Risk analysis in the pharmaceutical industry: Development of a standardized operating procedure in a pharmaceutical company in Costa Rica
DOI:
https://doi.org/10.33304/revinv.v16n2-2021008Keywords:
Risk analysis, FMEA, pharmaceutical industry, SOP, Quality Management SystemAbstract
The purpose of this study was to develop a standardized operating procedure for a pharmaceutical company in Costa Rica. In order to achieve that, an unstructured personal interview was done with the Quality Control manager. Subsequently, there was a research in different databases to learn about the analysis and management of risks and the use of the Failure Modes and Effects Analysis. On addition to that, the document related to its use was developed through the generation and revision of six different versions. Finally, 10 people from the company were trained. As a result, one of the elements that requires the most work for the implementation of the procedure is the adequate definition of the parameters of severity, probability of occurrence and probability of detection. Furthermore, the presence of people from different departments is necessary, since they provide a different perspective from which a given risk can be addressed.Downloads
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