Evaluation of Accuracy and Precision according to the new ICH Q2(R2)

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