Hello sir I have gone through the full video here it's fantastic one. I am willing to know that what is the role of a microbiologist in purified water validation for pharmaceutical use or what does the microbiologist do in the validation of purified water in pharmaceutical use.
Hello, do we need alert, action and specification limits for toc, endotoxin, conductivity or only microbial load? Since Conductivity goes though multi stage testing how to calculate alert and action limits? Appreciate your response
Pls tell me any reference guidelines available for clean and unclean hold period of equipment and accessories used for manufactring of OSD formulation.
As per EU guide- "The influence of the time between manufacture and cleaning and the time between cleaning and use should be taken into account to define dirty and clean hold times for the cleaning process". I need to check FDA requirement. Hope, this will solve your purpose.
Is it really required to perform complete validation after modification(loop length decrease or increase) even after technically ensuring my pump capabilities, performing sanitization, loop cleaning, initial results comfortably meeting specifications? Mostly if water fails in course of validation (phase 3) the reason might not be the above cited change, pls clarify.
When any thing is planned, first change control should be raised. After that, QRM should be performed. On the basis of QRM, URS should be prepared considering all identified risks during QRM so that, after following URS, all risks can be mitigated. Hope, it is clear.
Plz share pdf lecture of yor video or book or collective information about each topic or water system guidelines, ip bp, usp, jp, who... Very useful for us,..
I wish to use water in manufacturing during phase 1(after 3 days results) , but I will release batches to market after phase 2 conclusion, can you explain the practical difficulties rather than guideline recommendations.
Good Manufacturing Practices are set of rules. The guidelines are on the basis of these GMP set rules. We should not make practice to break these rules. Many people will do risk assessment to justify. Let me tell you , QRM can not be used to justify the wrong things. Hope, you got the idea why we should not deviate.
My system is very old and membranes are not hot sanitizable,we are cleaning with chemicals meant for removing fouling only, furthermore results are meeting, Is it mandate sanitization for generation system?
Sir if purified water system and distribution loop in stop condition for 1 month due to plant shut down then we have do again all three phase validation or only 3rd phase validation, pls. Confirm?
Dear Sir you stretch unnecessary videos meaningless.. Because what are water quality as how many cfu in different category of water as purified water,water for injections and process water and may more things about your topics you make a slide details and go one bye one.... Please..
Dear sir please make a video on water treatment from raw water (source water) up to pure steam generation step by step process flow chart in formulations injectable plant briefly.
@@muthinenishravankumar3581 Why there is delay in starting phase 2. Why there is delay from 14/01/2020 to 01/02/2020? Ideally, We have to a further test period of two weeks after phase 1. Hope you are clear.
In distribution line purified water temperature is 70 C maintained...in presentation not discussed this point..kindly confirm that its mandatory requiremwnt...
The training was fully focussed on water system validation. You can monitor the temp as part of life cycle approach. (Please refer the content.) It will be detailed training and require about 2 complete days. Where we can discuss all the aspects with respect to designing, and many more....
I suggest, it is not required. As, water will be in continous circulation, you can have same alert and action limit for all sampling points. However rationale should be provided.
Due to variation in the pipe diameter or uses or any other reason, if the possibility of stagnancy of water can not be avoided, this is called dead leg. Hope, this will clear you.
If a point exceeds more than 1.5 times w.r.t main branch dia considered as dead leg, the water from that zone can't be mixed continuously with loop running water which results microbial proliferation.
Pls tell me any reference guidelines available for clean and unclean hold period of equipment and accessories used for manufactring of OSD formulation.
As per EU guide- "The influence of the time between manufacture and cleaning and the time between cleaning and use should be taken into account to define dirty and clean hold times for the cleaning process". I need to check FDA requirement. Hope, this will solve your purpose.
yes sir, your audible,Your presentation is very interesting and learning...thank u so much for great session
Thank you
Hello sir I have gone through the full video here it's fantastic one. I am willing to know that what is the role of a microbiologist in purified water validation for pharmaceutical use or what does the microbiologist do in the validation of purified water in pharmaceutical use.
Monitoring, sampling, testing, data evaluation, recommendation should be done by microbiologist
Hello, do we need alert, action and specification limits for toc, endotoxin, conductivity or only microbial load? Since Conductivity goes though multi stage testing how to calculate alert and action limits?
Appreciate your response
Hi; I suggest that wherever you have monitoring controls, you need to have an alert and action limit along with the specification limit.
Thanks for sharing your knowledge and experience, it's really helpfull.
Welcome. Keep Learning !!!
Sir how to do the sanitization of air vent filter after intergrity test, before refix into the PW / WFI tank housing.
You can do heat sanitation. Also, the filter should have heating provision.
Pls tell me any reference guidelines available for clean and unclean hold period of equipment and accessories used for manufactring of OSD formulation.
As per EU guide- "The influence of the time between manufacture and cleaning and the time
between cleaning and use should be taken into account to define dirty and clean
hold times for the cleaning process". I need to check FDA requirement. Hope, this will solve your purpose.
If their is 2 DI plant for purified watet...on laternate basis its operates... Validation will be done seperate or can be combined...
You need to ensure performance of the both plants.
Is it really required to perform complete validation after modification(loop length decrease or increase) even after technically ensuring my pump capabilities, performing sanitization, loop cleaning, initial results comfortably meeting specifications?
Mostly if water fails in course of validation (phase 3) the reason might not be the above cited change, pls clarify.
Yes. After modification, complete validation is required. Please refer again the recorded webinar for details. Same is discussed duirng Q&A session.
Why URS was placed after risk assessment. URS should be before the change control itself or not?
When any thing is planned, first change control should be raised. After that, QRM should be performed. On the basis of QRM, URS should be prepared considering all identified risks during QRM so that, after following URS, all risks can be mitigated. Hope, it is clear.
Hi sir,
All your video very must infromative thanks for all and kindly drop any video about HVAC guidelines & process....Audit experience to us.
Sure. Will prepare separate video on this
When will effective Sop before start of phase 1 or after phase I
Phase 1,2 and 3 are part of PQ. So, SOP should be effective before phase-1
Sir if we planned to buy a new equipment. i.e. blister packing machine. Do we need a change control for this?
Yes. Ofcourse !!!
Thank you Sir
anil pradhan welcome. Keep learning!!!
Plz share pdf lecture of yor video or book or collective information about each topic or water system guidelines, ip bp, usp, jp, who... Very useful for us,..
Sure. Will make it. Thanks
I wish to use water in manufacturing during phase 1(after 3 days results) , but I will release batches to market after phase 2 conclusion, can you explain the practical difficulties rather than guideline recommendations.
Good Manufacturing Practices are set of rules. The guidelines are on the basis of these GMP set rules. We should not make practice to break these rules. Many people will do risk assessment to justify. Let me tell you , QRM can not be used to justify the wrong things. Hope, you got the idea why we should not deviate.
My system is very old and membranes are not hot sanitizable,we are cleaning with chemicals meant for removing fouling only, furthermore results are meeting,
Is it mandate sanitization for generation system?
Yes. Sanitation of generation system is required. The fowling smell is due to microbial load. You have reduce the load at generation step also.
Yes
Periodic revalidation on frequency based is required or not? One time activity is enough and routine monitoring will be done kindly clear plzzz...
Yes. We need to reevaluate the water system periodically.
3 phases will be repeat ? Accordingly for perioidic validation
Wasim Iqbal Not required. You need to re-evaluate the system. That’s it
Sir our water failure occurre during first phase of validation then what we will do ?
First need to investigate, solve the problem from the root and then again perform phase-1
I need one question why yu are performed BET Purified water?
Pls sent answer..
NO. BET and Sterility test is not applicable for purified water. Also, I dont recommend to perform for purified water.
Could you tell the guide specifying about the slope 100:1 for loops,UV intensity requirement against flow.
You can refer IS guide
How to make specifications for each stage? That is ro 1, ro2, soft water etc? While doing performance qualification
The specification should be prepred based on functional roles of the stages for purification.
Yes very well your prasentation
Thanks
Sir can you also provide guidance for water skip testing
The skip testing for water based on many parameters - online controls, design, process controls, and finally trend data.
If TOC online not placed even in QC TOC not performed due to instrument out of order...what is alternate in phase 1 and 2 testing...plz answer
Not clear. Whether you have only online TOC? Or even you dont have any TOC? Please provide clarity
We havent online TOC installed..in purified water plant
Although in QC lab Offline TOC also out of order...we can test oxidizable substance as per BP specs
Wasim Iqbal No
Wasim Iqbal ok. I suggest you need to have online TOC
Sir if purified water system and distribution loop in stop condition for 1 month due to plant shut down then we have do again all three phase validation or only 3rd phase validation, pls. Confirm?
Yes. We need to perform complete sanitation and followed by complete validation.
Its only required 7 days study i.e. requalification and not need for phase 3 study
Please add a closed captioning option, it helps those with hearing loss.
Sure. Will do it
What should be the temperature limit of supplied purified water and how to determine the limit
Can you please clarify in more details. I need more clarity about the question.
Sir please correct in slide Average + 2 Sigma is alert limit and average + 3 Sigma is Action limit
Correct. Its an error. Thank you for kind comment.
thank u sir how to write water qualification step by step please explain
You can raise exact question - I will guide you
Kindly share video on 'Cleaning & Sanitization ' process for RO Membrane with concentration of cleaning & Sanitizing solution for 2 pass RO system..
I will prepare separate session.
Dear Sir you stretch unnecessary videos meaningless.. Because what are water quality as how many cfu in different category of water as purified water,water for injections and process water and may more things about your topics you make a slide details and go one bye one.... Please..
Sir types & usage of water system not visible properly. Please send it.
You can refer the recorded webinar by following the same link.
Dear sir please make a video on water treatment from raw water (source water) up to pure steam generation step by step process flow chart in formulations injectable plant briefly.
Sure. Will prepare on the same
Sir can you make a video on qualification of analytical equipments like uv, HPLC, ir etc
Sure. I will prepare and conduct training on it.
Your presentation is very interesting and learning...thank u so much for great session
Welcome. Keep Learning !!!
How to address the gaps among the validation phases(immediate after completion, next phase has not started).
Sorry.. Not clear with your question.
@@hitendrakumarshah3718
Ex: I completed phase 1 from 01/01/2020 to 14/01/2020 and started phase 2 from 01/02/2020 to 14/02/2020.
@@muthinenishravankumar3581 Why there is delay in starting phase 2. Why there is delay from 14/01/2020 to 01/02/2020? Ideally, We have to a further test period of two weeks after phase 1. Hope you are clear.
@@muthinenishravankumar3581 for easy understanding in Hindi I will suggest you Pharma scholars
During phase 2 study, we can increase sampling point
No. During Phase 1 and Phase 2, the sampling point and frequency remains same.
In distribution line purified water temperature is 70 C maintained...in presentation not discussed this point..kindly confirm that its mandatory requiremwnt...
The training was fully focussed on water system validation. You can monitor the temp as part of life cycle approach. (Please refer the content.) It will be detailed training and require about 2 complete days. Where we can discuss all the aspects with respect to designing, and many more....
If thier is 2 pump one pump operate one time...then 2nd..if one stop can be chnces of biofilm formations...
No. Pump will only provide power. We just need to connect the pump to existing pipes.
a big fan sir...
Thank you so much for your comment. Please keep learning !!!
Yes. Audible
Thanks
Super sir
Thanks. Please keep learning !!!
Source of water change then what is require
You need to re-qualify existing system.
Dear Hitendra sir looking for your guidance
Sure...
Sir please share draft guidelines
Which draft guideline you are looking for. Please clarify. i will share link to access the guideline
@@hitendrakumarshah3718
Required process validation protocol and who gmp guidelines
YES
Thanks
Alert and action limit is different of each sampling
I suggest, it is not required. As, water will be in continous circulation, you can have same alert and action limit for all sampling points. However rationale should be provided.
Yas
Thanks
What is meant by dead legs
Due to variation in the pipe diameter or uses or any other reason, if the possibility of stagnancy of water can not be avoided, this is called dead leg. Hope, this will clear you.
If a point exceeds more than 1.5 times w.r.t main branch dia considered as dead leg, the water from that zone can't be mixed continuously with loop running water which results microbial proliferation.
yes
Thanks for confirmation !!!
Y
Thanks
Pls tell me any reference guidelines available for clean and unclean hold period of equipment and accessories used for manufactring of OSD formulation.
As per EU guide- "The influence of the time between manufacture and cleaning and the time
between cleaning and use should be taken into account to define dirty and clean
hold times for the cleaning process". I need to check FDA requirement. Hope, this will solve your purpose.