Module 3 Presentations

07/05/2024

Drug Substance Impurities Consideration of Linear Range

A suitable Linear Range should be validated which will be suitable throughout the development and (at least some of) the commercial lifecycle of the drug substance

The Organisation for Professionals in Regulatory Affairs

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Drug Substance Impurities Other Impurities

Some separative techniques for impurities can be treated with very similar validation approaches (e.g. GC) ● Limit tests require less validation parameters to be validated (see ICH Q2 (R1)) ● Trace Analysis may need validation or verification

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

The Organisation for Professionals in Regulatory Affairs

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