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Hi all,
happy to share this incident .
Topic is HPLC Calibration:
While running Calibration of LC wavelength accuracy has been failed at minimal absorbance with caffeine.We found that it happen because of out let ball valve of pump in Agilent 1260 infinity model.
My user raised the breakdown request to service engineer as "Wavelength accuracy failed".
At the same time we addressed the same through incident.
Service engineer replaced the out let ball valve with new one .And carried out the calibration by doing Flow test as it required for any ball valve changing.
1.What is the CAPA?
2.Is prevention is required where we proposed only corrective action?
3. Is it required to reanalyze the previously approved batches on same system, and our SOP says to reanalyze three batches on other instrument.
4.0 Any root to not analyse those three batches?
Regards
SATYA
happy to share this incident .
Topic is HPLC Calibration:
While running Calibration of LC wavelength accuracy has been failed at minimal absorbance with caffeine.We found that it happen because of out let ball valve of pump in Agilent 1260 infinity model.
My user raised the breakdown request to service engineer as "Wavelength accuracy failed".
At the same time we addressed the same through incident.
Service engineer replaced the out let ball valve with new one .And carried out the calibration by doing Flow test as it required for any ball valve changing.
1.What is the CAPA?
2.Is prevention is required where we proposed only corrective action?
3. Is it required to reanalyze the previously approved batches on same system, and our SOP says to reanalyze three batches on other instrument.
4.0 Any root to not analyse those three batches?
Regards
SATYA