(401f) Near Infrared Spectroscopy (NIRS): An Enabling Tool for Pharmaceutical Quality by Design (QbD)

Authors: 
Wu, K. G., Food and Drug Administration
Christensen, L. V., Food and Drug Administration
Lionberger, R. A., Food and Drug Administration
Yu, L. X., Food and Drug Administration
Patankar, S., Food and Drug Administration

                                     Near Infrared Spectroscopy (NIRS): An Enabling Tool for Pharmaceutical Quality by Design (QbD)

K. Geoffrey Wu, Suhas Patankar, Lane V. Christensen, Robert A. Lionberger, Lawrence X. Yu

Office of Generic Drugs,  Food and Drug Administration,  Rockville, MD 20855

This presentation will provide an overview of the application of NIRS within the paradigm of pharmaceutical QbD and elaborate on the current thinking of the Office of Generic Drugs (OGD) regarding the deployment of such a useful application of process analytical technology (PAT).

Applying various types of NIRS methods for pharmaceutical development has been proposed by the generic industry to OGD.  Case studies will be given to demonstrate some of the major technical issues observed during the review of these proposals.  Such issues may be related to the NIR method development and validation, model maintenance, and parallel testing.  Points to consider during the model transfer (e.g., from R&D to manufacturing phase) will also be discussed.   

OGD encourages the use of NIRS and considers it as an important tool to facilitate the implementation of pharmaceutical QbD.  From OGD’s perspective, possible regulatory pathways to file the use of NIRS will be presented.