Table 14 Interpretability and compliance evaluation using SHAP and LIME.
From: Intelligent information management enables quality-by-design in pharmaceutical production
Method | Key Contribution | Regulatory Alignment | Outcome |
|---|---|---|---|
SHAP | Global feature importance ranking (e.g., temperature, pH) | ICH Q8: Process understanding | Identifies most influential CPP–CQA linkages |
LIME | Local instance-level explanations for predictions | ICH Q9: Risk assessment and management | Provides traceability for batch-level decisions |
Combined | Integration of SHAP + LIME outputs into dashboards | ICH Q10 & Q11: Control strategy, lifecycle | Enhances transparency and regulatory acceptance |
