FDA Outlines Policy on Use of Near Infrared Analysis to Test Drug Quality

New guidance issued by the US Food and Drug Administration (FDA) is intended to help pharmaceutical companies use near infrared (NIR) technology to better ensure the quality of their manufactured drug products.

Background

The draft guidance, Development and Submission of Near Infrared Analytical Procedures, is focused on NIR analytical procedures, which are used to identify pharmaceutical starting materials, unfinished drugs and finished pharmaceutical products. NIR technology measures a chemical's absorption of infrared wavelengths to determine if a product has been made correctly and with the correct ingredients without necessarily requiring the physical destruction of a sample.

While the use of NIR technology isn't new, FDA's draft guidance explained that it is "increasingly being used in the pharmaceutical industry" to test the quality of pharmaceutical products.

"The development and validation of NIR analytical procedures are therefore important for ensuring the quality of pharmaceuticals. It is important for manufacturers who use such procedures to understand the factors that can affect the performance and suitability of the procedures and the approaches that can be used to validate them," FDA wrote.

FDA, as well as other global regulators, have long maintained that any analytical procedures used to test a product to ensure its quality need to be validated as accurate and reliable for each pharmaceutical product on which they are used. The validation process itself mostly covered by an international regulation, the International Conference on Harmonisation's (ICH) Q2(R1) Validation of Analytical Procedures: Text and Methodology.

New Guidance

But as FDA explains in its latest guidance, "Although many of the concepts described in ICH Q2(R1) can apply in general to a wide variety of analytical methodologies, the ICH guidance does not address some unique characteristics of NIR analytical procedures."

For example, FDA's guidance explains that companies must account for the contextual use of NIR testing. Some companies may employ "off-line" testing, in which a product or sample is "analyzed away from the [manufacturing] process stream or reactor." Other companies may sample a product in close proximity to the production line ("at-line"), while other companies may sample a product while it is still on the production line ("on-line" or "in-line" testing).

The location of testing will determine the needs of the NIR analysis, FDA notes in the guidance. For example, on-line NIR testing will likely require a "specialized analyzer and custom built interface to provide an acceptable signal-to-noise ratio and spectral acquisition time," FDA wrote. Companies will need to pay attention to the interface, spectral acquisition, data collection, sampling and reference measurements used in their NIR testing, the guidance adds.

FDA also advises companies to construct a "calibration set" to "mimic as closely as possible the samples that are expected from the commercial process. This set should take into account potential sources of variability, including environmental variability.

NIR analytical data should also be included in application for approval (or post-approval changes) to FDA, regulators said, including information on the NIR analytical procedure, and the development and validation of the NIR analytical procedure.

Development and Submission of Near Infrared Analytical Procedures (FR)