Abstract

FERNANDEZ-ACOSTA, Emilce Lorena; FRETES DE AQUINO, Sonia Lorena; GONZALEZ RUIZ DIAZ, Rocio  and  DOMENECH, María Gloria. Risk analysis of an objectionable microorganism in a dietary supplement for batch release. Mem. Inst. Investig. Cienc. Salud [online]. 2021, vol.19, n.3, pp.115-118. ISSN 1812-9528.  https://doi.org/10.18004/mem.iics/1812-9528/2021.019.03.115.

Contamination with objectionable microorganisms in non sterile pharmaceutical products may have the potential to decrease or inactivate the pharmacological and therapeutic activity of the active principle and therefore represent a danger of great risk to the health of the person who is being treated with drugs, additionally, the presence of these microorganisms, depending on their ability to produce disease in susceptible hosts, can cause unexpected infections or diseases that affect the patient or consumer of these non sterile drugs. The objective of the work was to develop a microbiological risk analysis of objectionable microorganisms in a dietary supplement of a pharmaceutical industry as a tool in safety management. This was an observational-descriptive cross-sectional study. In the pharmaceutical industry (in the dietary supplement) a risk analysis was developed studying all the parameters, having as a result that the soft capsules with Krill oil do not present objectionable microorganisms of the pathogenic type, as a low risk product, therefore it is approved for batch release following these parameters. In Paraguay there are no regulations about the analysis of objectionable microorganisms, in comparison with other countries such as Argentina, and for a long time in the US and European countries (due to FDA reports). Therefore, this work is relevant and very vital important to establish national legislation with a view of the manufacture of safe, reliable and effective drugs.

Keywords : risk analysis; objectionable microorganisms; non sterile pharmaceuticals.

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