Continuous verification of performance of analytical procedures using Empower Chromatography Data Software check charts

By Margaret Maziarz, Paul Rainville and Sherri Naughton, Waters Corporation

Analytical procedures (methods) are an essential part of overall quality control to ensure the identity, quality, purity and efficacy of drug substances and pharmaceutical products. A method used to test the quality of the manufactured product must be validated to demonstrate that it is fit for its intended use by meeting the appropriate standard of accuracy, sensitivity, specificity and reproducibility. After implementation in a QC lab, a validated method must be monitored throughout its lifecycle to continually ensure that it remains fit for its intended purpose.

Continuous Performance Verification of the Analytical Procedure Life Cycle Approach regularly examines a method’s performance data throughout its life cycle. Therefore, large amounts of data must be reviewed to confirm that the method consistently meets performance goals. This white paper describes the use of Empower™ 3 control charts to facilitate the continuous procedure performance verification step of the analytical procedure lifecycle approach. Empower 3 software control charts provide a graphical representation of performance characteristic data trends over time. They provide an easy way to perform trend analysis of method-generated data, allowing quick identification of any off-trend results or deviations from performance targets. This helps predict any potential performance issues or take preventative and corrective action before a major problem occurs.

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