Working in a highly-regulated environment such as a hospital pharmacy comprises risk assessments. Errors and incidences can arise at every step from production to procurement, storage, distribution, and clinical trials. GMP, GCP, CAPA (corrective and preventive action), are designed to steer processes in a way that errors are prevented and, if occurring, are effectively corrected. Qualified persons (QP) must assess all risks, which might have a negative impact on the product quality and which are linked to their human resources, fixed and mobile infrastructure, equipment, processes in force in manufacturing, cleaning, disinfection, analytical, storage and distribution steps. The effectiveness of coping strategies must be proven by the qualified persons to inspectorates.
The FMEA (failure mode and effect analysis) is a tool to effectively assess risks arising from such processes. It calculates the risk as the product of its probability of occurrence, its importance in terms of danger, and its detection chances.
After the session, the participant should be able to:
Describe the GMP-requirements on risk analysis;
Outline challenges and limit risks as related to corrective and preventive actions (CAPA);
Relate the number of patient cases with the importance of the risk;
Conclude on the minimal risk prevention activities to be performed by different types of production units;
Implement a suitable risk prevention activity in his/her own hospital; and,
Perform a FMEA for the assortment issued from own production.