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Validation of analytical methods involved in dissolution assays: acceptance limits and decision methodologies.
E Rozet1, E Ziemons, R D Marini
1Analytical Chemistry Laboratory, CIRM, Institute of Pharmacy, University of Liège, Liège, Belgium. Eric.Rozet@ulg.ac.be
Analytica Chimica Acta
|October 23, 2012
Summary
Analytical method validation ensures dissolution testing accuracy for consistent product quality. This study addresses how to determine method validity and set acceptance limits, aligning with Quality by Design principles.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
Background:
- Dissolution testing is crucial for ensuring consistent pharmaceutical product quality and performance.
- Analytical method validation is essential to confirm that methods accurately assess dissolution profiles and pharmacopoeial compliance.
Purpose of the Study:
- To address the lack of guidance in ICHQ2 on determining analytical method validity for dissolution testing.
- To establish criteria for deciding method validity and setting appropriate acceptance limits.
- To align method validation with Quality by Design (QbD) principles and define the Analytical Target Profile (ATP).
Main Methods:
- Focus on Quality by Design (QbD) principles for defining the Analytical Target Profile (ATP).
- Investigating the necessary validation criteria and acceptance limits for dissolution testing methods.
- Evaluating the decision-making process for analytical method validity.
Main Results:
- The study aims to answer critical questions regarding the extent of validation criteria needed for Quality Control (QC) dissolution methods.
- It seeks to define how to set acceptance limits and make decisions about method validity.
- It proposes a framework for method validation that moves beyond a simple checklist approach.
Conclusions:
- Analytical method validation should demonstrate fitness for purpose, ensuring reliable dissolution testing.
- Adopting QbD principles allows for a more rational approach to defining ATP and validating methods.
- This work advocates for a purposeful validation strategy over a compliance-driven checklist, enhancing pharmaceutical quality control.
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