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.
The rest of this content is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!
Related content from this organisation
- On-demand webinar: Reduce your time investment in impurity data management
- On-demand webinar: Practical considerations for improving high throughput synthesis
- Case study: Better, faster method development at Janssen Pharmaceutical Companies of Johnson & Johnson
- Under the microscope: Mitigating risks in manufacturing processes
- Application note: A CMC Development Decision Support Tool for Batch Genealogy Management