Pharmaceutical Water System - Key Questions and Answers
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- čas přidán 15. 12. 2023
- #pharmaceutical #quality #pqs #fda #europa #who #gmp #ich #water
This learning video will discuss below questions and answers in line with the regulatory guidelines.
If you have any question/s, please put your questions in the comment section. I will reply to you.
1. Is it enough to perform testing for total microbial count and Indicator organisms on pharmaceutical water samples?
2. Does the non-sterile API manufacturer need to perform testing of purified water for endotoxins?
3. Is it required to check the water system drawing/layout yearly?
4. Is it mandatory to have a drawing/layout print for the water system?
5. Do the agencies expect to have Pass/Fail limits for water for pharmaceutical use?
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Very helpful,, ✌
Thank you for your kind comment
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 - czcams.com/users/livexuijsumCDnI?feature=share
For change controls - czcams.com/users/liveNjBO8TN_0XI?feature=share
You will get all learning. Just type Hitendrakumar Shah in youtube and go to videos and choose and learn free.
Good Evening
Good evening
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.
Waiting for training
Thanks
Welcome@@hitendrakumarshah3718
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.
Yes sir waiting
Hope you’ve attended the session
Yes sir@@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.
waiting
Thanks
welcome@@hitendrakumarshah3718
Waiting for today's session
Thanks
I will be online 20:00 hrs
Thanks
Welcome@@hitendrakumarshah3718
Sir do we need to perform endotoxin tests for Oral liquid products
Endotoxin testing is not required for oral liquids.
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
how to do and review trends?
I am preparing for trends video for next week
Thanks@@hitendrakumarshah3718
GE
Good evening