|
On 14 November 2001, EMEA published a draft of the "Note for Guidance
on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry
and the Data to be Forwarded in Part II of the Dossier for a Marketing
Authorisation".
With this guideline, requirements have
been formulated on the necessary data that have to be presented to the
competent authorities in the dossier when applying for the approval of a
NIRS (Near Infrared Spectroscopy) method.
Even though NIRS is listed as a Monograph
in the European Pharmacopoeia, the CPMP emphasises that a mere reference
to this Monograph is not sufficient!
NIRS can be applied as an alternative to
one or several methods which are listed in the dossier for a marketing
authorisation (Part II), the so-called reference methods. Since NIRS can
only be developed with the help of these reference methods and cannot
easily be repeated by the official control laboratories, the reference
methods and the corresponding specifications always have to be mentioned
in the dossier additionally.
An example: in the identification of
starting materials that are mentioned in the Pharmacopoeia it has to be
indicated exactly which of the identity tests of a Pharmacopoeial
Monograph are replaced by the NIRS test.
The Guideline recommends that once a year
or every 10th batch a sample of a batch should be analysed by means of
both methods and the results should be compared.
The CPMP draft differentiates between
qualitative and quantitative NIRS methods and sets out the following items
for each of the two procedures:
-
General remarks
-
Method development
-
Method validation
-
Change control and transferability
The four chapters are followed by a
two-page-long table listing the data that are to be forwarded in Part II
of the dossier for a marketing authorisation of a NIRS method.
Comments on this draft can be sent to
EMEA until May 2002.
You can find this draft with the code
EMEA/CVMP/961/01 or CPMP/QWP/3309/01 draft on the EMEA homepage (http://www.emea.eu.int/).
Writer: Dr Günter Brendelberger, CONCEPT HEIDELBERG
Are you working in a quality-control lab
in the pharmaceutical or API industry?
Click
here to get more information about how to obtain the ECA Certified
Quality Control Manager qualification.
|
