Bioequivalence and Bioavailability Forum

Dear Ramesh,

You can reintegrate any chromatogram that was not properly integrated by the initial automatic integration, whether CC, QC or subject sample. But the reason should not just be that the CC or QCs are failing...

Remember that reintegration of the chromatograms is one of the first things any inspector will check when inspecting a trial at your site, whatever the country the inspector comes from. And if the inspector thinks that you changed chromatogram integrations to be able to validate a failing run (whether this is true or not) that's the end of your trial, and the beginning of problems.

I would recommend you to keep a printout of the chromatogram before and after re-integration (that's a basic GLP requirement anyway) and to properly document what you are doing and why. Make sure that the integration is done consistently with similar chromatograms of CCs, QCs and subject samples. This will avoid you lots of problems and discussions.

Regards
Ohlbe

Dear Ramesh

Manual integration is always there, so the first thing to do is to set your procedure and stat why do you need re-integration,...

Write SOP for Re-Integration.

for the worst case senario, if you needed to re-integrate the whole set, at least be consistant with your approach on how you are integrsting,
e.g, if there where a tailing peak, and no chance to repeat analysis and you need the data, do the re-integration systematically, not integrating with tail, and the other run you exclude the area of tailing.

regards
Charl

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Edit: Capitals formated in bold. [HS]