Sarah Thompson

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Paulista/stock.adobe.com – For high-risk analytical procedures, control-chart monitoring of selected performance data can provide early warning of changes in performance.

Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>

Phil Borman;Amanda Guiraldelli Mahr;Jane Weitzel;Sarah Thompson;Joachim Ermer;Stephanie Sproule;Jean-Marc Roussel;Jaime Marach;Horacio Pappa
March 2nd 2023

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Sarah Thompson;Nancy Lewen;Graham Cook;Andrew Teasdale;Katherine Ulman;Lance Smallshaw;Carlos W. Lee;Helmut Rockstroh;John Glennon;Samuel Powell;Cyrille C. Chéry;Laura Rutter;Laurence Harris;Vicki Woodward
March 2nd 2015

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

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