Risk assessment of chemicals, e.g. impurities

TKT has provided support to many customers in issues related to impurities in APIs and drug products. In several cases the assignments have been of business-critical nature and involved problem solving. We offer e.g. the following services:

  • Risk assessment and qualification strategies for impurities in drug candidates and drug products in compliance with the ICH Q3 guidelines
  • ICH M7 compliant reports on assessment and control of mutagenic impurities in pharmaceuticals
  • Determination of Permitted Daily Exposure (PDE) in compliance with the EMA guidance
  • Derivation of Occupational Exposure Limits (OEL/OEB)
  • Risk assessment and qualification strategies for leachables/extractables in pharmaceutical products or in medical devices (according to ISO 10993, see also “Medical Devices”)
  • Evaluation of pharmacological excipients

For further information and requests for quotations, please use our contact form, or contact any of our consultants.

Drug development