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

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Current effective version

Revision 2 - Adopted guideline

Addendum

Reference numberEMEA/CHMP/CVMP/QWP/17760/2009 Rev. 2
Published05/06/2014
Effective from06/12/2014
KeywordsNear infrared (NIR), near infrared spectroscopy (NIRS), process analytical technology (PAT)
DescriptionThis 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

Adopted guideline


Addendum


Overview of comments


Draft guideline

In operation: 06/12/2014–present


Published: 05/06/2014


Published: 05/06/2014


Published: 09/02/2012

Revision 1
 

Overview of comments


Draft guideline


Concept paper

Published: 09/12/2012


Published: 16/02/2009


Published: 27/06/2006

First versionAdopted guideline

In operation: 01/08/2003–06/12/2014


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