Modern Perspectives On Method Development

By Stephanie Harden

The goal of the analytical method developer is to design a method that can be used to check specific quality attributes of the drug, and therefore whether it is fit for purpose. A well-designed procedure will achieve the accuracy and precision and any other goals required to demonstrate that a product of consistently high quality is being manufactured.

Many companies are interested in adopting enhanced approaches to methods, as outlined in the new ICH Q14 and USP 1220 guidelines, and are looking to benefit from potentially greater regulatory flexibility to make changes to validated methods. Through the adoption of modern approaches to designing and managing analytical procedures, companies will have a better understanding of their products and procedures as well as processes for change management.

Improved understanding will enhance regulatory confidence in their ability to ensure quality products. In addition, well-designed and -managed methods can be more readily transferred between laboratories and across different technology platforms and successfully utilized for decades. Risk management and risk mitigation are very strong motivating factors driving pharmaceutical companies to adopt modern approaches to method development.

Hear from Dr. Fadi Alkhateeb, a Waters Senior Separations Scientist on the approach and tools used to design and develop fit-for-purpose methods.