Development and implementation of a multi-attribute quality robustness scoring framework for lifecycle management of diversified pharmaceutical portfolios

Abstract

Maintaining consistent product quality in multi-site pharmaceutical manufacturing environments necessitates a transition from reactive monitoring to proactive, quantitative risk assessment. This study presents the development and implementation of a structured, quantitative product robustness score framework, Multi-Attribute Quality Robustness Scoring (MAQRS) model, designed to evaluate product health across its entire lifecycle. Seven key performance indicators (KPIs), i.e., Deviations, Out of Specification (OOS), Out of Trend (OOT), Process Capability, Market Complaints, Product Stability and Manufacturing Efficiency, were integrated into a weighted, 100-point scoring algorithm. Data normalization criteria were established to isolate true process variability from extraneous factors such as human error or equipment failure. MAQRS categorizes products into three tiers- Robust (>85), Moderate (70–85), and Needs Remediation (<70). A Product Resilience Index (PrRI) was derived to prioritize corrective actions. Illustrative case studies demonstrate the model’s ability to differentiate between superior process control and high-risk profiles requiring immediate intervention. The MAQRS provides a validated, quantitative methodology for synthesizing fragmented data sets. It enables organizations to prioritize continuous improvement, enhance process reliability, and uphold regulatory expectations.