Directiva ICH Q3D. Impurezas elementales

The main objective of ICH Q3D directive is to limit the presence of elemental impurities that are potentially toxic in human medicinal products.

Its implementation started in June, 2016 for new registers and December, 2017 for the commercialized products already in the market.

Qualipharma carries out the risk assessment for the ICH Q3D application following the basics below:

  • Development of a study based on the available informatione
  • Elemental impurities identifications
  • Strategy definition (components / products)
  • Risk Assessment for every critical component
  • Definition of the Analytical Plan
  • Examination and interpretation of the measurement results
  • Control definition (if applicable)
  • Completion of regulatory documentation and final report

The strategy will be defined by our experts in order to minimize the economic impacts and to accomplish the regulatory requirements for the ICH Q3D implementation.

  • Continuous processes improvement
  • Work /Process resources optimization