Needed good editing
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thank you so much for your kind comments
@shailendra1277
@shailendra1277 5 жыл бұрын
Excellent Hitendra.
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thank you dear
@shirishareddyvlogskurnool6605
@shirishareddyvlogskurnool6605 4 жыл бұрын
Voice was dnt good ....pls request before taking vidoe pls make ensure and do it all
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
You are right. In this video, I have not used collar mike hence resulted in to some echo. After this video, I started using collar mike.
@DineshYadav-ni2cm
@DineshYadav-ni2cm 4 жыл бұрын
For general cleaning watch below presentation, then after CV, kzbin.info/www/bejne/rqebo6qjgMpjhc0
@hitendrakumarshah3718
@hitendrakumarshah3718 3 жыл бұрын
Good
@ashishjain412
@ashishjain412 4 жыл бұрын
Nice video
@hitendrakumarshah3718
@hitendrakumarshah3718 4 жыл бұрын
Thank you so much for your kind comment
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