In the current trend of contract manufacturing across the world, drug product manufacturing is getting stringent and competitive. The global health authorities are active and synchronized in setting-up new standards like never before to ensure drug product quality and patient safety. The quality guideline of ICH Q3D: Elemental impurities, is one such guideline that has been strategically prepared and is being implemented in phased manner across the ICH regions of EU, US, Japan and in Australia.
All the new drugs in pipeline and all the authorized drug products are mandated to comply with the guideline by Dec, 2017. From 1st of Jan, 2018 the elemental impurities present in the drug products must be assessed throughout the ICH region as per ICH Q3D. With many products being manufactured, organizations may find it challenging to prepare and comply with this mammoth requirement.
Freyr supports its clients to prepare elemental impurity risk assessment reports. Toxicology team at Freyr works with its clients to attain the possible levels of acceptability for each elemental impurity in drug product based on the dosage and other relevant information available. Most of the times, Freyr’s conclusion has found the levels of impurities well within the limits; there are instances where Freyr has suggested its clients to consider having control measures or mitigation plans to comply with the guideline. Freyr had adapted a unique approach to prepare risk assessment which involves:
This process allows prediction of expected and accepted limits of elemental impurities during pre-assessment, and also aid to reach a reasonable justification in the final- assessment.
- End-to-end understanding in impurity and cross-contamination assessment across the GMP arena
- Calculation of PDE for APIs,
- Qualification of solvents as impurities according to Q3C
- Calculation of MACO for drug product, etc.
- Blend of toxicology and GMP experts to assess the risk and suggest mitigation with practical approach towards the issues
- Compliance strategies to drug product manufacturers