European Medicinal Agency (EMA), Committee for Human Medicinal Products (CHMP), Committee for Veterinary Medicinal Products (CVMP
"This document provides guidance on the development, calibration, validation and maintanace of NIRS procedures, when used with chemometic statistics and when used for direct process monitoring.
NIRS is not a "primary" analytical method, its models have been qualified by reference analytical method, using analytical reference standards.
It is recognised that the development and implementation of an NIRS procedure is iterative and that the stages are interdependent.
NIRS differs from conventional analytical techniques such as HPLC or GC because chemometric techniques are generally required for the interpretation of the analyte signal.
This guideline outlines the requiements the requirements for applications in which NIRS isused for qualitative and quantitative analysis or whre it is used as a process analytical technology(PAT) for controlling and monitoring drug substance synthesis and finished product manufacturing processes.
Approaches other than those described in this guidance may be used, if appropriately explained and justified."
Die IETC 65 - Chemometrics for Process Instrumentation sollte "die Mindestanforderungen für spezifische Anwendungsfelder der Chemometrie beschreiben, z. B. für die Gerätequalifizierung, für die Kalibrierung und für die Analyse von unbekannten Proben".