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FDA Warning Letter: Outlier Test inadequate for OOS InvestigationThe handling of deviations, i.e. Out of Specification (OOS), Out of Limit (OOL), Out of Trend or atypical test results is unfortunately insufficiently described from a regulatory point of view. The only existing FDA guideline does not refer to microbiological issues. For this reason, the ECA's Pharmaceutical Microbiology Working Group decided two years ago to produce a supporting document that provides guidance on how to deal with such microbiological deviations based on the experience of its members and regulatory expectations. The first chapter entitled "Guidance for deviation handling of microbiological environmental monitoring excursions in non-sterile pharmaceutical manufacturing" was published in 2018. Now the Group announced the second section "Endotoxin Testing Lab Investigations - OUT OF SPECIFICATION (OOS)/OUT OF TREND (OOT)/ATYPICAL RESULTS INVESTIGATIONS". This new chapter addressing - OOS/OOT/Atypic versus Invalid
- Define a OOS flowchart
- Organizational tools for conducting Investigations
- OOS investigation checklist
in a comprehensive presentation was written by Meghan Provenzano, Matthew Paquette, Jordi Iglesias and Alan Hoffmeister and reviewed and approved by the Advisory Board of the Working Group. This second chapter will be published on the occasion of the European Microbiology Conference 2020 on 06/07 May 2020 in Barcelona, Spain, where participants will have the opportunity to discuss this interesting topic with the authors and international experts.
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发表于 2021-7-25 11:53:45
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