Pharmaceutical Water System - Key Questions and Answers

#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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[@abhishekgupta-pharmers5231]

Very helpful,, ✌

[@hitendrakumarshah3718]

Thank you for your kind comment

[@prasangitv3658]

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

[@hitendrakumarshah3718]

For deviation, you can go through the link - th-cam.com/users/livexuijsumCDnI?feature=share
For change controls - th-cam.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.

[@GXPTraining]

Good Evening

[@hitendrakumarshah3718]

Good evening

[@GMPTRAINING]

I will be online 20:00 hrs

[@hitendrakumarshah3718]

Thanks

[@GMPTRAINING]

Welcome@@hitendrakumarshah3718

[@vishalszzz3ehgal843]

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.

[@hitendrakumarshah3718]

Yes. i suggest, you can go through USP chapter. It is very clear on objectionable organisms.

[@GXPTraining]

Yes sir waiting

[@hitendrakumarshah3718]

Hope you’ve attended the session

[@GXPTraining]

Yes sir@@hitendrakumarshah3718

[@AUDITS-wm2dg]

waiting

[@hitendrakumarshah3718]

Thanks

[@AUDITS-wm2dg]

welcome@@hitendrakumarshah3718

[@Training-rt3ng]

Waiting for training

[@hitendrakumarshah3718]

Thanks

[@Training-rt3ng]

Welcome@@hitendrakumarshah3718

[@vijay18panneer]

Hi sir,
Long back pending kindly make HVAC related video as per request....

[@hitendrakumarshah3718]

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.

[@vijay18panneer]

@@hitendrakumarshah3718
ok noted sir, if you don't mind let me share my HVAC guidelines reference and documents, if you are ready to agree.

[@proogamerop5266]

Waiting for today's session

[@hitendrakumarshah3718]

Thanks

[@veeraganesh1902]

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

[@SantoshGoswami1984]

Is it compulsory to have RO system in pharmaceutical water system in a liquid oral facility? If yes, which guideline specify this?
Please guide

[@hitendrakumarshah3718]

RO is not compulsory for liquid orals. The ion exchanges will increase the possibility of nitrosamine impurities. So, it is recommended.

[@vishalszzz3ehgal843]

Sir do we need to perform endotoxin tests for Oral liquid products

[@hitendrakumarshah3718]

Endotoxin testing is not required for oral liquids.

[@proogamerop5266]

GE

[@hitendrakumarshah3718]

Good evening

[@AUDITS-wm2dg]

how to do and review trends?

[@hitendrakumarshah3718]

I am preparing for trends video for next week

[@AUDITS-wm2dg]

Thanks@@hitendrakumarshah3718