Biomedical Engineering Reference
In-Depth Information
frequent monitoring and allow the process to respond to any variation in incoming
attributes by modifying conditions through either feedback or feed-forward control such
that the desired outcome is still achieved. This can be accomplished as a response to
either a single or, in more advanced control situations, multiple inputs, and results in the
control of single or multiple parameters. Finally, product quality should be managed
throughout the product life cycle, and as new approaches are developed or new
knowledge and understanding are acquired, quality should undergo a process of
continual improvement, which is both simplified by the preceding practices and assumed
as a quality management principle.
13.4.1 Combining QbD and PAT
The scope of the different ICH guidances, and how they relate to each other, is shown
diagrammatically in Fig. 13.3, along with where QbD and PATare primarily applicable.
QbD and PAT are strongly interdependent, but it is also the case that certain aspects of
QbD do not require PAT for implementation, such as product or formulation design, and
equally, there are opportunities for PAT in areas outside direct process control, such as
monitoring equipment for continued fitness for use (e.g., environmental monitoring) and
cleaning. However, when it comes to direct control of process parameters and product
attributes, QbD serves an essential part by first defining the required design space. Once
defined, PAT is the execution tool that keeps the process in the desired space.
Supporting QbD principles with PAT allows the development of a dynamic process
that can respond to input variability. It follows that such a process should be better able
to respond to changes and facilitate the incorporation of improvements in process
technology, be it the changes in equipment or in critical processing aids such as resins and
filters [28].
Process
monitoring/
continuous
verification
Product
design
Process
design
Manufacturing
ICH Q8/Q8(R) - Pharmaceutical Development
PAT Guidance
ICH Q9: Quality Risk Management
FDA Guidance on Quality Systems (9/06)/
ICH Q10 - Pharmaceutical Quality Systems
Figure 13.3. The scope of recent guidances (with thanks to Dr. Moheb Nasr).
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