Biomedical Engineering Reference
In-Depth Information
TABLE 8.2 Three Stages of Process Validation Lifecycle
Lifecycle Stage
Implementation Elements
ICH Q10 [17]
Stage 1: process design
• Formulation, process development, and process
understanding (primarily R&D activity)
• DoE, process modeling
• Process characterization
• Initial process ranges (averages and variations)
• Determination of process variables (e.g., CQAs, CPPs,
KPIs)
• Initial control strategy established
Knowledge Management/
Quality Risk Management
Stage 2: process qualification
a) Design of facility; qualification of
equipment and
utilities
b) Process
performance qualification
• Equipment and utilities qualification
• Systems verification (suitability)
• Conformance phase or initial manufacturing
• Scalability and process performance
• Primarily manufacturing-scale activity
• Confirm/verify data at commercial scale
Stage 3: continued process verification
• Product and process monitoring systems (e.g., ongoing
monitoring, trending, continuous quality verification,
annual product review)
• Continuous improvement
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