Calidad Microbiológica De Productos De La Industria Farmacéutica, Cosmética Y Veterinaria En AQM. SAS De La Ciudad De Bogotá.

Abstract

Currently, it is an urgent need for the pharmaceutical and cosmetic industry to offer its consumers products that do not represent a risk to their health, which implies that they are free of physical, chemical and/or microbiological contamination. In this sense, the guarantee of safety for the use of these products is conditioned by both physicochemical analyzes and microbiological analyses; the latter seek to detect biological risks before marketing. The biological risk due to microbial contamination can occur throughout the production line, involving, among other aspects, manufacturing water, process water, and processing environments. Likewise, it is important to ensure that preservatives in pharmaceutical and cosmetic products are fulfilling their function. The objectives of this work were to determine the microbiological quality of different samples of pharmaceutical and cosmetic products, manufacturing waters and environments, comparing with the respective specifications established by the United States Pharmacopeia (USP) and British Pharmacopoeia (BP), also establishing, the effectiveness of the preservatives in these products by performing the preservative effectiveness test. The results showed that the analyzed samples of pharmaceutical products met the microbiological standards established by USP 1111, the cosmetic products met the guidelines of Resolution 2120 of 2019 of the General Secretariat of the Andean Community of Colombia, for their part, the products veterinary and homeopathic pharmacists met the specifications of the BP, appendix XVI H section C and XVI H section B, respectively; The results of the preservative test on samples of pharmaceutical and cosmetic products analyzed demonstrated that the preservatives met their effectiveness in accordance with USP 51; Additionally, the results of the microbiological tests of manufacturing/process water samples were in accordance with the provisions of the NTC 5395 of 2005 for drinking water and USP 1231 for type I, type II water. Finally, the environmental microbiological suitability of the processing areas of pharmaceutical matrices, cosmetics and products for veterinary use was verified, meeting the standards established by ISO 14644-1 2016.