On March 31, 2015 FDA announced the availability of a draft guidance for industry, Development and Submission of Near Infrared Analytical Procedures. The FR announcement states that comments are due to the agency by June 1, 2015. The 24-page draft guidance addresses the development and validation of NIR analytical procedures and states that the concepts in the guidance may be applied to other PAT technologies. The guidance does not address the set-up, calibration and maintenance of these instruments. The guidance applies to NDA, ANDA and DMF holders. While the guidance itself mentions used of NIR in the analysis of raw materials, it is not clear whether this applies to raw materials used in the manufacture of a product that is the subject of a BLA. While it would be reasonable to assume the concepts apply, they are not specifically called out in the scope of the guidance. The document also addresses how the concepts in ICHQ2 (R1) and FDA’s guidance on PAT may be applied to the development, validation and submission of NIR analytical procedures. For companies that sell product in Europe and need to satisfy requirements other than those of the FDA, the EMA finalized a similar guidance dated January 27, 2014, with an addendum dated June 5, 2014. The title of that guideline is: Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations. Briefly, the document addresses:
o Modes of Measurement, either at-line or off-line;
o Development of NIR Models including: construction of a calibration set, sample preparation, internal validation of quantitative calibration models / internal libraries, and rate of change models;
o External Validation of NIR Analytical Procedures including both qualitative and quantitative analytical procedures and rate of change models;
o Implementing and Maintaining the Analytical Procedures;
o Information to be submitted in the application;
o Post approval change reporting;
o An extensive glossary.