Toxicological Risk Assessment Centre of Excellence (TRACE)

Qualitative and Quantitative Health Assessments are an integral part of product development, manufacturing, and post-marketing surveillance. The process can be challenging, as it requires knowledge of the latest regulatory expectations (i.e., ICH, FDA, EMA, WHO). Product safety guidelines require establishment of safe levels for risk of cross-product contamination in multi-product facilities, extractables and leachables, mutagenic and non-mutagenic impurities, particle contamination, and volatile organic compounds. Furthermore, regulatory agencies require that excipients, degradants, contaminants, and residual solvents are present at levels that are scientifically justified and supported. To establish these safe levels, Health-Based Exposure Limits (HBELs) such as an acceptable daily exposure (ADE) [also known as permitted daily exposure (PDE)] may be established, while other qualitative assessments also may be needed (e.g., mutagenic impurity classification as per ICH M7 methodology), all of which are required to be performed by qualified, experienced, and board-certified toxicologists.

Occupational toxicology assessments involve hazard identification and establishment of an occupational exposure limit (OEL). During early drug development stages, when information on the active pharmaceutical ingredient is limited, a preliminary categorization and placement of the active pharmaceutical ingredient into a control band can be performed.

Intertek is a global leader in hazard identification and risk assessment through our understanding of the complex regulations and by providing comprehensive solutions for our clients. Total quality assured culture is key to all aspects of our work, professional training, and client relations. Our senior staff have extensive technical training, board-certification credentials, and decades of cumulative experience.

We can provide product safety and occupational toxicology assessments to support the R&D and manufacture of compounds in the pharmaceutical, biotechnology, and medical device industries.

Health-Based Exposure Limits

• Permitted daily exposure (PDE) calculation
• Excipient qualification
• Impurity assessment and qualification
• Extractables and leachables assessments (drugs and medical devices)
• Volatile organic compounds assessments (medical devices)
• Particle contaminant assessments
• F-value calculation for childproof packaging

Occupational Toxicology

• Occupational exposure band (OEB) assignment
• Occupational exposure limit (OEL) calculation
• Acceptable surface limit (ASL) calculation

Qualitative Assessments

• ICH M7-compliant mutagenicity assessments including in silico evaluation
• Nitrosamine assessment of active pharmaceutical ingredient and drug product 

Research Support & Issue Resolution

• Literature searches
• Authoring of literature reviews
• Authoring of white papers
• Authoring of expert reports

Quantitative and Qualitative Health Assessments are an integral part of product development, manufacturing, and post-marketing surveillance. Product safety guidelines require the establishment of safe levels for risk of cross-product contamination in multi-product facilities, E&L, mutagenic and non-mutagenic impurities, particle contamination, and volatile organic compounds

Our experts provide qualitative and quantitative toxicological support specializing in product safety and occupational toxicology to pharmaceutical, biotechnology, and medical device companies worldwide. We offer expertise to provide solutions for compliance with global regulatory agencies and practical timelines to accommodate the production process.

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