(332a) FDA Perspective On QbD for Analytical Methods

QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement.  QbD provides new opportunities and modern tools to utilize in analytical research and development. ICH guidelines and implementation strategies focused mainly on formulation and manufacturing design and development.  However, many of the QbD approaches and tools are applicable to analytical methods as well. The linkage between QbD and analytical method development and validation needs further development.  Inclusion of enhanced pharmaceutical development information, including analytical method development and validation studies, in the submissions will provide the applicants the opportunity for flexible regulatory approaches, recognizing however, the degree of regulatory flexibility is predicated on the level of demonstrated product, analytical method and manufacturing process understanding.   A summary of the progress made to date and the continued challenges facing the industry and FDA will be presented.