Draft guidance was issued in March on the development and submission of near infrared (NIR) analytical procedures for use during the manufacture and analysis of pharmaceuticals. NIR is a spectroscopic technique that uses wavelengths of light just below the visible spectrum (typically between 700-800 nm) to measure materials for either identity or concentration. It’s been used successfully to test pharmaceutical raw materials, in-process materials and intermediates, and finished products, and methods for cGMP use require validation. The draft guidance also makes recommendations on how two other guidances may be applied:

Q2(R1): Validation of Analytical Procedures: Text and Methodology (ICH Q2(R1)); and

PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.

The draft guidance provides a nice outline for the development, validation, and submission of NIR procedures for at-line, off-line, in-line, and on-line use. There’s also a section outlining what constitutes a major, moderate, or minor change to an approved method (something that often confounds plans to update methods for approved products even when the update is clearly more scientifically sound than the original method). A nice feature is the sections on development, external validation, and use of chemometric models for spectral interpretation.

December 2021 update: The draft guidance was made final in August, 2021. You can find it at the link above.

Text Copyright © 2019 Katrina Rogers