Implementación de un sistema de gestión para el cumplimiento de bpm arcsa en el laboratorio omegalab en el cantón pillaro, Tungurahua

Abstract

The aim of the current research work was to implement a management system for the compliance of good manufacturing practices (GMP) at the National Agency of Regulation, Control and Sanitary Surveillance (ARCSA), this research was carried out at the OMEGALAB laboratory, located in Píllaro county, Tungurahua province, through a non-experimental design study with a qualitative approach and descriptive type. The study population consisted of the cosmetic products produced in the laboratory, together with the personnel, raw materials, equipment, conditioning materials and processes. The research had three stages which were: evaluation of the current situation in the production line for the compliance of GMP and ARCSA guidelines, development and implementation of a quality manual in the production line to ensure quality and safety of cosmetic products. The results of the initial evaluation were 50% noncompliance related to organizational parameters, 17.25% in sanitation and hygiene, 50% in maintenance and services, 9.10% in storage and distribution, 15.28% in handling inputs, 18.18% in quality assurance and 31.25% in facilities. The quality manual was prepared to guarantee compliance with good manufacturing practices, through the design of standard operating procedures (SOPs) on personnel functions, organization of the facilities, control of environmental conditions, inventory control, product dispatch, among others, which were according to the needs of the facilities and allowed establishing quality guidelines, achieving a final compliance of 98.30% in the parameters evaluated. It was concluded that the implementation of a management system allowed a compliance of the GMP and ARCSA quality guidelines in the cosmetic laboratory. It is recommended for the technical manager to control and verify the compliance of good manufacturing practices.