Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations - Scientific guideline
This guideline applies to both human and veterinary medicines.
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 quantitative analysis or in process analytical technology.
Keywords: Near infrared (NIR), near infrared spectroscopy (NIRS), process analytical technology (PAT)
The "Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations” introduced the concept of the NIRS procedure scope. An addendum was published in 2014 to exemplify the scope and how changes should be reported to EU regulatory authorities. Based on experience of regulators to date, it is proposed to amend this addendum, to facilitate continuous improvement and lifecycle management of NIRS procedures.
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Guideline on the use of near-infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations (PDF/333.83 KB)
Adopted
First published: 05/06/2014
Last updated: 05/06/2014
Legal effective date: 06/12/2014
EMEA/CHMP/CVMP/QWP/17760/2009 Rev2 -
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Overview of comments received on guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations draft revision 2 (PDF/512.92 KB)
First published: 05/06/2014
Last updated: 05/06/2014
EMA/CHMP/CVMP/QWP/63698/2014 -
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Draft guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations - Revision 2 (PDF/207.76 KB)
Draft: consultation closed
First published: 09/02/2012
Last updated: 09/02/2012
Consultation dates: 12/01/2012 to 31/05/2012
EMEA/CHMP/CVMP/QWP/17760/2009
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Overview of comments received on ‘guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations’ - Revision 1 (PDF/69.21 KB)
First published: 09/02/2012
Last updated: 09/02/2012
EMA/CHMP/CVMP/QWP/989848/2011 -
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Draft guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations - Revision 1 (PDF/258.97 KB)
Draft: consultation closed
First published: 16/02/2009
Last updated: 16/02/2009
EMEA/CHMP/CVMP/QWP/17760/2009 -
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Concept paper on revision of the note for guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations (PDF/141.87 KB)
First published: 27/06/2006
Last updated: 27/06/2006
EMEA/CHMP/CVMP/QWP/173698/2006