New EMA draft on NIRS

Recommendation

26-28 October 2021

Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products - Live Online

Near Infrared Spectroscopy (NIRS) is one of the most important technologies used in Process Analytical Technology (PAT) processes. NIRS can also be part of Real Time Release Testing (RTRT) strategies. NIRS used as PAT tool underlines the principles of Quality by Design (QbD).

The EMA has published the draft of the "Guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations" in January 2012. This document contains requirements concerning the development, calibration, validation and maintenance of NIRS methods. It refers especially to marketing authorisation applications and variation applications.

Right at the beginning, the important key terms "NIRS method", "NIRS model" and "NIRS procedure" are defined.

NIRS is not generally used as a primary analytical method. NIRS procedures are developed and validated instead in conjunction with a reference method. But if NIRS is used for PAT processes it may not be possible to refer to a conventional reference method.

Find below the main stages in implementing a NIRS procedure:

• Development 
• Data collection and interpretation 
• Calibration 
• Validation 
• Maintenance

This is followed by detailed indications on the general requirements and on the qualitative and quantitative procedures.

The new European requirements concerning NIRS will also be presented at the QbD/PAT Conference of the University Heidelberg in Heidelberg on 26 and 27 September 2012. Prof. Karl Molt of the University of Duisburg-Essen will show the aspects that are relevant in practice and in theory and discuss their impact.

For further information please see the draft of the "Guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations".

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