minimum how many batches are required for preparation of APQR and for how many batches we can apply 3sigma.
There should be sufficient data for trending minimum 10 batches.
Hi, how is this “10 batches” determined . Is this info in any guide. Would you recommend a guide that contains this info please. I can not find.
10 batches is generally considered for APQR-industry practice.
if the batches manufactured in the reporting period is less than 10. You can prepare APQR by clubbing the batches manufactured with last year batches manufactured (Grouped 10) or can prepare APQR of what ever batches manufactured which will be considered for trending and graphical representation.
For No of batches pls go as per SOP.
We know that there are many steps to manufacture a medicinal product. This means there is too much data in APQR. How can we calculate Cpk and Cp in the report?
You can sort out which are more critial process parameters and critical quality attributes, for other you can quoate the document reference number to avoid pile up data, as per your aspect and plot for 3sigma.
Sir is it necessary to maintain protocol or approved document format for the preparation of APQR, other protocols like process validation and cleaning validation
Genarally, there is an inhouse SOP prepared on how to conduct APQR and what elements are to be considered for quality review and its documentation; the formulae to calculate process capability etc. This SOP should be approved by QA Head.
There is no specific format for preparation of APQR. However, there can be a generic format prepared for APQR of all products. A detailed report of APQR for every product should be prepared as per SOP.
Generally summary report of APQR of every product is prepared and forwarded to the top management for their knowledge. as a part of Management Review. In some pharma companies APQR is presented by QA Head to the top Management every year highlighting the Quality issues.
ok got it, thank you for information sir.
one more question sir is there any software for the preparation of APQR. If THERE IS ANY SOFTWARE PLEASE TELL the name of the software.
SIR IS THERE ANY SOFTWARE FOR THE PREPARATION OF THE APQR. IF THERE IS ANY SOFTWARE PLEASE TELL ME THE NAME SIR.
I will keep you informed about the software of APQR preparation, if I come across.