Hello sir , could u plz do video on. Deviation and investigation, take examples per example in-process reading out of limit or product mix up or foreign partical found in product, or yield out of limit plz take example and explain ,if is there already video plz do share link , its humble request
For deviation, you can go through the link - ruclips.net/user/livexuijsumCDnI?feature=share For change controls - ruclips.net/user/liveNjBO8TN_0XI?feature=share You will get all learning. Just type Hitendrakumar Shah in youtube and go to videos and choose and learn free.
You need method and specification. The method validation is not required as the method is pharmacopieal methods. But yes, method verification is required.
Sir, In a multiproduct oral solid and liquid product facility what approach shall be followed for identfication Of objectionable organisims. I mean specific methodology over and above the high level stratergy given in guidance.
We want to install UV treatment for our water plant for intermediate production. and this water is obtained by ion exchange method. But we are confuse either install UF or UV. Can you guide plz. Sir
Hi sir thanks for information, I'm A chemist in manufacturing department in API pharmaceutical industry......is there any courses that are use full to me for better knowledge in manufacturing
Sure. Actually i am looking for some good material. Everyone is aware about ISO 14644. Also, I am looking for good pictures to make clear understanding.
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Hello sir , could u plz do video on. Deviation and investigation, take examples per example in-process reading out of limit or product mix up or foreign partical found in product, or yield out of limit plz take example and explain ,if is there already video plz do share link , its humble request
For deviation, you can go through the link - ruclips.net/user/livexuijsumCDnI?feature=share
For change controls - ruclips.net/user/liveNjBO8TN_0XI?feature=share
You will get all learning. Just type Hitendrakumar Shah in youtube and go to videos and choose and learn free.
Is AMV required for those specifications and test procedures which are used during water system qualification.
You need method and specification. The method validation is not required as the method is pharmacopieal methods. But yes, method verification is required.
Sir, In a multiproduct oral solid and liquid product facility what approach shall be followed for identfication
Of objectionable organisims.
I mean specific methodology over and above the high level stratergy given in guidance.
Yes. i suggest, you can go through USP chapter. It is very clear on objectionable organisms.
We want to install UV treatment for our water plant for intermediate production. and this water is obtained by ion exchange method. But we are confuse either install UF or UV.
Can you guide plz. Sir
You need to evaluate why you need to install UV or UF? Are you facing any problem? The purpose of both units are different.
Sir do we need to perform endotoxin tests for Oral liquid products
Endotoxin testing is not required for oral liquids.
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Very helpful,, ✌
Thank you for your kind comment
Hi sir thanks for information, I'm A chemist in manufacturing department in API pharmaceutical industry......is there any courses that are use full to me for better knowledge in manufacturing
Yes. You can connect with me. I will guide you.
@@hitendrakumarshah3718 how can I contact you sir
@@hitendrakumarshah3718 how can I contact you sir
Yes sir waiting
Hope you’ve attended the session
Yes sir@@hitendrakumarshah3718
how to do and review trends?
I am preparing for trends video for next week
Thanks@@hitendrakumarshah3718
Is it compulsory to have RO system in pharmaceutical water system in a liquid oral facility? If yes, which guideline specify this?
Please guide
RO is not compulsory for liquid orals. The ion exchanges will increase the possibility of nitrosamine impurities. So, it is recommended.
Hi sir,
Long back pending kindly make HVAC related video as per request....
Sure. Actually i am looking for some good material. Everyone is aware about ISO 14644. Also, I am looking for good pictures to make clear understanding.
@@hitendrakumarshah3718
ok noted sir, if you don't mind let me share my HVAC guidelines reference and documents, if you are ready to agree.
Waiting for training
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Welcome@@hitendrakumarshah3718
Good Evening
Good evening
Waiting for today's session
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sir sanitaz vedio required
Sure
waiting
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welcome@@hitendrakumarshah3718
GE
Good evening