Résumé
The pharmaceutical industry faces various risks that can compromise the quality of medications, potentially leading to adverse impacts on public health. To address these challenges, companies implement a risk management system in compliance with good manufacturing practices (GMP). Among these risks, there is the possibility of a "mix-up" a specific case of cross-contamination, which refers to the inadvertent mixing of two different products. This poses hazards to patient safety and has consequences for the responsible company and the medication market. Managing the mix-up risk has become increasingly crucial over the years. To mitigate this risk, a rigorous approach to quality risk management is essential, following the principles outlined in ICH Q9 and utilizing appropriate tools. Potential sources of mix-ups are diverse and can occur at any stage of the medication manufacturing process. These issues can be linked to technical or organizational failures, such as problems with product traceability, facility design, flow control, line clearance, and personnel training. A risk management tool like Failure Mode Effects Analysis (FMEA), which focuses on various compartments within a pharmaceutical industrial site, effectively identifies risks based on their severity. Following this risk assessment, different industry stakeholders, including production managers and quality assurance personnel, implement control measures to prevent mix-up incidents while adhering to GMP requirements. This study was conducted within a facility dedicated to the production of medications intended for human use, specializing in the manufacture of solid and semi-solid forms (such as pastes).