Quality by Design (QbD) is an approach that has been implemented in many manufacturing settings and across a broad range of industrial sectors. Its application is ever widening to cover a large number of processes that may previously have been considered to be outside its remit or grasp. In recent years, the application of the QbD approach to freeze-drying has been the subject of a small number of published studies, although there is arguably a long way to go before Best Practice can be agreed and opinions harmonized.
This half-day Workshop on QbD in Lyophilization will cover a number of aspects of the QbD approach and how it might be successfully applied to the freeze-drying process, as well as upstream activities (formulation, filling, loading) and postdrying issues.
Topics to be covered include:
- Can the QbD appraoch be applied to formualtion and cycle development as an integrated process?
- How can the different risks arising within the freezing and drying stages of the process be assessed/accommodated?
- Is it possible to find a good balance of desktop studies and practical freeze-drying that won't be unnecessarily onerous?
- What level of detail should we go in to assessing the risk and generating supporting data?