New Draft for a CPMP Guideline on Near Infrared Spectroscopy: NIRS in the Dossier for a Marketing Authorisation

GMP News No. 160

GMP News
9 January 2002
 

New Draft for a CPMP Guideline on Near Infrared Spectroscopy:
NIRS in the Dossier for a Marketing Authorisation

 
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

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