PROCESS LIFECYCLE VALIDATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 185

35%

30%

25%

20%

15%

10%

5%

0%

Input parameters

Figure 8.1 Pareto chart for relative importance of input parameters for DoE.

Potential CPPs

Process risk
identification or
preliminary risk
assessment

Potential CQAs

Existing validation/
process know ledge

Risk assessment
report approval,
including decisions

Does the process
parameter range pose
risk to product quality
and patient safety?

No

[New/additional
validation not required]

Check against risk
assessment, any
residual or new risk?

Yes

Study design,
rationale, and
protocol approval

Data summary
and
report approval

Study
execution

Figure 8.2 Incorporating risk assessment into study design.