The pharmaceutical industry has traditionally controlled analytical methods via a well-defined sequence of development, validation and transfer exercises in line with agreed standards such as ICH Q2. This approach limits the scope for technological innovation or improvements in quality or
efficiency of methods for established products.
This symposium will explore recent advances in thinking around the management of analytical method lifecycle, based on meaningful quality attributes and an understanding of critical parameters within a "design space" for an analytical method, as part a more holistic approach to product
development and quality control. The philosophy and practice of this approach in product development and commercial manufacturing will be
explored, highlighting the challenges as well as potential benefits in terms of better measurements at lower cost, and exploring the current state of
dialogue between industry and regulators in this area.
efficiency of methods for established products.
This symposium will explore recent advances in thinking around the management of analytical method lifecycle, based on meaningful quality attributes and an understanding of critical parameters within a "design space" for an analytical method, as part a more holistic approach to product
development and quality control. The philosophy and practice of this approach in product development and commercial manufacturing will be
explored, highlighting the challenges as well as potential benefits in terms of better measurements at lower cost, and exploring the current state of
dialogue between industry and regulators in this area.
