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These strategies are based on product, formulation, and process
understanding and include control of the CQAs and CPPs. Control
strategies can be implemented for both real-time and end-product testing.
Several illustrative examples are provided in the ICH Q8 guideline on
use of risk assessment tools, depiction of interactions, and presentations
of design space. Table 1.1 represents comparison between the traditional
and QbD approaches, regarding different aspects of pharmaceutical
development and product lifecycle management (according to the
ICH Q8 guideline).
Comparison between the traditional and QbD
approach (ICH Q8 guideline)
Table 1.1
Aspect
Traditional
Enhanced, QbD approach
Overall
pharmaceutical
development
- Mainly empirical
- Developmental
research often
conducted one
variable at a time
- Systematic, relating mechanistic
understanding of material
attributes and process parameters
to drug product CQAs
- Multivariate experiments to
understand product and processes
- Establishment of design space
- PAT tools utilized
Manufacturing
process
- Fixed
- Validation primarily
based on initial
full-scale batches
- Focus on optimization
and reproducibility
- Adjustable within design space
- Lifecycle approach to validation
and, ideally, continuous process
verifi cation
- Focus on control strategy and
robustness
- Use of statistical process control
methods
￿
￿
￿
Process
controls
- In-process tests
primarily for go/no go
decisions
- PAT tools utilized with appropriate
feed forward and feedback controls
- Process operations tracked and
trended to support continual
post-approval improvement efforts
Product
specifi cations
- Primary means of
control
- Based on batch data
available at time of
registration
- Part of overall quality control
strategy
- Based on desired product
performance with relevant
supportive data
 
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