Jane Weitzel

Articles

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.

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

Amanda Guiraldelli;Jane Weitzel

December 20th 2022

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.

Evolution of Analytical Procedure Validation Concepts: Part I – Analytical Procedure Life Cycle and Compendial Approaches

Amanda Guiraldelli;Jane Weitzel

November 4th 2022

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.

The Value of Pharmacopeial Reference Standards

Christian Zeine;Doug Podolsky;Jane Weitzel;Ravi Reddy;Steven L. Walfish

February 3rd 2021

This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.