What is the role of regulatory authorities in extending the application of QbD principles to chromatographic method development?
MW. The regulatory authorities recognize that robustness is a key attribute of any analytical method. The ICH guidance document, ICH Q2B Validation of Analytical Procedures: Methodology (November 1996) states “the evaluation of robustness should be considered during the development phase….” The challenge for chromatographic methods is that there has been no good way to do this. Robustness is evaluated during the validation phase where we are essentially testing it in to the method rather than building it in. So, the intention of the regulatory guidance document is to recommend an approach that builds robustness into a chromatographic method while the method is being developed. What do you see as the future of complementary analytical technologies? MW. The focus in the industry is on shortening drug development times while reducing operating costs. I see the path forward as being driven by the integration of technologies that streamline and automate the chromatographic method developm
