Pharmaceutical Technology Europe-02-01-2005

Pharmaceutical Technology Europe

Monitoring Granulation Drying Using Near-Infrared Spectroscopy

February 01, 2005

PAT

17

2

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

February 01, 2005

Process Planning

17

2

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

February 01, 2005

GXP

17

2

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

February 01, 2005

Talking Point

17

2

A look at how process analytical technology promises to be the most radical change in pharmaceutical manufacturing in 30 years...

Documentary Evidence

February 01, 2005

QA/QC

17

2

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...