The same QbD concepts applied to the design and control of manufacturing processes can also be applied to analytical measurement systems. Advantages of doing so include better understanding of method capability, the development of more robust methods, facilitation of manufacturing process improvements, flexibility to make changes to certain operating conditions and the establishment of a framework for evaluating & implementing new technology. Authors are invited to share how they have applied QbD principles in their design and prosecution of measurement systems.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Pharmaceuticals (15b)