14/15 September 2021
Near Infrared Spectroscopy (NIRS) is one of the key technologies applied in PAT (Process Analytical Technology) processes. NIRS can also be part of "Real Time Release Testing (RTRT)" strategies. Since the application of NIRS requires an understanding of the products and processes, it is widely used in Quality by Design (QbD) approaches.
In January 2014 the EMA now published the final "Guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations". This document contains requirements for the development, calibration, and validation of NIRS methods, both for qualitative and quantitative analyses. And it also applies to PAT applications.
The guideline specifically also refers to the submission of NIRS methods or to variations to approved methods.
In addition, the EMA has published an addendum to this guideline on 5 June 2014 to clarify the scope of application of the guideline. In this addendum it is stated: Changes within the approved scope of the NIRS method are only subject to GMP. Changes outside of the approved scope of the NIRS method are subject to the rules of variation.
The addendum was intentionally created in addition to introduce a fictitious example to show how changes are supposed to be handled in accordance with this guideline. A NIRS method for the release testing of an active substance in a finished product (assay and content uniformity in a tablet) is used as an example. For this example, table 2 lists the changes within the scope of approved NIRS methods. Table 3 shows changes that are outside the approved scope.
PS: This new European Guideline with regard to NIRS will also be discussed a the University of Heidelberg QbD/PAT Conference on 15 and 16 October 2014 in Heidelberg.