Impurities

Since the foundation of TKT, our experts have provided support to a large number of customers in issues related to impurities in drug products/APIs. In several cases the assignments have been of "business critical" nature and on many occasions involved problem solving. TKT offers e.g. the following services:

  • Permitted Daily Exposure (PDE) reports in compliance with the EMA guidance (See also "Chemical Risk Assessment"
  • Risk assessment and qualification strategies for impurities in drug candidates and drug products in compliance with the ICH Q3 guidances
  • ICH M7 compliant reports on assessment and control of mutagenic impurities in pharmaceuticals (Se also "Tools" and Genetic toxicology")
  • Risk assessment and qualification strategies for leachables/extractables in medical devices according to ISO 10993 (see also "Medical Devices")
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