Evaluation of Accuracy and Precision According to the new ICH Q2(R2) - Consideration of Uncertainty
Joachim Ermer Overview:
Validation of analytical procedures, i.e. the demonstration of suitability for the intended purpose is an essential GMP and regulatory requirement. The just published revision of the ICH guideline Q2(R2) “Analytical procedure validation” provides recommendations to address the relevant performance characteristics, for example accuracy and precision. A new aspect included in the revision is the consideration of uncertainty in the assessment by means of confidence or other statistical intervals which are to be compared to the acceptance limits.
Why you should Attend:
A rational, efficient, and science-based validation is important to ensure an appropriate performance of analytical procedures as well as to obtain a marketing authorization of a pharmaceutical product. Therefore, a comprehensive understanding of the performance parameters and is key. Participants will learn in this webinar about the possibilities to calculate uncertainties for precision and accuracy, in order to better understand the challenges, and thus to avoid pitfalls and be prepared for future regulatory expectations.
Areas Covered in the Session:
- Precision levels (system precision, repeatability, intermediate precision, reproducibility)
- Calculation of the precision levels by analysis of variances
- Uncertainty of precisions: point estimators and confidence intervals
- Accuracy: Comparison, recovery, and technology-inherent justification, combined evaluation of accuracy and precision
- Statistical evaluation (confidence, prediction, tolerance intervals)
- Implications and challenges for the design of experimental studies (number of replicates, series/runs)
Who Will Benefit:
- Analysts, lab supervisors and managers in Analytical Development and Quality Control responsible for method development, optimization, and validation.
- Quality Assurance and regulatory affairs representatives responsible to approve or evaluate analytical procedure validation
Speaker Profile
Dr. Joachim Ermer is a biochemist with 30 years of experience in pharmaceutical analytics, including development products at Hoechst AG, global responsibilities as Director of Analytical Processes and Technology at Aventis, and head of Quality Control and head of QC Lifecycle Management Frankfurt Chemistry at Sanofi. From 2010 till 2020, he was also responsible for the central reference standard group and Global Reference Standard Coordinator of Sanofi. Since December 2020, he serves as consultant for topics of pharmaceutical analytics and Quality Control. Joachim Ermer is member of the USP Expert Committee “Measurement and Data Quality“, of the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and Advisory Board member of the ECA Analytical Quality Control Group.
He authored more than 60 publications on analytical topics and contributed to the USP General Information Chapter <1220> as well as other Stimuli Articles. He is editor and author of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005, 2015, 2024).