The agency outlines recommendations for the development and submission of near infrared analytical procedures.
FDA has issued guidance detailing the agency’s recommendations for the development and submission of near infrared (NIR) analytical procedures. Also included in the guidance are recommendations for how to apply concepts from International Conference on Harmonization (ICH) Q2(R1) Validation of Analytical Procedures: Text and Methodology and PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
According to FDA, the recommendations in the guidance can be applied to other process analytical technologies including Raman, focused beam reflection measurement, particle imaging, and X-ray. The guidance, however, states that it only “pertains to the development and validation of NIR analytical procedures” and does not address set up, qualification, maintenance, or calibration of NIR instruments.