Kombucha ERP

Kombucha Method Re-submission Review Form

Submission Date

2018-11-19 18:48:45

Name

SNEH BHANDARI

Email

sneh.bhandari@mxns.com

Organization

Silliker Laboratories

Candidate Method Number:

KOM-04

Has the resubmitted method met the requirements outlined on September 24, 2017? Please provide justification for your answer. If specific requirements were made in the September 24 meeting, please explain how those requirements have been met or not met.

No

-LOD and LOQ determined based on repeated injection of diluted calibration 0.05%. This approach captures variation of the injection but not of the process of the calibration and variation caused by independent calibrations. The approach not verified on Kombucha samples. -Precision of the method calculated based on repeating 3x injections of BCR- 652. This is precision of the injection not the analysis of ethanol in Kombucha samples. -Multiple definitions are lacking. -Accuracy data provided based on BCR-652 analysis not clear, number of replicates not clear (no precision value provided), very limited data available. -The method precision data on Kombucha samples lacking and not available. -Spike recovery data presented are incomplete and necessary in formation lacking. -The method performance does not meet SMPR.