Product Quality Review (PQR) Key Questions and Answers
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- čas přidán 31. 10. 2023
- #pqr #pharmaceutical #pharma #fda
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During this session, three questions below are discussed in line with guideline expectations -
1. Do we need to perform the statistical process control evaluation during the Product Quality Review?
2. During trending for product Quality Review, is it required to include results gathered from the previous period?
3. Is it required for the responsible official of the site to sign on the Product Quality Review?
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great topic
Thanks
If UCL and LCL are out side from the specification during normal analysis, then how the control limit will be determined for implementation ?
How you calulate UCL and LCL? You need to evaluate the trend
Thank you Sir, your webinar help me a lot. I have some quations about PQR ;
1. Can review period for PQR less than 12 month ?
2. should we perform capability analysis for all critical quality attributes (CQA)
3. What the different between OPV and PQR ?
Thank you sir
1. The review period should be annually only. However, you can have quarterly of half-yearly evaluations.
2. We need to perform capability for the most possible parameters - CQA as well as CPP.
3. The CPV and PQR are totally different. For CPV, I will be conducting two days complete seminar. You can go through the link for details
Link - czcams.com/users/postUgkx4PtNW4v2XmF7-EhEZ78WnYkNnM_WmVxQ
Is cpk calculation is required for sustain release product incase of dissolution test.
I suggest Yes.
Which para meter should we calculate cpk value.??
The quantitative parameters
Which should we follow to know the updation of guidelines
Your Question is not clear. Do you mean that, how anyone will come to know whether the gudieline is updated or not? If this is your question, I suggest to refer the website of the authority. For example, for EU, you can refer Eudralex, EMA and then from them you need to download it. Similar way you can download from FDA, PIC/S and other ...
Good evening all of you!!!
If CPK is below 1 , shall we stop to manufacture the batch whether all batch results was well within limit.
No. Not actually stop. But, yes, we need to immediately investigate the reason for less CPK. and take action so that, in next cases, it will be more than 1.33 or above(The limit as per CPK)
In PQR how we justify that which tool is useful for less number of batches and large number of batches?
You should able to evaluate the data. You can choose any suitable tool
Hello Sir ,
Could you please help me in issuing of product quality review report ; i am asking about details of machine&equipment calibration / qualification dates ,
1_ shall it be documented again in the PQR report ? Or it is enough to state that annuals plans and trackers are reviewed and i found that no deviations in it ?
2_ is it right to issue PQR for some products registered in WHO PQ ; and issue APR for others following only the local authority ; if this process described in SOP ? Or it is a deviation ?
1. It should be documented again and reviewed. In case of any error/s in annaul plans or trackers, the errors can be rectified and ensured.
2. Your question is not clear. PQR needs to be prepared for all products. You can do the bracketing. It is acceptable as per the guideline.
Please Conduct one session on media fill discussion
Sure
If cpk value is below 1, and results are with in limit how to investigate and assign CAPA
If CPK is less than 1, you need to evaluate, due to which batch, results are below 1 and then investiate that batch.
CpK is minimal SPC in data analysis.. Upon you get the CpK less than 1 need to check the normality of the data through descriptive statistics and understand the skewness and kurtosis, Paratoo chart, histogram This will help to understand nature of the data to draw conclusions. From the data pick which are above the 80% consider for investigations taking into Factors such as In put RM quality, INP, CPP, Quality Parameters of the Upstream process. `If more than 80% of the batches are problematic then need to revise the limit in upstream process or relook the process to control it if it is impact on Final product CQA.
Management can review through MRM meeting
what is the question
what is the question