Is Annual Product Review and Continuous process verification is same.? Is it mandatory for doing continuous process verification. As Annual product review is in place.
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No…CPV and APQR both are different…In APQR we mention only validation of that product annually and report notifications of that product annually but in CPV we Compare recent validation of that product with commericial batches by plotting control charts using Minitab so that we can know how commerical batches are showing trend deviation comparitive to validation batches. So that we can make necessary changes in our process and getting back our process in trend nd decreasing quality notifications.
Yes…Preparing CPV is mandatory…So that we can make our process Robust…
I would differ to say CPV is mandatory. No regulatory body says CPV is mandatory… it is in the initiative of the company to decide measures for continuous improvement. So it is upto the organisation to decide how and what CPV to implement.
Regards
Dear,
How we can get Minitab? through online or should be procured as certified!! and is it required to validate that software first?
Thanks