Contents

Analytical Requirements for Volatile (Gas Chromatography/Mass Spectrometry) 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, quality control sample, blank, and standard See Organic Quality Control exhibit Reanalyze or re-prepare as appropriate.
Qualitative identification Each sample Compare to spectra generated and retention times Report any unusual circumstances in narrative.
Quantitation Each sample. See also Section 6.0 for surrogate and internal standard. Calculate off continuing calibration Report any unusual circumstances in narrative.