ISO 45001 : gap analysis of occupational health and safety in a pharmaceutical company in Lebanon

Abstract

The pharmaceutical industry is responsible for the development, production and marketing of medications. It is based primarily upon the scientific research and development of medicines that prevent or treat diseases and disorders and is regarded as one of the fastest growing industries worldwide. Modern scientific and technological advances are accelerating the discovery and development of innovative pharmaceuticals with improved therapeutic activity and reduced side effects. These advances create new concerns for protecting the health and safety of workers within the pharmaceutical industry. The newly published ISO45001:2018 standard helps any organization that wishes to establish, implement and maintain an Occupational Health and Safety Management system. This is accomplished by providing a framework to improve employee safety, eliminate hazards and reduce workplace risks. Consequently, it helps in creating better and safer conditions for employees. In Lebanon, eleven pharmaceutical manufacturers mostly produce their own off-patent branded generics, but equally produce patented drugs under license for multinational companies; some have also manufactured their own innovative products. None of these manufacturers has been certified nor assessed against the ISO 45001 standard yet. The aim of this study was to reevaluate the occupational hazards and risks encountered in the production and laboratory units of one of the manufacturing facilities in Lebanon, Benta Pharma Industries. Doing so, it will help the pharmaceutical industry in fulfilling one of the requirements of the ISO 45001 standard. This was achieved by spending hours as an intern at Benta, observing and collecting data. After completing the residency and rotation in each unit, a gap analysis was conducted. It was performed by comparing the recorded observations to the ILO Encyclopedia of Occupational Health and Safety- pharmaceutical industry labour standards-, the Good Laboratory Practices for Pharmaceutical Quality Control Laboratories in Lebanon according to the Lebanese Ministry of Public Health and the OSHA standards. Based on the collected data and the identified gaps, an action plan was proposed based on the adherence to the above standards, the aim of which is to improve the occupational health and safety conditions at Benta which will improve the occupational health and safety management system.