ICH M7 provides greater flexibility to assess the risk posed by Mutagenic Impurities. This is described in section 8 – Control of the guideline and defined as a series of control options. Of these Option 4 permits an applicant to present an argument for control based on the physico-chemical properties of a mutagen and the processing conditions used in the manufacture of the API. This approach aligns to that published by Teasdale et al Org. Process Res. Dev. 2013, 17, 221−230. This sets out a systematic risk assessment tool, based on a standardised scoring system to quantitatively assess the risk of a mutagenic impurity carrying through at levels of concern into the final API. Cross referenced in ICH M7 and widely used and accepted by regulatory authorities, this approach, referred to as Purge factor calculations, can reduce the need for testing by over 80%.
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