Revision of the General Chapter NIR in PHARMEUROPA

A revised version of General Chapter 2.2.40 - Near-Infrared Spectroscopy has been published in the PHARMEUROPA issue from July 2011.

The primary objective of this revision is the introduction of PAT concepts (PAT = Process Analytical Technology). During the revision process, attention was paid to avoid overlaps with the current revision of the EMA "Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations". For this reason, the sections about validation, data transfer and data storage have been removed from the Ph.Eur.-Chapter.

Instead, sections have been added regarding following points: 

• A detailed chart for control of instrument performance 
• Direct comparison of substance and reference spectra
• Relative comparison of spectra
• Trend Analysis 

The revised chapter deals with NIR measurements which can be performed off-line, at-line, in-line and on-line for PAT applications. Here are some possible examples of the application of NIR in process analysis: monitoring of API synthesis, crystallisation, blending, drying, granulation and coating.

Learn how to apply NIR and PAT during the QbD/PAT Conference of the University of Heidelberg on 5 - 7 October 2011 in Heidelberg. More information at:

Author:
Dr Günter Brendelberger
CONCEPT HEIDLEBERG (a service provider entrusted by the ECA Foundation)