Do you need help establishing safe limits for your non-genotoxic impurities (NGIs)?
When a non-genotoxic impurity (NGI) is present above the qualification threshold, an impurity qualification becomes necessary. We can provide a weight of evidence assessment to determine a safe limit for your NGI.

Does your process involve a residual solvent not included in ICH Q3C?
If a solvent is not included within the ICH Q3C guidelines, an independent calculation is required to determine an acceptable intake. If relevant and robust data exists, we can perform a permitted daily exposure (PDE) risk assessment to establish an acceptable limit for your residual solvent.

What if there is insufficient data for your solvent, not included in ICH Q3C?
In cases where high-quality data for your residual solvent is unavailable, the correct analogue – or class of analogues – needs to be identified. Where possible, we will provide appropriate read-across analogues and utilise the anologue/s to establish an acceptable intake (AI) for your residual solvent.

Do you need help evaluating the level of elemental impurities in your final drug product?
Elemental impurities (EIs) can originate from several sources and need to be controlled to a safe limit. It is important to evaluate each source to understand its contribution to overall EI levels in the final drug product. We can help you to assess the risk of EIs in your final drug product, relative to the permitted daily exposure (PDE), in line with the ICH Q3D guidance. If necessary, based on the risk assessment outcome, we can propose a control strategy.

Do you need support defining health based exposure limits?

When multiple medicinal products are manufactured in a shared facility, the risk of cross-contamination should be evaluated. We can provide a structured scientific evaluation of pharmacological and toxicological data to define a health based exposure limit for your product, considering the other products manufactured within the facility. The outcome will be a threshold value e.g. permitted daily exposure (PDE) or threshold of toxicological concern (TTC) .