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Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be forwarded in the Part II of the Dossier for a Marketing Authorisation
This guideline is intended to provide guidance in the process of calibration, validation and maintenance of a Near Infrared Spectroscopy (NIRS) method and the type of data to be submitted to the competent authorities in the case that NIRS is subject or part of an application.
