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.