Module 3 2019

Drug Substance Impurities Other Impurities

Some separative techniques for impurities can be treated with very similar validation approaches (e.g. GC, IC, CE) ● Limit tests require less validation parameters to be validated (see ICH Q2 (R1)) ● Trace Analysis may need validation or verification ‘in use’ ● Others (e.g. Water ) need some adaptation

– To show lack of side reactions/interference – Optimise extraction and titration conditions

Currently under discussion: ICH Q2(R2)/Q12 – to include spectroscopic and spectrometric data/techniques

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