CPMP Guideline on NIR Adopted

GMP News No. 316

GMP News
16 June 2003
 

CPMP Guideline on NIR Adopted

 
The "Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations" was adopted by the CPMP/CVMP Quality Working Party in February 2003 and now published by EMEA with the date of 20 February 2003.

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 Guideline on the Internet at:
http://www.emea.eu.int/pdfs/human/qwp/330901en.pdf

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
  

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