(466d) Design of a Pharmaceutical Manufacturing Process Using QbD Principles: The Challenge of Technical Transfer to Manufacturing and Lifecycle Development

The route of manufacture for product X is a convergent, multi-stage chemical synthesis that has been developed using QbD principles.

A description of the approach to chemical process development utilising QbD methodologies, to determine and control quality critical process parameters is provided.  A workflow from process assessment, through process understanding to development of a control strategy, providing a platform for technical transfer to commercial manufacturing is described.

The process involved in the development of a commercial manufacturing strategy to utilise the thorough process understanding, in order to ensure the provision of a robust commercial manufacture is also illustrated. 

Rising to the challenge of providing a robust chemical synthesis, adequately described in the registered manufacturing description in combination with supporting compliance during the product’s commercial lifecycle is essential.