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)

Current effective version

Guideline on the use of near-infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations

Adopted Reference Number: EMEA/CHMP/CVMP/QWP/17760/2009 Rev2 Legal effective date: 06/12/2014

Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure

Draft: consultation closed Reference Number: EMA/CHMP/CVMP/QWP/17760/2009 Rev 3 Legal effective date: 02/05/2024

Revision 3

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.

Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure

Draft: consultation closed Consultation dates: 10/11/2023 to 22/12/2023 Reference Number: EMA/CHMP/CVMP/QWP/17760/2009 Summary:

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.

Overview of comments received on Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure

Reference Number: EMA/101673/2024

Document history - Revision 2

Guideline on the use of near-infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations

Adopted Reference Number: EMEA/CHMP/CVMP/QWP/17760/2009 Rev2 Legal effective date: 06/12/2014

Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 2: Defining the Scope of an NIRS Procedure

Reference Number: EMA/CHMP/CVMP/QWP/63699/2014

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

Reference Number: EMA/CHMP/CVMP/QWP/63698/2014

Draft guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations - Revision 2

Draft: consultation closed Consultation dates: 12/01/2012 to 31/05/2012 Reference Number: EMEA/CHMP/CVMP/QWP/17760/2009 Summary:

Near Infrared Spectroscopy (NIRS) is a technique, usually requiring tandem chemometric statistics, with a wide and varied use in pharmaceutical, chemical, physical and process analysis. This includes identification, qualification and assay of pharmaceutical starting materials, intermediates and finished products and verification of physicochemical properties.

Document history - Revision 1

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

Reference Number: EMA/CHMP/CVMP/QWP/989848/2011 Summary:

The guideline on the use of Near Infra Red Spectroscopy was published for public consultation in 2009 (Doc. Ref: EMEA/CHMP/CVMP/QWP/17760/2009 Rev1).

Draft guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations - Revision 1

Draft: consultation closed Reference Number: EMEA/CHMP/CVMP/QWP/17760/2009

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

Reference Number: EMEA/CHMP/CVMP/QWP/173698/2006

Document history - First version

Note for guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations

Adopted Reference Number: CPMP/QWP/ 3309/01 Legal effective date: 01/08/2003