GMP News No. 316
16 June 2003
CPMP Guideline on NIR Adopted
This Guideline is meant to give support to the industry regarding the calibration and validation in the implementation of Near Infrared Spectroscopy (NIR) and, above all, to show which data have to be submitted to the registration authorities when using NIR methods.
This recently adopted Guideline, which will come into force in August 2003, is structured like the former draft of November 2001. However, compared to the draft, almost all paragraphs of the Guideline have been modified as to their form and content - except for the virtually unchanged introduction.
What has also been revised are the lists of data items that have to be handed in together with the dossier for a marketing authorisation or a variation application.
This guideline will be presented and discussed at the International Conference on Near Infrared Spectroscopy with the collaboration of the University of Heidelberg. The Conference, which takes place in Heidelberg, Germany, on 17-18 September 2003, will be followed by a Post-conference Workshop on FDA's PAT Initiative on 19 September. If you would like to read the complete invitation programme, please click here.
You can find the unabridged CPMP
the Internet at: