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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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