Rapid Method Development and Quality Regulatory Submissions – Combining UPLC, Quality-by-Design (QbD) and Software-Guided Validation
Method development and validation are essential parts of the pharmaceutical drug approval process. As process modifications are made and approval criteria become increasingly stringent, changes to the validated method are sometimes necessary. A Quality by Design (QbD) approach to method development uses statistical design of experiments (DoE) to generate a robust method ‘design space’. The design space defines a region in which changes to method parameters will not significantly affect the results, incorporating risk-based assessment of the final method. Rather than developing and validating a single method and proceeding through re-validation as modifications are made, a design space incorporates allowable flexibility into the method.
Mia Summers, Senior Business Development Manager, Waters Corporation
A QbD approach is demonstrated here in the development of a stability-indicating method, using UPLC for fast, sensitive separations, and software-driven validation. The flexibility of transferring methods between UPLC and HPLC will also be demonstrated. This streamlined approach to method development affords considerable cost savings as well as a significantly more robust and quality submission to regulatory authorities for faster drug approval.
Mia Summers is a Senior Business Development Manager in the Pharmaceutical and Life Sciences, QC and Manufacturing Division at Waters Corporation. She holds a degree in Chemistry from the University of British Columbia and has extensive experience in chromatographic method development from analytical screening to preparative purification, analytical development for process impurities and quality control testing of drug products, supporting regulatory filings for new drug applications. Prior to working for Waters, Mia worked as an analytical chemist for over 15 years in start-up biotechnology companies to large pharmaceutical organizations.
Supported by Waters Corporation
Since 1958, Waters Corporation has been in the business of making innovative analytical instruments that assist scientists in reaching their scientific goals, increase productivity and earn laboratory-based organisations a higher return on their investments in research, development, and quality control. Whether at work discovering new pharmaceuticals, inventing new and more effective ways to treat diseases, assuring the safety of the world’s food and drinking water supplies, monitoring and controlling pollution, or conserving the world’s greatest art treasures, scientists worldwide rely on Waters liquid chromatography and mass spectrometry products.
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