FDA Development and Submission of Near Infrared Analytical Procedures

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Development and Submission of Near Infrared Analytical Procedures 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files. FDA intends to issue recommendations specific to NIR methods used for biological products under biologics license applications in a future revision to this guidance. This guidance provides recommendations to applicants for applying the concepts described in the guidance for industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (September 2004) (PAT guidance) and the International Council for Harmonisation (ICH) guidance for industry Q2(R1) Validation of Analytical Procedures: Text and Methodology 2 3

(November 2005) to NIR analytical procedures that use chemometric models. This guidance 4

also provides recommendations for submitting NIR documentation in applications. 1

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

In November 2005, the ICH incorporated both the ICH guidance for industry Q2A Text on Validation of Analytical Procedures and the ICH guidance for industry Q2B Validation of Analytical Procedures: Methodology into ICH Q2(R1). Although the FDA guidance web page separately lists ICH Q2A and ICH Q2B, any references to ICH Q2(R1) in this guidance, unless otherwise indicated, refer to both ICH Q2A and ICH Q2B. 3

We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 4

This guidance contains technical and scientific recommendations that may be useful during development of NIR-

based analytical procedures for nonprescription drugs to which the application submission recommendations in this guidance do not apply.

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