Biomedical Engineering Reference
In-Depth Information
Risk
analysis
(FMEA)
Upstream
process
Design space
definition
DOE
Characterization range
Acceptable range
Operating range
PC Models
Product
design
space
Set point
Process design space: key and critical
operational parameter values where all
resulting CQAs are within the pre-
established product design space
Figure
1.1. Illustration of the creation of process design space from process characterization
studies and its relationship with the characterized and operating spaces. The operating range
denotes the range in the manufacturing procedures and the characterization range is the range
examined during process characterization. The acceptable range is the output of the characteri-
zation studies and defines the process design space. Adapted from Ref. [5], by permission of
Advanstar Communications.
for postapproval submission. This is illustrated in Fig. 1.2, which shows that if the
process creeps outside the design space, process changes may be required to be made and
may require process characterization, validation, and filing of the changes to the
approved process design space.
•
Demonstration that process
can be performed at
commercial scale within the
design space
Process
characterization
•
Definition of design
space for a process
•
Establishing control
schemes (PAT) that
target optimal and robust
performance
Process
validation
Regulatory
filing
Process
monitoring
•
Filing of design space in
terms of key and critical
parameters and their
acceptable ranges
•
Monitoring of process performance with respect
to design space via multivariate analysis and other
statistical tools
•
If process creeps outside design space, consider
recharacterization, revalidation, and filing of the
extended design space
Figure
1.2. Application of the design space concept in process characterization, validation,
monitoring, and regulatory filing. Adapted from Ref.
[5], by permission of Advanstar
Communications.
