Rx-360 Summary of FDA Draft Guidance for Industry, Development and Submission of Near Infrared Analytical Procedures

Rx-360 has produced a summary of FDA's draft guidance for industry, Development and Submission of Near Infrared Analytical Procedures.

Near infrared (NIR) analytical procedures are increasingly being used in the pharmaceutical industry for the identification and assay of pharmaceutical starting materials, intermediates and finished products. They are also used to monitor and control manufacturing processes. 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.

This guidance provides recommendations to applicants of new drug applications (NDAs), abbreviated new drug applications (ANDAs) and drug master file (DMF) holders regarding the development and submission of NIR analytical procedures used during the manufacture and analysis of pharmaceuticals (including raw materials, in-process materials and intermediates, and finished products). It also provides recommendations regarding how the concepts described in the International Conference on Harmonization (ICH) guidance for industry Q2(R1) Validation of Analytical Procedures: Text and Methodology (ICH Q2(R1)) and PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance can be applied to the development, validation, and submission of NIR analytical procedures.

This guidance only pertains to the development and validation of NIR analytical procedures and does not provide recommendations concerning the set-up and qualification of NIR instruments or their maintenance and calibration. Although this guidance is written specifically for NIR, the fundamental concepts of validation can be applied to other PAT technologies including Raman, focused beam reflection measurement, particle imaging, X-ray, among other techniques.

Comments on the draft guidance are due by 1 June 2015.