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Conduct EHS Assessments to Assess Business Continuity and Supply Risks 

In February 2019 Rohner Chem, a Swiss contract manufacturing organization (CMO) supplying chemical intermediates and active pharmaceutical ingredients (APIs) to the pharmaceutical industry for over 113 years, was inspected by Basel's Construction & Environmental Protection Directorate (BUD).  Findings from the inspection included approximately 15 million liters of industrial wastewater that had entered the subsoil since November 2018. ?  Since they couldn't meet the regulatory requested deadlines for remediation, their customers abandoned them and they were closed by July 2019 for .

Would an EHS assessment for business continuity and supply risk have "red-flagged" this site?  Maybe.

There were indications that conditions were not optimal.  In February 2016, an explosion at the site injured two employees and damaged parts of the production facilities.  Would an EHS management system assessment have found this to be problem and "red-flagged" the company for further evaluation?  Maybe.

Most pharma companies will perform site assessments, primarily driven by Quality Assurance issues, before signing contracts with CMOs.  Quality of the drug supply is a requirement, and other project team members may participate in the process as necessary.  However, EHS (environmental health and safety) staff not always involved Due to the health, safety and environmental risks of the processes, operations, and facilities EHS participation is very important. 

SafeBridge and its affiliated companies has an experienced staff of EHS professionals and engineers with technical and practical experience in pharma and biopharma to conduct independent third-party assessments.  We can also assess the capabilities of companies to safely manufacture potent and highly potent APIs and drug products.  In addition, our SafeBridge Potent Compound Safety Certification program, has been designed to evaluate these capabilities for CMOs.  The program is comprised of 60+ elements and provides a rigorous assessment of "hardware" (containment and controls) and "software" (procedures and practices) and compares the CMO to industry standards in potent compound safety.  A SafeBridge-certified company needs to meet these standards for the drug innovator to have confidence that they are a "contender" and not a "pretender" in potent compound safety.

For more information on our capabilities to assist drug innovators and CMOs in EHS and potent compound safety facility, program and process assessments, for business continuity or due diligence, please contact Allan Ader at [email protected] or Charlyn Reihman at [email protected]

As an overview of Occupational Toxicology, Dr. Vancza's lecture reviewed the historical and regulatory timelines of the field, beginning with the first observations of occupational disease made by Paracelcus and Ramazzini and continuing through the establishment of today's NIOSH and OSHA.  

She subsequently explained the risk paradigm in the workplace, covering the three hierarchies of hazard assessment, controls, and exposure assessment, with a particular focus on the occupational toxicologist's role in each area.  

Quantitative and qualitative hazard assessment methods and documentation were discussed, along with their practical applications as well as other risk communication tools.  

She concluded with summaries of environmental/biological monitoring and medical surveillance programs, and then offered recommendations for increasing worker awareness.  

40th Annual American College of Toxicology Meeting