Risk management is a team-based approach fostering collaboration from a cross-functional team. Therefore, selection of people
in this team is crucial for the success of the exercise. Teams should include individuals skilled in process development,
manufacturing, validation, quality control, product characterization, method development, and quality assurance.
The various types of risk that pharmaceutical companies confront include patient risk (i.e, safety of drugs), operational
risk (i.e., operation safety and process variability), product-quality risk (i.e., endotoxin, viruses, host cell proteins,
host cell DNA, protein ligands, refolding agents, and process additives), financial risk (i.e., product loss, reputation,
and legal costs), and regulatory risk (i.e., FDA Form 483s, Warning Letters, product recalls, seizures, and legal actions)
(3). An appropriate risk analysis can minimize process risk.
Figure 1. A Fault-Tree Analysis for production of mAbs. (Figures courtesy of the authors)
The various tools available for risk analysis are fault-tree analysis (FTA), failure-mode-effect analysis (FMEA), Ishikawa
diagrams, hazard analysis, and criticalcontrol point (HACCP). In the report, Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals, expert committee members of the World Health Organization discuss FTA and FMEA in detail (4).