Product Quality Review (PQR)

This training will help you to understand about regulatory requirements for annual product quality review(PQR). Further emphasis will be given to make you understand on different requirements by different regulatory agencies (FDA,EU,WHO,TGA etc.). The discussion will be focussed on expectations by agencies along with practical implementation approach. The attendee will learn from this training on making use of statistical tools while preparing the PQR. Further, the common non conformance related to PQR shall be discussed. At the end of this session, the questions raised by the participants shall be answered.
AA. Vedic Gyan. KD,PHARMA PORTAL,Prof.Karan Ajay Gupta,Pharma Pill,Vivekanand Education Society's College of Pharmacy,

[@topaz7421]

Hello Hitendrakumar, how do we confirm the supply chain traceabiility of the API? Also when listing all the starting materials used, what is the purpose of this?

[@hitendrakumarshah3718]

It is required for ensuring safety of the material and compliance to the guideline

[@neyaishalam3296]

Thanks lot for free study

[@hitendrakumarshah3718]

Welcome

[@kateganofrank365]

I would like to inquire, If I am given a question of say; data of in-process control tests (Diameter, Hardness, Thickness, Mass, Disintegration and Friability) and finished product results (Assay, Dissolution and Moisture) for five different batches.
If you are asked to evaluate and write a PQR report for the above data, what would you consider the most appropriate statistical tool to answer that question?
Note: The specifications are given.
Will Cp/ Cpkl /Cpku be the most appropriate tool?

[@hitendrakumarshah3718]

I suggest, you can go through the video on process capability.
th-cam.com/video/RTjQxWjeNaI/w-d-xo.html

[@lilaciris5972]

Sir, how can we determine the PQR periode review if our company have more than 90 product? If the timeline we used for pqr jan - dec , we cant complete all the pqr report in march. Thank you sir.

[@hitendrakumarshah3718]

You need to prepare it annually. The period for each product can be staggered. So that, all 90 products can be in one year. Means every month 7-8 only.

[@lilaciris5972]

​@@hitendrakumarshah3718Thank you sir. After we create a rolling calendar for APR , Can we determine when the month the product will be reviewed according to pareto or birthday of the product?

[@janmejaypatel9915]

Hello sir for the calculation of CPk should we include OOS result of any particular parameter or we should omit and then calculate CPK

[@hitendrakumarshah3718]

You have to consider all results which are used to release the batch.

[@janmejaypatel9915]

Hitendrakumar Shah In case OOS is found valid and batch is rejected then should we consider that data for calculation of CPK?
In case OOS is found invalid then which data to be considered for CPK calculation

[@bhimraogholap3635]

Hi sir, OOS, Deviation, it's statical evaluation consider or not, hence we consider then cpk less?

[@hitendrakumarshah3718]

You need to consider confirmed OOS, deviation. Let the CPK come less. Then you evaluate and record that, without the OOS/deviation batch, CPK is more. This will indicate that, the process is under control except some odd batches which were either rejected or manufactured with deviations. Hope this is clear.

[@janmejaypatel9915]

Hello sir would you please clarify like which type of contract details be included in APR??should it include the contract with API Vendors, service provider of qualification activity , third-party manufacturing, marketing authorisation contracts etc

[@hitendrakumarshah3718]

All the contractual arrangements should be considered.

[@tusharganage9814]

Quality Technical Technical agreements between API manufacturing site and Finished product Manufacturing site for API QTA. For FP agreement QTA between the your specific site and finished product manufacturing site

[@janmejaypatel9915]

Dear Sir should we calculate CPK for all CQA like dissolution Assay, related substance or should we calculate CPK for Assay only

[@hitendrakumarshah3718]

You have to consider for all CQA. Not only QC tests, but also you can have for average weight, hardness also. Please refer data distribution and all during end of the session for details.

[@supriiya4364]

Thankyou very much Sir🙏

[@hitendrakumarshah3718]

Welcome. Keep Learning !!!

[@sunilkumargnv8354]

Hi Sir Good evening,
If a firm is producing sfg (RTF ready to fill bulk)in one plant and FG (Filled unit ) in another plant, is it recommendable to prepare one PQR or is it required to prepare site specific PQR.
Please provide me guidance wrt to WHO guidelines .
Thanks in advance.

[@hitendrakumarshah3718]

The PQR should be site specific. As, equipment, utilities, system, procedures will be different. The regulatory agency may expect to see both PQR. Hence, the site who is finally filling and converting in final finished dosage form, should maintain the PQR of RTF facility. Hope, it is clar to you.

[@dhirajk2918]

Sir whats is diiff between pqr and Apqr

[@hitendrakumarshah3718]

Both are synonymous

[@devanggondaleeya4321]

Annual Product Review (APR) or Product Quality Review (PQR) on Time Rate =
the number of APRs or PQRs completed within 30 days of annual due date at the
establishment divided by the number of products produced at the establishment.
What is the meaning of this sir ?

[@hitendrakumarshah3718]

Your question is not clear.

[@maheshkamisetti3282]

Training session was marvellous sir.

[@hitendrakumarshah3718]

Thanks !!!

[@janmejaypatel9915]

Hello sir would you please clarify what exact data we should put in for supply chain traceability of API and Finished goods in PQR

[@hitendrakumarshah3718]

You have to perform the supply chain tracebility for API only. You will get details about this in our Q&A session of the same recorded webinar.

[@shaikhrahiltamboli1646]

sir Please clarify me which parameters i have calculated for CPK

[@hitendrakumarshah3718]

You have to consider for all CQA. Not only QC tests, but also you can have for average weight, hardness also. Please refer data distribution and all during end of the session for details.

[@abhijeetgaikwad4202]

Hello sir, would you please make one training video regarding IPQA.

[@hitendrakumarshah3718]

Yes. I am working on it. As, new roles of IPQA

[@naveenkumarsharma2234]

What is the supply chain traceability ? Kindly brief about it

[@hitendrakumarshah3718]

I suggest to go through the complete webinar in detail. You will get the answer. If you just follow PPT details, will not serve the learning purpose.

[@trinathponturu2841]

Hii sir Cp value devide by 6 why not 3?

[@hitendrakumarshah3718]

It is formula developed by statisticians.

[@abhijeetgaikwad4202]

Sir Awesome I understood properly

[@hitendrakumarshah3718]

Good. Keep Learning !!!

[@Nehadatyal]

Nice session sir .....

[@hitendrakumarshah3718]

Thank you for your kind comment. Please keep learning.

[@Nehadatyal]

@@hitendrakumarshah3718 hello sir I'm currently working in pharmaceutical company your session really helpful during audit exposure. Sir may I join you on LinkedIn.

[@hitendrakumarshah3718]

@@Nehadatyal Sure. You can send me invite.

[@Nehadatyal]

@@hitendrakumarshah3718 it's my pleasure sir

[@krishnagopaldixit5036]

Yes

[@hitendrakumarshah3718]

Thanks

[@AnandYadav-ko5bq]

Clear

[@hitendrakumarshah3718]

Thank you for your kind confirmation.

[@ayinileayinile9200]

Ok

[@hitendrakumarshah3718]

yes

[@ajjaiahkasandi8077]

Hello sir, would you please make one training video regarding IPQA.

[@hitendrakumarshah3718]

Sure. What you want in this video? Please share me contents. So that, I will prepare for you

[@oum2793]

@@hitendrakumarshah3718 hello sir, i can't find the difference between OOT and OOC (trend ; control) , and when to study each one of them??

[@komalgupta8536]

Yes

[@hitendrakumarshah3718]

Thanks

[@lakshmanatamada4176]

Yes

[@hitendrakumarshah3718]

Thank you

[@vaibhavpatil6393]

Yes

[@hitendrakumarshah3718]

Keep Learning !!!