Continued Process Verification

[@balvinderkumar5383]

Appreciate sir, and thank you Keep uploading informated and valuable videos...request to do on stratified sampling also...

[@hitendrakumarshah3718]

Sure. Will do it

[@masthangm4836]

Very comprehensively the subject is elaborated, thanking indeed. Can we not use the data collection from PQR to establish process stability as they are intra batch data? In spite of ongoing program. Please advise.

[@masthangm4836]

Because, all CQA and CPP data are collected to demonstrate the process stability.

[@masthangm4836]

​@@sarvilsanavBro! I have mentioned PQR which is Product Quality Review not PPQ! 😊

[@hitendrakumarshah3718]

The data from PQR can be used to evaluate process capabiilty and not process stability.

[@masthangm4836]

Thanks alot Sir! 👌👍

[@bongumusasithole1492]

Hi Sir, once you completed your CPV report and found that some CPPs or CQAs are below the Cpk/Ppk threshhold, how do you go about completing the Technical Evaluation?

[@hitendrakumarshah3718]

You can check why it is below? Is it due to specific batch data? Investigate in detail.

[@Bharatpithiyalive]

Sir... Kindly share link of FDA guidelines

[@hitendrakumarshah3718]

I have uploaded all relevant links in description section.

[@priyankadivakaruni9431]

Sir is there any point in guidelines that CpV report is prepared only if 10 batches are manufactured for a particular product in a review period.

[@hitendrakumarshah3718]

No. Number of batches is not specified.

[@sonikumar7269]

Thank u very much Sir ji for valuable information. I have question related to data point. As u suggested 20 data point. Please help for details information related 20 data points with example for better clarity.

[@hitendrakumarshah3718]

sure. You can refer the FDA stratified sampling guide for details. This guideline is not implemented but still provides good understanding.

[@prashantpandey668]

Need presentation

[@hitendrakumarshah3718]

Thank you for your kind comment