Comprehensive EHS Program Development for Pharmaceutical Startup

OUR CHALLENGE

A newly established pharmaceutical manufacturing company faced the challenge of building their environmental, health, and safety (EHS) program from the ground up. With no pre-existing systems in place, they needed to protect their workers from potential exposures and to develop comprehensive solutions to ensure compliance with occupational exposure limits (OELs) for active pharmaceutical ingredients (APIs) . Additionally, the company had to develop safety data sheets (SDSs), establish effective industrial hygiene practices, and create a robust EHS program to meet both internal needs and regulatory standards. Without these foundational elements, the company risked falling short of compliance requirements and compromising worker safety before operations even began. 

OUR APPROACH

Our team implemented a comprehensive approach to address the company’s EHS challenges. Key actions included:  

• Designing the company’s overall EHS program, which incorporated best practices in occupational hazard and exposure banding, engineering controls, administrative controls, personal protective equipment selection, and environmental compliance.  

• Developing customized OELs and permissible daily exposure values for the APIs in use. 

• Creating several of the company’s SDSs to align with current industry standards and regulatory requirements.  

• Conducting thorough exposure assessments for APIs in collaboration with an engineering team to ensure robust, layered controls for worker protection while handling potent APIs.  

OUR IMPACT

The implemented solutions provided the company with a solid foundation for their EHS efforts. The long-term impact of these improvements positions the company for sustained success, ensuring their EHS program is scalable and adaptable. This foundation will allow the company to easily expand or adjust as they grow or as regulations evolve, preparing them to handle increasingly potent APIs and maintain compliance across various regulatory environments.