Monitoring Granulation Drying Using Near-Infrared Spectroscopy
A novel probe design that reduces the variation in powder-sample density also allows moisture and solvent levels to be accurately modelled and predicted...
Process Considerations During API Development
This article looks at how to adopt a systematic and prospective approach in the API development process to achieve documented, controlled synthetic processes...
The Introduction of GMP for APIs in the European Union
European Directive 2004/27/EC will have massive repercussions on the manufacture and marketing of APIs and some excipients across Europe...
Times They Are A-changing
A look at how process analytical technology promises to be the most radical change in pharmaceutical manufacturing in 30 years...
Documentary Evidence
A look at the role of document management in the product life-cycle and how this can lead to the effective use of CTDs and e-CTDs when compiling compulsory regulatory submissions...
