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.