CPMP Guideline on NIR Adopted

GMP News No. 316

GMP News
16 June 2003

CPMPGuideline on NIR Adopted

The "Note for Guidance on the Use of NearInfrared Spectroscopy by the Pharmaceutical Industry and the DataRequirements for New Submissions and Variations" was adopted by theCPMP/CVMP Quality Working Party in February 2003 and now published by EMEAwith the date of 20 February 2003.

This Guideline is meant to give supportto the industry regarding the calibration and validation in theimplementation of Near Infrared Spectroscopy (NIR) and, above all, toshow which data have to be submitted to the registration authorities whenusing NIR methods.

This recently adopted Guideline, whichwill come into force in August 2003, is structured like the former draftof November 2001. However, compared to the draft, almost all paragraphs ofthe Guideline have been modified as to their form and content - except forthe virtually unchanged introduction.

What has also been revised are the listsof data items that have to be handed in together with the dossier for amarketing authorisation or a variation application.

You can find the unabridged CPMPGuideline onthe Internet at:

Dr Günter Brendelberger


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