3A: How to Demonstrate Fit for Purpose
- Start Date : 4 February, 2026
- Start Time : 1:45pm
- End Date : 4 February, 2026
- End Time : 3:00pm
- Address : Salon I, N Tower
No Schedule
Abstract
The USP is focusing on the metrological approaches based on Fit for Intended Purpose. This metrological approach is being used to ensure the laboratory test methods work so that our drugs, biologics, dietary supplements and food are safe and effective. One aspect of this concerns the instruments and equipment and ensuring they are qualified sufficiently. A new standard, USP General Chapter <1220> Analytical Procedure Lifecycle, explains how measurement uncertainty, target measurement uncertainty, and decision rules are used to quantitatively define how a test method needs to perform. This uses information from a clinical study through test method development to routine use in production of the drug. In addition, the USP General Chapter <1058> Instrument Qualification is being revised to incorporate the Fit for Intended Purpose approaches. These new general chapters will be presented with emphasis on how this impacts the people and companies attending the conference.
Jane Weitzel
Jane Weitzel has been working in analytical chemistry for over 40 years for pharmaceutical and mining companies. Recently she wrote the new chapter on Chemical and Biological Measurements and Uncertainties for The ASQ Metrology Handbook Third Edition. Her dedication now is to introduce, implement and use the metrological approach to measurements in the pharmaceutical industry. She was elected to the United States Pharmacopeia Council of Experts as chair of the 2020-2025 General Chapters–Measurement and Data Quality Expert Committee and is a member of the 2025-2030 EC Pharmaceutical Analysis Lifecycle and Data Science. She was a member of the USP 2015-2020 Statistics Expert Committee. She has been Director of pharmaceutical Quality Control laboratories. She has experience with many different regulatory environments. She is currently a consultant specializing in laboratory management systems, GMP testing, and ISO/IEC 17025. She is an auditor and an educator. Jane has applied Quality Systems and statistical techniques, including the evaluation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. Recently she is focusing on the implementation of the new USP General Chapter Analytical Procedures Life Cycle.