Quant. MAC Working Group Meeting Book (March 13, 2019)

November 2018: Conference Call

• As part of the follow up action items, it was determined to evaluate how frequent the s of the reference method is >0.125 (ISO criteria) • For PTM Validated Methods for total viable count, 38% of contamination levels evaluated

had a refence method with a s > 0.125 (182 out of 476 contamination levels).

February 2019 Conference Call • Updated WG on Action items from Annual Meeting • Proposed two action items, one short term and one long term Short Term Objective: • Establish a technical bulletin to provide expert reviewers guidance on evaluating methods • This document would allow for the continued evaluation of new quantitative technologies and provided consistency in the approach to data review. • The goal of this document would be to provide a consensus thinking on current acceptance criteria and accepting/rejecting methods.