EMEA issues new Draft regarding NIRS

On February 16 2009 the European Medicines Agency (EMEA) issued the document "Guideline on the Use of Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations" as draft.

Subsequent to its completion, this guideline is supposed to replace the present Note for Guidance for applying NIR from 2001.

By now Near Infrared Spectroscopy (NIRS) is a frequently used method also in the pharmaceutical industry. Moreover, it is also one of the most important methods for PAT (Process Analytical Technology).

The Guideline covers development, calibration, validation and maintenance of NIRS methods and also addresses the data that need to be submitted to the authorities if the use of NIRS is mentioned in the application for authorisation.

Usually, NIRS is used as an alternative for a validated conventional method. This "reference method" also needs to be mentioned in the application dossier. The new EMEA guideline specifically emphasises the risk that the statistical possibilities of current NIRS software allows to develop NIRS methods even with a very limited understanding of chemometry. Consequently there is a high risk that due to the influence of undetected hidden variables the methods will show invalid results. With regard to GMP inspections it is therefore important to pay special attention to the qualification of personnel dealing with NIRS.

Important topics in the guideline draft are:

  • Development of the methods
  • Data collection
  • Calibration and selection of an appropriate calibration model
  • Change Control and maintenance
  • Validation
  • Qualitative methods
  • Quantitative methods
  • Application requirements

This new guideline is explicitly not valid for use of NIRS with regard to the identification of packages in the incoming goods inspection. This use is only relevant for GMP purposes!

Please see the complete draft for further information.

Comments can be submitted until 31 August 2009.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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