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

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 quantitavie analysis or in process analytical technology.

Keywords: Near infrared (NIR), near infrared spectroscopy (NIRS), process analytical technology (PAT)

Document history - Revision 2

Document history - Revision 1

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