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what is correlation between annual product quality review and
retrospective validation?
what is relation between the change control,change deviation
and non confirmatory report?
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Answer Posted / ranjana rawat
Annual product quality review APQR is generally a
comprehensive summery of all batches of a product
manufactured in a calender year. this summery contain all
the process parameters with the observed limits at different
stages of manufacturing as RM, IP & FP. the process
parameters and observed results are generally represented by
graphical representation. during the graphical
representation and compilation of APQR if any discrepancy
found we investigate about that discrepancy. this
investigation is known as retrospective validation. the
discrepancy may be of several types as of out of trend, out
of specification etc. to rectify all the discrepancy in
future batches is known as retrospective validation.
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