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. |