[Risk assessment related to galenic products].

The risks associated with the preparation of galenic products prepared at a local pharmacy have been hypothesized and evaluated, also carrying out a microbiological environmental monitoring of the used surfaces. Three possible situations risk were evaluated: the first one related to the physical separation of the production phases (medium risk of occurrence), the second to the failure to restore hygienic conditions in the transition from different formulations (high risk of occurrence), the third to contamination caused by the operator itself (unacceptable risk of occurrence). This last analysis was supported by the microbiological data of environmental sampling that showed procedural errors of the operator during the cleaning phases. From our assessments it is advisable to apply a simplified system of self-control based on risk assessment and validation of critical phases including cleaning procedures for the galenic preparations.