By Margaret Maziarz, Paul Rainville, and Sherri Naughton, Waters Corporation
Analytical procedures (methods) are a critical element of the overall quality control to ensure the identity, quality, purity, and efficacy of drug substances and drug products. A method that is used for quality testing of the manufactured product must be validated to demonstrate it is suitable for its intended purpose by meeting the proper standard of accuracy, sensitivity, specificity, and reproducibility. After implementation in a QC laboratory, a validated method should be monitored during its lifecycle to continually assure that it remains fit for its intended purpose.
Continued performance verification of the analytical procedure lifecycle approach routinely examines performance data of a method over its lifecycle. Therefore, large amounts of data must be reviewed to confirm that the method continuously meets the performance goals. This white paper describes the use of Empower™ 3 Control Charts to facilitate the continued procedure performance verification stage of the analytical procedure lifecycle approach. Control charts from the Empower 3 Software provide graphical representation of the performance characteristics data trends over time. They provide an easy way to perform trend analysis of data generated by a method, which allows quick identification of any out-of-trend results or deviations from the performance goals. This helps to predict any potential performance problems or take preventive and corrective actions before a major problem occurs.