Desarrollo e Implementación de un Sistema de Análisis de Riesgos y Puntos Críticos de Control (HACCP) en la elaboración de la tableta recubierta de nifuroxazida y atapulgita en el Laboratorio Neofármaco del Ecuador CIA.LTDA.

Abstract

Currently, the Analysis and Critical Control Points System (HACCP) in the pharmaceutical industry is of utmost importance, this is because it allows the identification of errors or hazards that may occur at each stage of the process, affecting the integrity or safety of the product. It should be noted that in 2018 ARCSA annexes HACCP to its system through the Methodology for the implementation of HACCP in Pharmaceutical Laboratories. In the present project, the objective was to develop and implement a HACCP System in the production line of a coated tablet of nifuroxazide and attapulgite in the laboratory Neofármaco del Ecuador, for that, the methodology proposed by the WHO based on 7 principles divided into 12 steps was used, through the use of severity matrices, probability and a tree, biological, chemical and physical hazards were identified. Applying the aforementioned methodology, four critical control points (CCPs) were identified: the count of microorganisms in the weighing process (CCP-B1), in the manufacturing process two CCPs were found, the formation of the frost point (CCP-F1) and the resting time of the granules before drying not to exceed eight hours (CCP-B2), and finally, in the packaging process, the control of the tightness of the blister (CCP-Q1). As the CCPs were established, critical control limits were defined for each of them, assigning qualitative and quantitative values. Finally, a PRO-AS-HACCP-026 protocol was implemented, in which a history log was attached to facilitate monitoring and verification for the CCPs.