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 CPMPGuideline on Near Infrared Spectroscopy:
NIRS in the Dossier for aMarketing Authorisation

On 14 November 2001, EMEA published a draft of the "Note for Guidanceon the Use of Near Infrared Spectroscopy by the Pharmaceutical Industryand the Data to be Forwarded in Part II of the Dossier for a MarketingAuthorisation".

With this guideline, requirements havebeen formulated on the necessary data that have to be presented to thecompetent authorities in the dossier when applying for the approval of aNIRS (Near Infrared Spectroscopy) method.

Even though NIRS is listed as a Monographin the European Pharmacopoeia, the CPMP emphasises that a mere referenceto this Monograph is not sufficient!

NIRS can be applied as an alternative toone or several methods which are listed in the dossier for a marketingauthorisation (Part II), the so-called reference methods. Since NIRS canonly be developed with the help of these reference methods and cannoteasily be repeated by the official control laboratories, the referencemethods and the corresponding specifications always have to be mentionedin the dossier additionally.

An example: in the identification ofstarting materials that are mentioned in the Pharmacopoeia it has to beindicated exactly which of the identity tests of a PharmacopoeialMonograph are replaced by the NIRS test.

The Guideline recommends that once a yearor every 10th batch a sample of a batch should be analysed by means ofboth methods and the results should be compared.

The CPMP draft differentiates betweenqualitative and quantitative NIRS methods and sets out the following itemsfor each of the two procedures:

-General remarks

-Method development

-Method validation

-Change control and transferability

The four chapters are followed by atwo-page-long table listing the data that are to be forwarded in Part IIof the dossier for a marketing authorisation of a NIRS method.

Comments on this draft can be sent toEMEA until May 2002.

You can find this draft with the codeEMEA/CVMP/961/01 or CPMP/QWP/3309/01 draft on the EMEA homepage (

Writer: Dr Günter Brendelberger, CONCEPT HEIDELBERG




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