Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

- Assay controls within acceptance criteria or specification? - System suitability parameters within acceptance criteria?

Laboratory Investigation Conclusion: a./ Assignable Cause: Initial results invalid, repeat test, retain the initial data, but do not use b./ No Assignable Cause: Inconclusive, retest the sample

4. Equipment qualification

Detector response (UV, DAD, Fluorescence, EI, RI, ELSD, MS)

Verify detector response/linearity with at least 3 concentrations of analytical standard or certified reference standard if available. Concentrations should include the low, high and the mid-range of the calibration curve. Pump flow accuracy and precision, column temperature accuracy and stability, wavelength accuracy, signal-noise and drift, injection precision, injection carry-over, gradient composition accuracy, gradient composition noise and drift, sample temperature accuracy

At least once with each batch

Chromatographic Systems (GC, IC, LC)

Annually, or after maintenance and repair

08/09/2018