Abstract

RAMOS-GARCIA, María de los Ángeles; PARDO-GOMEZ, Georgina E.  and  AGUERO-LOPEZ, Beatriz. Evaluation of biological risk in quality control laboratories of the Finlay Institute. Vaccimonitor [online]. 2019, vol.28, n.1, pp.29-37. ISSN 1025-028X.

The Finlay Institute, dedicated to producing vaccines using biological agents, has for years been training personnel in the areas with the greatest risk potential, given the importance of protecting its workers, facilities, equipment and production. Therefore, risk assessments were started according to methods used by other countries, such as Spain. The main objective of this work was to evaluate the biological risk in Quality Control laboratories, such as the Bacteriology laboratory and the Biological Testing laboratory. Other objectives were to analyze the application of the current national Biosecurity legislation and propose a program of actions. The study was conducted in the last quarter of 2011 and the first semester of 2012. The observation method, checklists, interviews, storms of ideas and documentary analysis were used as quality instruments. The results showed that: both laboratories complied with the current Biosafety legislation, the most frequent risk factors were identified, including those with the highest level of risk and a program of corrective actions aimed at solving problems detected was obtained. The possibility of the application of a quantitative method, chosen to evaluate the risk and the implementation of the program of corrective actions with satisfactory results was demonstrated.

Keywords : Biological risk; quality control; biosecurity; vaccines.

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