Biomedical Engineering Reference
In-Depth Information
Performance
parameter
(product quality, etc.)
Characterized space
Design space
Operating space B:
Multi facility production
Process improvement
PVAC
Operating
space a
Operational parameter
(pH, temperature, etc.)
OR (A)
AR
Figure
5.12.
Design space philosophy enables flexibilities in manufacturing and regulatory
filing. AR, acceptable range; PVAC, process validation acceptance criteria; OR, operating range.
5.8 DEFINITION OF VALIDATION ACCEPTANCE LIMITS
Process validation provides documented evidence with a high degree of assurance that a
specific process at manufacturing scale will consistently produce a product meeting its
Results in
Upstream unit OP performance
Downstream unit OP performance
Key
Critical
Key
Key
Non-key
Non-key
CR
CR
For example, pH
For example, pH
= PVAC
Figure
5.13.
Classification of OPs based on performance data derived within the characteriza-
tion range with respect to key and critical performance parameters. Note: The gray areas
represent the noncharacterizeddesign space for theoperational parameter under investigation.
PVAC, process validation acceptance criteria.
