Pharmaceutical Water System Validation

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Pharmaceutical Water System Validation

Рет қаралды 19,083

Күн бұрын

This training session will take you through different regulatory agency expectations about pharmaceutical water system validation.
How practically someone can achieve the compliance and ensure validated state of water system.
What are the common errors or non conformance related to water system validation.
How to address the common problems arised during the water system validation.
Finally the session will have Q&A where all the queries shall be responded online.
NSF International, pharmaguideline,AA. Vedic Gyan. KD,PHARMA PORTAL,Prof.Karan Ajay Gupta,Pharma Pill,Vivekanand Education Society's College of Pharmacy,
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Пікірлер: 120

@perumallachinna568 3 жыл бұрын

yes sir, your audible,Your presentation is very interesting and learning...thank u so much for great session

@hitendrakumarshah3718 3 жыл бұрын

Thank you

@manoranjansasi Жыл бұрын

Yes. Audible

@hitendrakumarshah3718 11 ай бұрын

Thanks

@amandhanwal4682 Жыл бұрын

Sir how to do the sanitization of air vent filter after intergrity test, before refix into the PW / WFI tank housing.

@hitendrakumarshah3718 11 ай бұрын

You can do heat sanitation. Also, the filter should have heating provision.

@mkjha4897 Жыл бұрын

YES

@hitendrakumarshah3718 Жыл бұрын

Thanks

@NoorFatima-zc7ye 11 ай бұрын

Sir can you also provide guidance for water skip testing

@hitendrakumarshah3718 11 ай бұрын

The skip testing for water based on many parameters - online controls, design, process controls, and finally trend data.

@raqibansarii Жыл бұрын

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.

@hitendrakumarshah3718 Жыл бұрын

Monitoring, sampling, testing, data evaluation, recommendation should be done by microbiologist

@muthinenishravankumar3581 3 жыл бұрын

Thanks for sharing your knowledge and experience, it's really helpfull.

@hitendrakumarshah3718 3 жыл бұрын

Welcome. Keep Learning !!!

@kuldeepverma6124 7 ай бұрын

Yas

@hitendrakumarshah3718 7 ай бұрын

Thanks

@vijay18panneer 2 жыл бұрын

Hi sir, All your video very must infromative thanks for all and kindly drop any video about HVAC guidelines & process....Audit experience to us.

@hitendrakumarshah3718 2 жыл бұрын

Sure. Will prepare separate video on this

@krishnanvisva4137 Жыл бұрын

Super sir

@hitendrakumarshah3718 11 ай бұрын

Thanks. Please keep learning !!!

@plantedearth1543 2 жыл бұрын

Please add a closed captioning option, it helps those with hearing loss.

@hitendrakumarshah3718 2 жыл бұрын

Sure. Will do it

@ravindrajoshi3374 3 жыл бұрын

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,..

@hitendrakumarshah3718 3 жыл бұрын

Sure. Will make it. Thanks

@mohdazeemuddin8353 2 жыл бұрын

Yes very well your prasentation

@hitendrakumarshah3718 2 жыл бұрын

Thanks

@vaibhavshetkar3797 Жыл бұрын

How to make specifications for each stage? That is ro 1, ro2, soft water etc? While doing performance qualification

@hitendrakumarshah3718 Жыл бұрын

The specification should be prepred based on functional roles of the stages for purification.

@samvdio7513 3 жыл бұрын

Pls tell me any reference guidelines available for clean and unclean hold period of equipment and accessories used for manufactring of OSD formulation.

@hitendrakumarshah3718 3 жыл бұрын

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.

@saurabhmorparia Жыл бұрын

Sir can you make a video on qualification of analytical equipments like uv, HPLC, ir etc

@hitendrakumarshah3718 Жыл бұрын

Sure. I will prepare and conduct training on it.

@muthinenishravankumar3581 3 жыл бұрын

Could you tell the guide specifying about the slope 100:1 for loops,UV intensity requirement against flow.

@hitendrakumarshah3718 3 жыл бұрын

You can refer IS guide

@anjurani7258 Жыл бұрын

Sir our water failure occurre during first phase of validation then what we will do ?

@hitendrakumarshah3718 Жыл бұрын

First need to investigate, solve the problem from the root and then again perform phase-1

@nelijadias2467 3 жыл бұрын

What should be the temperature limit of supplied purified water and how to determine the limit

@hitendrakumarshah3718 3 жыл бұрын

Can you please clarify in more details. I need more clarity about the question.

@naweenbalodi251 3 жыл бұрын

Kindly share video on 'Cleaning & Sanitization ' process for RO Membrane with concentration of cleaning & Sanitizing solution for 2 pass RO system..

@hitendrakumarshah3718 3 жыл бұрын

I will prepare separate session.

@aryanvlogs1919 2 жыл бұрын

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..

@sreedevitv86 2 жыл бұрын

When will effective Sop before start of phase 1 or after phase I

@hitendrakumarshah3718 10 ай бұрын

Phase 1,2 and 3 are part of PQ. So, SOP should be effective before phase-1

@prabhukiran4431 Жыл бұрын

thank u sir how to write water qualification step by step please explain

@hitendrakumarshah3718 Жыл бұрын

You can raise exact question - I will guide you

@muthinenishravankumar3581 3 жыл бұрын

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.

@hitendrakumarshah3718 3 жыл бұрын

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.

@wasimiqbal9422 3 жыл бұрын

If thier is 2 pump one pump operate one time...then 2nd..if one stop can be chnces of biofilm formations...

@hitendrakumarshah3718 3 жыл бұрын

No. Pump will only provide power. We just need to connect the pump to existing pipes.

@shivkumarbeenaboina5853 3 жыл бұрын

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.

@hitendrakumarshah3718 3 жыл бұрын

Sure. Will prepare on the same

@mohammadmustaqbijapur4998 2 жыл бұрын

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

@hitendrakumarshah3718 2 жыл бұрын

Hi; I suggest that wherever you have monitoring controls, you need to have an alert and action limit along with the specification limit.

@venkatalaxmi6778 3 жыл бұрын

Why URS was placed after risk assessment. URS should be before the change control itself or not?

@hitendrakumarshah3718 3 жыл бұрын

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.

@wasimiqbal9422 3 жыл бұрын

If their is 2 DI plant for purified watet...on laternate basis its operates... Validation will be done seperate or can be combined...

@hitendrakumarshah3718 3 жыл бұрын

You need to ensure performance of the both plants.

@wasimiqbal9422 3 жыл бұрын

Your presentation is very interesting and learning...thank u so much for great session

@hitendrakumarshah3718 3 жыл бұрын

Welcome. Keep Learning !!!

@muthinenishravankumar3581 3 жыл бұрын

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.

@hitendrakumarshah3718 3 жыл бұрын

Yes. After modification, complete validation is required. Please refer again the recorded webinar for details. Same is discussed duirng Q&A session.

@Bharatpithiyalive Жыл бұрын

Sir please share draft guidelines

@hitendrakumarshah3718 11 ай бұрын

Which draft guideline you are looking for. Please clarify. i will share link to access the guideline

@Bharatpithiyalive 11 ай бұрын

@@hitendrakumarshah3718 Required process validation protocol and who gmp guidelines

@wasimiqbal9422 3 жыл бұрын

In distribution line purified water temperature is 70 C maintained...in presentation not discussed this point..kindly confirm that its mandatory requiremwnt...

@hitendrakumarshah3718 3 жыл бұрын

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....

@Krishna-nn2yr 3 жыл бұрын

Sir please correct in slide Average + 2 Sigma is alert limit and average + 3 Sigma is Action limit

@hitendrakumarshah3718 3 жыл бұрын

Correct. Its an error. Thank you for kind comment.

@muthinenishravankumar3581 3 жыл бұрын

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?

@hitendrakumarshah3718 3 жыл бұрын

Yes. Sanitation of generation system is required. The fowling smell is due to microbial load. You have reduce the load at generation step also.

@Vishalchaurasiabpharm 3 жыл бұрын

Yes

@Vishalchaurasiabpharm 3 жыл бұрын

During phase 2 study, we can increase sampling point

@hitendrakumarshah3718 3 жыл бұрын

No. During Phase 1 and Phase 2, the sampling point and frequency remains same.

@anilpradhan3978 3 жыл бұрын

Sir types & usage of water system not visible properly. Please send it.

@hitendrakumarshah3718 3 жыл бұрын

You can refer the recorded webinar by following the same link.

@wasimiqbal9422 3 жыл бұрын

Periodic revalidation on frequency based is required or not? One time activity is enough and routine monitoring will be done kindly clear plzzz...

@hitendrakumarshah3718 3 жыл бұрын

Yes. We need to reevaluate the water system periodically.

@wasimiqbal9422 3 жыл бұрын

3 phases will be repeat ? Accordingly for perioidic validation

@hitendrakumarshah3718 3 жыл бұрын

Wasim Iqbal Not required. You need to re-evaluate the system. That’s it

@baprasadraobanda9031 3 жыл бұрын

I need one question why yu are performed BET Purified water? Pls sent answer..

@hitendrakumarshah3718 3 жыл бұрын

NO. BET and Sterility test is not applicable for purified water. Also, I dont recommend to perform for purified water.

@mkjha4897 3 жыл бұрын

yes

@hitendrakumarshah3718 3 жыл бұрын

Thanks for confirmation !!!

@muthinenishravankumar3581 3 жыл бұрын

How to address the gaps among the validation phases(immediate after completion, next phase has not started).

@hitendrakumarshah3718 3 жыл бұрын

Sorry.. Not clear with your question.

@muthinenishravankumar3581 3 жыл бұрын

@@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.

@hitendrakumarshah3718 3 жыл бұрын

@@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.

@danapaaniwithakki5987 3 жыл бұрын

@@muthinenishravankumar3581 for easy understanding in Hindi I will suggest you Pharma scholars

@anilpradhan3978 3 жыл бұрын

Sir if we planned to buy a new equipment. i.e. blister packing machine. Do we need a change control for this?

@hitendrakumarshah3718 3 жыл бұрын

Yes. Ofcourse !!!

@anilpradhan3978 3 жыл бұрын

Thank you Sir

@hitendrakumarshah3718 3 жыл бұрын

anil pradhan welcome. Keep learning!!!

@aryanpant982 3 жыл бұрын

a big fan sir...

@hitendrakumarshah3718 3 жыл бұрын

Thank you so much for your comment. Please keep learning !!!

@Vishalchaurasiabpharm 3 жыл бұрын

Alert and action limit is different of each sampling

@hitendrakumarshah3718 3 жыл бұрын

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.

@rajugopale4651 3 жыл бұрын

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?

@hitendrakumarshah3718 3 жыл бұрын

Yes. We need to perform complete sanitation and followed by complete validation.

@Vishalchaurasiabpharm 3 жыл бұрын

Its only required 7 days study i.e. requalification and not need for phase 3 study

@samvdio7513 3 жыл бұрын

Dear Hitendra sir looking for your guidance

@hitendrakumarshah3718 3 жыл бұрын

Sure...

@wasimiqbal9422 3 жыл бұрын

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

@hitendrakumarshah3718 3 жыл бұрын

Not clear. Whether you have only online TOC? Or even you dont have any TOC? Please provide clarity

@wasimiqbal9422 3 жыл бұрын

We havent online TOC installed..in purified water plant

@wasimiqbal9422 3 жыл бұрын

Although in QC lab Offline TOC also out of order...we can test oxidizable substance as per BP specs

@hitendrakumarshah3718 3 жыл бұрын

Wasim Iqbal No

@hitendrakumarshah3718 3 жыл бұрын

Wasim Iqbal ok. I suggest you need to have online TOC

@Vishalchaurasiabpharm 3 жыл бұрын

Source of water change then what is require

@hitendrakumarshah3718 3 жыл бұрын

You need to re-qualify existing system.

@lokeshkota1476 3 жыл бұрын

What is meant by dead legs

@hitendrakumarshah3718 3 жыл бұрын

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.

@muthinenishravankumar3581 3 жыл бұрын

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.

@priyadarshikumar2754 11 күн бұрын

@samvdio7513 3 жыл бұрын

Pls tell me any reference guidelines available for clean and unclean hold period of equipment and accessories used for manufactring of OSD formulation.

@hitendrakumarshah3718 3 жыл бұрын