Patrick Lukulay | Authors

Patrick Lukulay is Senior Principal Scientist in the Research Analytical group at Pfizer's Michigan Laboratories.


Automation of the Chromatographic Analytical Method Validation Process

This article describes a software solution for automating the chromatographic method validation process starting from experimental planning, data acquisition and processing, through final report generation in a seamless manner. All experimental planning and calculations are accomplished within the chromatography data software and, thus, are structurally validated, secure, and audit trailed. Highlights of the software are provided, including benefits to the analyst. The analysis of important method validation characteristics such as linearity, accuracy, and precision is automated. These characteristics and their acceptance criteria can be captured in a method template, which adheres to the company's standard operating procedure. This template method can then be used repeatedly by other scientists in the organization, hence, eliminating the need to create a new experimental plan each time a new validation is conducted.