ICH Q3D Guideline For Elemental Impurities Testing & Risk Assessment

ICH Q3D Guideline elemental impurity testing and toxicological risk assessment supporting your implementation of elemental impurity programs

The ICH Q3D Guideline for elemental impurities presents major challenges to testing and risk assessment within the pharmaceutical industry. These challenges are related to the requirement to meet current stringent limits for specific elements as drug product impurities, and to assess patient risk due to exposure to such impurities.

ICH Q3D promotes a risk-based approach to assessing the presence of elemental impurities in drug products and focusses on the assessment of actual toxicological risk to the patient as it relates to the relevant route of administration for a given drug product. The Guideline includes three parts: the evaluation of the toxicity data for potential elemental impurities; the establishment of a Permitted Daily Exposure (PDE) value for each element of toxicological concern; and, the application of a risk-based approach to control elemental impurities. 

Our elemental impurities experts and toxicologists can help you to develop a compliance strategy to achieve successful implementation of ICH Q3D requirements. Intertek's teams facilitate the process through the design of tailored analytical programs based on wide experience of pharmaceutical impurity analysis and in-depth knowledge of elemental impurity testing and the ICH Q3D guideline, along with years of experience in conducting toxicological risk assessments. We can provide screening studies and data to aid risk assessment, if this does not already exist, or develop and validate methods tailored to the clients’ specific products.

Our laboratories utilise inductively coupled–optical emission spectroscopy (ICP-OES) and inductively coupled–mass spectrometry (ICP-MS) to perform elemental impurity testing in accordance with pharmacopoeial procedures (such as USP General Chapter <232> and Chapter <233>), or suitable alternative procedures. Our scientists are skilled in the selection of method preparation (including microwave digestions) and instrumentation based on your products sample matrix and the required limit of quantitation (LOQ).  Our toxicologists evaluate the generated data and perform toxicological assessments to help you understand the potential risks to patients due to exposure to elemental impurities in your drug products, derive relevant PDE values for the impurities (where necessary), and prepare written reports that can be submitted to regulatory authorities as needed.

With over 20 years of experience in assessing elemental impurity contamination in drug substances, excipients, drug product manufacturing, and container closures, and with decades of experience in conducting toxicological risk assessments, our analytical scientists and toxicologists apply the right approaches for your samples. Our expertise can help you to address potential patient risks and overcome elemental impurity challenges through our cost effective and efficient services.

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