Application Note: Tracking fate and purge of impurities and calculating carryover

The purpose of process development in pharma is to select and optimise a synthetic route to produce the active pharmaceutical ingredient (API) by the safest, cheapest, fastest, and cleanest (by green chemistry where possible) route, following both Good Laboratory Practice (GLP) and Quality by Design (QbD) principles.

As with any synthetic process impurities are generated, and for API development it is mandated by regulatory authorities (e.g., Federal Drug Agency—FDA, European Medicines Agency— EMA, etc.) that impurities are tracked and identified above a certain threshold, while genotoxic and mutagenic impurities must be reported at any level (as stated in the ICH Q7 guideline¹).

Route scouting data, in process development, is typically stored in electronic notebooks. Associated analytical information may be accessible as PDF images stored within an experiment record. Unfortunately, however, from the perspective of entity characterisation and review, the analytical data is not dynamically linked with the individual stage(s) of the process route and is unsearchable and inaccessible.