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Answer Posted / natraj kumar
Example HPLC calibration : - Suppose one parameter is
failed .keep the status board for Instrument breakdown.And
raise the OOC (Out of calibration )document take the
approval from QC and QA Head. After rectification or change
the part of the Instrument, check the failed parameter of
calibration.
If it is Passed, then check randomly impact assesment of
the previous analysis during this calibration period.If
there is no impact then u can proceed for regular
usage.Total process to be complete in 30 days only.
OOC document keep the calibration file. Service report is
also keep the filing internal or External service person.
Dr.Reddys Lab
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