Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations

Current effective version

PDF iconRevision 2 - Adopted guideline

PDF iconAddendum

Reference number EMEA/CHMP/CVMP/QWP/17760/2009 Rev. 2
Published 05/06/2014
Effective from 06/12/2014
Keywords Near infrared (NIR), near infrared spectroscopy (NIRS), process analytical technology (PAT)
Description This document provides guidance on the use of near infrared spectroscopy (NIRS) procedures. It outlines requirements for the applications in which NIRS is used for qualitative and quantitavie analysis or in process analytical technology.

Document history

Revision 2

Current version

PDF iconAdopted guideline


PDF iconAddendum


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 06/12/2014–present


Published: 05/06/2014


Published: 05/06/2014


Published: 09/02/2012

Revision 1

PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

Published: 09/12/2012


Published: 16/02/2009


Published: 27/06/2006

First version PDF iconAdopted guideline

In operation: 01/08/2003–06/12/2014

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