Elaboración de un manual de calidad para la implementación de la norma iso:22716 en la línea de cosméticos del laboratorio neo-fármaco del ecuador cia. Ltda.

Abstract

The aim of this work was to implement the Standard IS0:22716 in the cosmetic product line of Laboratorio Neo-Fármaco Del Ecuador CIA. LTDA, by means of the elaboration of a Quality Manual. For its implementation, a compliance and non-compliance matrix was developed for the diagnosis of the current situation of the cosmetics line based on the Standard ISO: 22716, harmonizing it with the Cosmetics Standard of the ARCSA (Agencia Nacional de Regulación, control y vigilancia Sanitaria). As a previous step, the different procedures, instructions and records of Laboratorio Neo-Fármaco Del Ecuador CIA. LTDA were reviewed. Subsequently, the products were classified according to their physical characteristics, these products were: solutions, emulsions and solids. The parameters such as time, speed, aspect, density and pH were considered to evaluate the critical points of the manufacturing process of each one of them. The most sold cosmetic products during the year 2021 were considered as part of the sample, being these: Jabón líquido NF®, Enjuague Bucal Bucosept solución®, Colonia El Caballito®, Jabón de Glicerina del Dr. Peña®, Jabón Detox carbón activado con caléndula y matico®, Protector Solar Sun Screen Antisol NF®. Finally, the information gathered was used to prepare the "Manual de Calidad ISO: 22716 Cosméticos", which was reviewed by the technical director and approved by the operations manager, and then socialized through scheduled meetings with the company's personnel. It was concluded that the implementation of the manual ensures compliance with current regulations related to the production of cosmetics. It was recommended to continue doing research projects to provide openness to pharmaceutical biochemists at the level of the pharmaceutical industry.