ICH guideline Q3D concerning elemental impurities is bringing new obligations to finished product manufacturers.
Medfiles provides support for clients in ensuring compliance with the ICH Q3D guideline. Service is always tailored to suit individual clients’ needs. Support is given from planning the risk assessment strategy to complete risk assessments including toxicological evaluations.
What does it mean?
Drug products are expected to comply with the limits presented in the ICH Q3D guideline for specific elements.
This does not necessarily lead to routine testing of elemental impurities from drug products as compliance can be demonstrated with a risk based approach. Finished product manufacturers can demonstrate the absence or low levels of potential impurities by supply-chain control. In such cases further testing of the finished product is not necessary. Risk assessment must be performed for all drug products.
Remember – the limits presented in the guideline are applicable to drug products. It is up to the drug product manufacturer to prove that the product and its components are adequately controlled for elemental impurities in order for the drug product to comply with ICH Q3D requirements.
Future changes in analytics
After implementation of ICH Q3D, references to the Ph.Eur. and USP heavy metals test will be deleted from monographs. The heavy metals test has its weak points when it comes to sensitivity, accuracy and specificity and it was therefore no longer considered adequate for the purpose of controlling the levels of potentially toxic elements. Use of modern techniques with specificity and adequate sensitivity to elements being tested is expected instead.
Compliance with the ICH Q3D guideline has been expected in the EU from new finished products from June 2016 and is expected from marketed products by December 2017. USP chapters <232> and <233> will become effective in January 2018.