Equipment & Instrument Qualification

[@sudiphazra3956]

Dear sir , Thanks for providing good guidence regarding qualification .way of teaching with examples with using simple way that really helps me to understand study .i appreciate you sir .thanks a lot

[@hitendrakumarshah3718]

It's my pleasure

[@bhushanpdhangar1801]

Nice easily understand all topics Sir my question is If same Equipment which are already qualified they are transferred from Plant A to plant B then qualification is again required ??

[@hitendrakumarshah3718]

Yes. If you transfer the grouted equipments, you need to perform qualification again.

[@selenecalvo6769]

Very clear! Many thanks for sharing your experience ando knowledge!

[@hitendrakumarshah3718]

Thank you for your comment

[@jayachandrank1075]

I have printer attached to my manufacturing equipment for printing the manufacturing details from the SCADA / PLC . My question is 1. Do we need to have password control. If yes , how many levels ? In No ...why not required. 2. Do i need to do IQ , OQ and PQ ? 3. for PQ what parameters to be qualified? Appreciate your reply please.

[@hitendrakumarshah3718]

Password control is required for security of the access and data. Of course you need to do complete validation as it is GXP system. For PQ, I need to understand the equipment and automation controls in details.

[@sansraentertainment652]

Thanku sir Very informative with good examples and easily understandable.

[@hitendrakumarshah3718]

Thanks. Please keep learning !!!

[@manojsanapala9273]

Please make a video on QC softwares like lims nd empower implemention process in company environment

[@hitendrakumarshah3718]

Sure

[@wasimiqbal9422]

In PQ placebo batch is mandatory or covered through process validation like example in compression machine

[@hitendrakumarshah3718]

You can take placebo batch. the only thing is ,you have to design the acceptance criteria for that placebo batch. Otherwise you can club with PV so that, already for PV batch, acceptance criteria is established.

[@shashishekhar4090]

Dear sir Is water bath comes under type A or type B instruments

[@hitendrakumarshah3718]

A

[@shashishekhar4090]

Thank you sir

[@sravankumar6844]

Hi Hitendrakumar Shah. I understood the concept. Is it possible for you to share SOP on Equipment Qualification, IQ, OP and PQ templates? Please neglect it if you don't. Thanks in Advance.

[@sravankumar6844]

Or maybe I can take a day or two class (online one-to-one) for practical implementation of above said docs. please suggest. Thanks

[@hitendrakumarshah3718]

Thanks for your kind comment

[@hitendrakumarshah3718]

Sure. Will arrange the same

[@AmitSingh-fk9fc]

Can we perform equipment performance qualifications of new facility without doing process validation on routine commercial batches.

[@hitendrakumarshah3718]

If it is new facility, you have to do process validation on commercial batches. You can have separate PQ no problem. But it is practically feasible to club both.

[@janmejaypatel9915]

Nice presentation Can I do preventive maintenance of any equipment after completion of batch?? Cleaning would be performed after completion of preventive maintenance. is it acceptable?

[@hitendrakumarshah3718]

I suggest, preventive maintenance should be performed after cleaning of equipment so as to avoid accumulation or entrapment of previous product residue in side the machine. Also, the persons safety is also important.

[@janmejaypatel9915]

Hitendrakumar Shah Thank you sir but technically can I oppose the engineering person? Because they will clean the machine after completion of the preventive maintenance

[@hitendrakumarshah3718]

@@janmejaypatel9915 I suggest please elaborate in detail. Need to have your main concern. Thank you

[@harisabdurrahman8254]

Is it okay to use a commercial scale batch for PQ ?

[@hitendrakumarshah3718]

Yes

[@prakashkarnatak8245]

Dear sir please tell with an example how to take change control before urs it is mandatory to take change control new equpment instrument despite area is validated

[@hitendrakumarshah3718]

Change control is no where related to area or other aspects. You can raise change control for new equipment and in this change control, you can evaluate the impact assessment and action items like area validation, URS.....all other things. Hope, it is clear to you. further if you have any question please feel free to put in comment section.

[@ravindrareddy570]

@@hitendrakumarshah3718 respected sir ,pls tell me the clear flow for equipment qualification briefly in comment

[@pabitrakumarpanigrahi]

In case of Hplc, OQ can be considered as complete calibration of Hplc ?

[@hitendrakumarshah3718]

calibration is for PQ. OQ means challenging the controls

[@NurIslam-nr6re]

Dear sir, I am one of your followers and I also watch regularly your KZbin lecture. in this video ''Equipment & Instrument Qualification'' you mentioned "'Equipment qualification can be done along with process validation. Where a separate protocol for qualification and validation is required". We are doing our qualification activity in this way. But my quality team always enforce me to conduct the qualification using a placebo batch. I want to know the Guideline reference. It would be very helpful to me if you provide me with the reference guideline.

[@hitendrakumarshah3718]

I personally suggest performing PQ on the product where you have established specifications. If we perform on placebo, it will not have specifications. Secondly, you can refer EU annex for these details.

[@maulikparmar1448]

Hello sir. First of thank you very much for sharing such wonderful knowledge with us. It is very helpful for us to know the current regulatory requirements with compliance. Sir I have one question about equipment qualification. For performance qualification of new capsule filling machine one dummy batch is enough or we should perform PQ on 3 dummy batches. Thanks in advance.

[@hitendrakumarshah3718]

I would like to tell you that, performance will be achieved if we get consistent results. By one batch we will not get idea about performance. If you want to do PQ on placebo, acceptance criteria should be clear.

[@anbazaganchinnappanshe8664]

⁰

[@srinivasreddygovindapur733]

Which guide line section is refer to this topic

[@hitendrakumarshah3718]

This session is on the basis of many regulatory guidelines. During discussion also, I referred....

[@preetisandeepshukla6547]

Nice presentation sir, I have one question, if in any equipment our PLC is modified then Only PLC is validated or our equipment also to be requalify?

[@hitendrakumarshah3718]

You need to validate PLC only. No need to validate equipment. But yes, you have to check and evaluate the parameters of equipment which are impacted by PLC by performing PLC validation. I suggest, Quality Risk Management tool can help you to for this.

[@preetisandeepshukla6547]

Thank u sir

[@hitendrakumarshah3718]

Preeti Sandeep Shukla welcome. Keep learning

[@krishnakishore6517]

When to initiate PO , I mean before DQ or after DQ

[@hitendrakumarshah3718]

PO should be initiated before DQ.

[@samvdio7513]

Sir thanks for such good session which always helpful. My question is In Performance Qualification if we take commercial batch what will be release criteria for batch into market?

[@hitendrakumarshah3718]

If you take commercial batch for PQ, the release criteria will be same what you have for Process validation batches.

[@Kumaraswamy99126]

Very nice it will be every body understood we need separate session for risk assessment

[@wasimiqbal9422]

Sir my request if session will introduce related to preparation of protocol and execution and report writing through one example

[@hitendrakumarshah3718]

I agree with you. This topic requires minimum 2 days for complete understanding with practical implementation approach. If you and some of your team mates are interested with detailed 2 days session, confirm.

[@ulhasdesale9181]

How many batches need to be studied during performance qualification?

[@hitendrakumarshah3718]

Min 3 batches.

[@playlistajsy4486]

What would be the frequency to prepare VMR.

[@hitendrakumarshah3718]

I suggest - yearly

[@wasimiqbal9422]

Product development equipment also covered in qualification?

[@hitendrakumarshah3718]

Yes. Equiment qualification should be performed for product development equipment also.

[@niravshah8605]

Good example 👍👍

[@hitendrakumarshah3718]

Thanks! 😃

[@bubundatta4911]

Excellent sir....

[@hitendrakumarshah3718]

Thanks. Please share this link with your colleagus so that, they can also get benefit from the video learning.

[@bubundatta4911]

@@hitendrakumarshah3718 sure sir

[@jayachandrank1075]

What is the difference between PLC / SCADA and HMI. Please help explain

[@hitendrakumarshah3718]

HMI - Human Machine Interface PLC- Progammable logic controller SCADA - Supervisory control and data acquisition.

[@baskar-gz6hq]

At new manufacturing facility what is the criteria For area requalification ?

[@hitendrakumarshah3718]

For new facility, it will be qualification and not requalification.

[@baskar-gz6hq]

@@hitendrakumarshah3718 sir new plant first qualified manufacturing process going on then now what is the criteria for requalification ?

[@drx.kalpeshgayakwad6094]

Dear sir can you please guide me What is actually impact plese suggest me If batch size taken below blender capacity or above blender for mixing it is impact ing on sampling or mixing Please tell me the refrence guidline Theoretically I know but I can't justify without proof or guidelines reference

[@hitendrakumarshah3718]

I was having one literature. Let me search. Will definitely share you once i got it.

[@swapnilpuranik5477]

Sir Before coming the instrument new risk assessment

[@hitendrakumarshah3718]

Yes

[@srinivasreddygovindapur733]

Sir my request is add the each and every guide lines section of each your explain topics

[@srinivasreddygovindapur733]

Each topic related which guide in 21 cfr

[@hitendrakumarshah3718]

Many places where guideline ref is given. The guideline logo is put on the slide while discussion.

[@hitendrakumarshah3718]

Many places where guideline ref is given. The guideline logo is put on the slide while discussion.

[@moumitaadhikary8847]

India.

[@hitendrakumarshah3718]

Yes

[@arunkurhade1307]

Very informative session and practical oriented, kindly ICH Q12 Life cycle management and Quality by Design (QBD)

[@arunkurhade1307]

Can take session for above mentioned topic

[@hitendrakumarshah3718]

Sure. will definitely consider these subjects

[@hitendrakumarshah3718]

Sure. Thank you for suggesting the topics.

[@pradeepjonnalagadda4682]

Thank u sir such a wonderful session given with us we learn more and more from this flatform once again thank u

[@hitendrakumarshah3718]

Welcome!!! Please keep learning...

[@solution24x50]

Dear Sir, What is the difference between PQ and PV

[@hitendrakumarshah3718]

I have explained in the training session in detailed. PQ is done to prove the equipment performance while PV is done to prove process. Please refer the video training again. After that, still if you have question, please elaborate your question in more detail.

[@wasimiqbal9422]

Periodic qualification can be after 03 years?

[@hitendrakumarshah3718]

No problem. Only you need to have rationale why 3 years? Not 2 years or 5 years.

[@bobby0058]

Who has to carried out DQ... Vendor or user.... During DQ which documents to be referred

[@hitendrakumarshah3718]

DQ should ensure that the designed equipment, if built, will satisfy all the detailed specified requirements. It should be carried out by qualified people who can challenge the design performance. If it is done by vendor, still user need to evaluate whether it will meet user requirements or not?

[@bobby0058]

Thank u sir

[@hitendrakumarshah3718]

@@bobby0058 Thank you. Keep Learning !!!

[@santoshparida9766]

What is comissioning??

[@hitendrakumarshah3718]

Comissioning in simple language construction

[@venkateshch-yi2xg]

sir we are discussing about quality ,validation and qualification but your voice not syncing with video , there no quality , i have interest on u r videos but when seeing time i am loosing my interest because of there no synk with video

[@hitendrakumarshah3718]

There may be posssibility of problem due to netwok fluctuation during the actual training session. I suggest, you should join online training organised on every saturday at 20:00 Hrs so that you will not loose the interest.

[@wasimiqbal9422]

If possible

[@hitendrakumarshah3718]

Please elaborate your question.

[@sachinkokil2859]

Yo sir

[@sachinkokil2859]

Hi

[@hitendrakumarshah3718]

Hello

[@mohitkumar7447]

Movie bany hain ya you tube video 🧐

[@hitendrakumarshah3718]

It is for learning purpose and not for entertainment.

[@sangamkalyani536]

Sound not clear

[@hitendrakumarshah3718]

OK

[@sharadsanghvi9228]

Vidio is very poor, may lesssion is good but can’t understand what u want to say, pl , check , in your mobile link how it is !!!!!!???

[@hitendrakumarshah3718]

I checked. It is working good. Yes, some places there is echo sound. Actually, this was online session which was recorded.

[@hitendrakumarshah3718]

Good Evening!!!

[@riyanab2079]

🤦‍♀️

[@hitendrakumarshah3718]

🙏🏻