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
Title:
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
Short Title:
CPMP/QWP/3309/01
Origin/Publisher:
EMEA
Document Type:
CPMP Note for Guidance
Content:
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.