Manual Integration - FDA/ICH Guidance Documents

[Scifi1]

Does anyone know if there are any FDA or ICH guidance documents on the subject of "Manual Integration"?

[DR]

I'm fairly certain that there are not. Integration has to be consistent and defensible. If it is covered by your SOPs, follow them. If you suspect that there are abuses via manual integration and there is no SOP covering this, maybe it's time to suggest one.

[JGK]

Certainly, in bioanalysis peak for FDA submission reintegration is permitted. However a full written justification is required in each case and the result has to be signed off by the lab manager.

This eliminates reintegration to tweak perceived low/high results or to obtain better replication.

I've even used mock exercises to assess the ability of staff to set integration markers on peaks to a similar standard before signing off on their ability to perform reintegration.

"Sample Data Reintegration: An SOP or guideline for sample data reintegration should be
established. This SOP or guideline should explain the reasons for reintegration and how the
reintegration is to be performed. The rationale for the reintegration should be clearly
described and documented. Original and reintegration data should be reported."

Taken from http://www.fda.gov/downloads/Drugs/.../ ... 070107.pdf However it could apply to any analysis no just bioanalytical