The importance of toxicological risk assessment for drug products and biologics

Exposure to extractables or substance chemicals residue can compromise patients’ safety. Identifying and limiting the risks associated with hazardous materials is imperative to comply with regulatory requirements accross the pharmaceutical and medical devices industry.

A toxicological risk assessment is the overall goal of conducting extractables and leachables studies. A toxicological risk assessment must be performed by a qualified toxicologist on all leachables found in the final drug product at concentrations above the AET. In the case where there insufficient literature data is identified, studies must be conducted in order to complete the risk assessment.

We have the capability to evaluate compounds by referring to both toxicological databases and QSAR methods. We are experienced in performing toxicological analyses on pharmaceutical container/closure systems according to standards such as ISO 10993-17 and ISO 18562 and guidance documents from the FDA and PQRI.

Our dedicated expert team of 40+ toxicologists and consultants at Eurofins Regulatory & Consultancy Services, a board-certified team, including one European Registered Toxicologists (ERT) and one HAS Consultant, will provide top-tier services to meet global regulatory compliance. Our one-stop-shop solution and holistic approach addresses client needs, while ensuring project timelines are consistently met.

Services

Toxicological risk assessment for drug products & biologics

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  • E&L validation plan
    Implementation of the optimal regulatory strategy based upon the specific drug product and drug substance
  • Data gap analysis and quality review
    Evaluation of already generated extractable and leachables data and their application to a specific drug product and drug manufacturing process
  • Change assessment for the evaluation of E&L related impact within the manufacturing process and primary packaging
  • Risk assessment for a risk-based approach to E&L testing strategy
    Risk level definition for each process components and primary packaging as well as an appropriate risk mitigation strategy
  • Toxicological risk assessment on the compound of potential concern identified in the E&L studies
    Performed by expert toxicologist (including ERT)
  • Permitted daily exposure to evaluate toxicological profile of compounds
    Includes expert review relevant data and scientific literature, use of in silico methods, QSAR and read-across
  • Evaluation of process related impurities and special impurities such as nitrosamines
  • Technical support of our consultant in the interaction with regulatory agencies and to reply to deficiencies  
  • Extended experience in project management to help clients navigate into the complexity of an E&L study