Cross-contamination Risk Assessment using FMEA tool

In pharmaceutical manufacturing facilities, products with different therapeutic properties and potencies are manufactured in shared spaces, which poses a potential risk for cross-contamination. During the manufacturing process, cross-contamination may occur due to the uncontrolled release of dust, gases/vapors, mix-ups with other materials, residues on equipment, and contamination from operator’s clothing. By implementing adequate facility design and manufacturing operations aligned with Quality Risk Management principles, the risk of cross-contamination can be controlled. If a shared facility is used for manufacturing pharmaceutical products, strategic controls for identifying and managing the risks of cross-contamination should be in place. This article provides a structured and systematic framework for the risk-based identification of the worst-case product and manufacturing process among the products manufactured in the solid oral facility, addressing the high risk of cross-contamination. Keywords: Cross-contamination, Contamination, Risk Assessment, Formal risk assessment, Quality Risk Management (QRM), Failure Mode Effect Analysis (FMEA), Oral Solid Dosage (OSD), Worst case, Contamination Control Strategies (CCS)