Implementación del sistema de análisis de riesgos y puntos críticos de control (HACCP) y su integración al sistema de gestión de calidad del laboratorio Neofármaco del Ecuador Cia. Ltda

Abstract

The objective of this research work was to implement the Hazzard Analysis and Critical Control Points System (HACCP) and integrate the Quality Management System of the laboratory Neofármaco del Ecuador Co. Ltd. In the period August 2020 - January 2021. POE-NAS-055 was carried out, in which the 7 principles established in Annex 7 of Report 37 of the World Health Organization were detailed. The implementation was carried out through the use of 12 steps. A multidisciplinary HACCP team was formed, composed of general management, heads, technical representative and thesis students. The product, process and intended use of the product was described, based on the protocol of weighing, manufacturing, packaging / sealing, packaging and information from the technical sheet and sanitary registration. The flowchart was developed using Microsoft Visio and verified on site. Physical, chemical and biological hazards were analyzed at each stage of the process, through the use of the failure and error matrix (MT-NAS-001), and based on this information, critical control points (CCP) were identified through the use of the decision tree. Qualitative and quantitative critical limits were established for each CCP (MT-NAS-002). A CCP monitoring system was established, under the format F-AS-031 and MT-NAS-002. Finally, immediate corrective actions and verification procedures were established for each identified CCP, in MT-NAS-002. All the information collected was documented in PRO-AS-HACCP-001 and the integration of the HACCP System to the company's Quality Management System was carried out through the implementation of CCP HACCP to the drug manufacturing process, as well as the annex of HACCP records (F-AS-031 and R-AS-058) to the batch history. In conclusion, 65 hazards were determined, of which 9 were CCP HACCP