Integrating Business Impact Analysis, Scenario-Based FMEA, and Business Continuity Planning in Pharmaceutical Manufacturing: A Product-Level Case Study

Abstract

This study evaluated the product-level integration of Business Impact Analysis (BIA), scenario-based Failure Mode and Effects Analysis (FMEA), and Business Continuity Planning (BCP) for a selected finished medicinal product. A single-site case study was conducted for cefixime 400 mg film-coated tablets in a GMP-regulated pharmaceutical organization. Data were collected over approximately six months through four structured questionnaires, documentary and operational-record review, facilitated interviews, and cross-functional consensus sessions. BIA established Maximum Tolerable Downtime (MTD), Recovery Time Objective (RTO), and Work Recovery Time (WRT). Twenty-five de-identified scenarios, were assessed using predefined 1–4 scales for severity, frequency, and detectability; RPN was calculated as S × F × D. IT and Technology had the shortest recovery requirement (MTD 48 h, RTO 24 h, WRT 24 h). Twelve scenarios were low risk and 13 were medium risk; none was high or critical. Material-transport interruption and adverse commercial and market conditions had the highest RPN of 16. Thirteen scenarios required additional controls. Sensitivity analysis showed that selected medium risks could move to high risk after a one-level score increase. The integrated approach supported transparent recovery prioritization and translation into product-specific continuity actions. Findings are context-specific and require prospective testing and replication.