The application of hazard analysis and critical control points and risk management in the preparation of anti-cancer drugs

Objective. To apply the Hazard Analysis and Critical Control Points methodto the preparation of anti-cancer drugs. To identify criticalcontrol points in our cancer chemotherapy process and to proposecontrol measures and corrective actions to manage these processes. Setting. The Hazard Analysis and Critical Control Points applicationbegan in January 2004 in our centralized chemotherapy compoundingunit. From October 2004 to August 2005, monitoring of the processnonconformities was performed to assess the method. Methods. According to the Hazard Analysis and Critical Control Pointsmethod, a multidisciplinary team was formed to describe andassess the cancer chemotherapy process. This team listed allof the critical points and calculated their risk indexes accordingto their frequency of occurrence, their severity and their detectability.The team defined monitoring, control measures and correctiveactions for each identified risk. Finally, over a 10-month period,pharmacists reported each non-conformity of the process in afollow-up document. Results. Our team described 11 steps in the cancer chemotherapy process.The team identified 39 critical control points, including 11of higher importance with a high-risk index. Over 10 months,16 647 preparations were performed; 1225 nonconformities werereported during this same period. Conclusions. The Hazard Analysis and Critical Control Points method is relevantwhen it is used to target a specific process such as the preparationof anti-cancer drugs. This method helped us to focus on theproduction steps, which can have a critical influence on productquality, and led us to improve our process.