SOP – Handling of Extraneous Peak in Chromatography


This procedure is to be followed for to extraneous peaks observed during the chromatographic testing of pharmaceutical raw materials, in-process, finished products, and stability samples.

If the extraneous peaks are above the threshold defined in this procedure, an investigation shall be performed to determine the source and the identity of the peak(s).

This procedure is not applicable to method validation, method verification, method transfer activities, and analysis of non-GMP samples


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