Topic 1. Challenges and Considerations for Implementation of ICH ...

Output Example 1-Linking Material attributes and
process parameters to DS CQAs- development of
Design Space
� Submissions tend to be hybrid and there is a clear acceptance that this is not
bad
� There is conflict over meaning of QBD terms within organizations
� General agreement that organizations are not comfortable using term design
space in files
� Design space is submitted and approved by definition
� Statistics are not the only way to define a design space
� DS allows that changes within DS are allowed.
� Design space is useful for managing deviations outside the batch sheet and
allows change due to human and mechanical variability as long as it is filed!
� Use of the term PAR is contentious for some.
� Piecing together unit operations into a holistic CS across operations is more
difficult than defining a design space for a unit operation.
� Statistical analysis not always necessary but it add greater understanding of
variation
� How do we file and present DS