Contents

Analytical Requirements for Semivolatile (Gas Chromatography/MassSpectrometry) Quality Control

Effective Date: 11/01
Point of Contact: Quality Engineer for Regulatory Programs

Quality Control Requirements Frequency Criteria Failure Action
Tune Once on a 12-hour clock See Minimum Calibration Requirements for Gas Chromatograph/Mass Spectrometer System exhibit. Investigate. Correct.
Continuing Calibration Verification Once on a 12-hour clock See Organic Quality Control exhibit Investigate. Correct. Reanalyze.
Internal standard Each sample, QC sample, blank, and standard See Organic Quality Control exhibit Investigate. Correct and reanalyze or re-prepare.
Qualitative identification Each sample Compare to spectra generated and retention times Report any unusual circumstances in narrative.
Quantitation Each sample. See also Calibration Requirements for Organic Analyses for surrogate and internal standard. Calculate off continuing calibration Report any unusual circumstances in narrative.