Spring Intro 2023

28/03/2023

3.2.S.3 Characterisation (contd)

3.2.S.3.2 Impurities

• Include structural characterisation data and summary of method of preparation here

• Include qualified level of each impurity, with cross reference to supporting non clinical studies

• Include data on observed level of impurities for relevant batches (particularly if impurity is not included in the specification)

The Organisation for Professionals in Regulatory Affairs

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3.2.S.3.2 Impurities (Mutagenic)

ICH M7 (aka ‘genotoxic impurities’) ● Guidance June 2014 ● Guidance well-aligned with current guidance and practice ● Applies to small molecule NCEs and small molecule components of bios ● Applies across lifecycle ● Applies to existing products (change management and known mutagenic materials) ● Durational limits for commercial products

The Organisation for Professionals in Regulatory Affairs

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