Author(s)

MARÍA CASTRO-AGUILAR, JOSELYNE SOLÓRZANO, PAÚL CARRIÓN-MERO

Abstract

The pharmaceutical sector in Ecuador is undergoing significant development, notably for its contribution to health and well-being, job creation and its impact on the country’s gross domestic product. However, issues related to quality, health, safety and the environment have been identified in the industry’s operations, necessitating an assessment to enhance decision-making. The objective of this study is to analyse occupational health and safety conditions in the pharmaceutical industry by assessing compliance with the requirements of the International Organization for Standardization (ISO) 45001:2018 standard for the mitigation risks associated with its operations. The method is based on three stages: (i) Analysis of the operational and logistical situation of a pharmaceutical industry, with an emphasis on worker health and safety, (ii) Focus group on the situation of the pharmaceutical sector, combining the political, economic, social, technological, ecological, and legal factors method and the strengths, opportunities, weaknesses, and threats analysis to diagnose the current situation, and (iii) Proposal of strategies to establish occupational health and safety conditions. The selected pharmaceutical industry occupies an area of 38,000 m² and is dedicated to the manufacture of medicines related to human healthcare. It is certified in compliance with good manufacturing practices standards and holds ISO 9001:2015 certification. However, it does not have ISO 45001 certification, and with approximately 428 employees who perform their activities using machinery, handling waste and chemical reagents, and are exposed to particulate matter, it is prone to workplace incidents and accidents. The analysis indicates the urgent need for the implementation of a logistical and operational plan to prevent occupational and health risks, while addressing environmental issues that contribute to sustainability, through the proposal of strategies.

Keywords

ISO 45001:2018 standard, pharmaceutical sector, hygiene, accidents, occupational hazards