The FDA has released a Draft Guidance entitled, “Development and Submission of Near Infrared Analytical Procedures – Guidance for Industry,” which covers the development, validation, and submission of NIR analytical methods. The Agency recognizes that NIR analytical procedures are used extensively for the identification and assay of pharmaceutical starting materials, intermediates, finished products, and for the monitoring and control manufacturing processes as a process analyzer (a form of process analytical technology [PAT]). However, the unique nature of NIR spectroscopic methods has resulted in this specific Guidance, which builds upon ICHQ2 (R1) Validation of Analytical Procedures: Text and Methodology. Guidance is provided for both qualitative and quantitative NIR procedures in the potential different PAT modes: Off-Line, At-Line, On-Line, and In-line. Even though this Guidance is written specifically for NIR procedures, it is recognized that this Guidance could apply to other PAT spectroscopic techniques, such as Raman, X-ray, etc.
The Guidance provides considerations and design recommendations for the development and validation of robust NIR quantitative, qualitative, or rate of change (e.g., blending, drying) methods. The areas of focus are: development of the specific NIR model (based upon chemometrics and the establishment of calibration samples); understanding the sources and consideration of the methods expected variability; experimental guidance for method validation and method maintenance throughout the product lifecycle.
Specific instructions are included within the Guidance for regulatory application content in relation to method development and validation. In addition, the Guidance provides recommendations for the reporting of post-approval changes.
For any questions you may have on the application of this guidance or assistance in utilization of NIR in your facility, please contact Paul Mason (firstname.lastname@example.org).