The US Food and Drug Administration (FDA) has issued final guidance, Analytical Procedures and Methods Validation for Drugs and Biologics, to provide recommendations on how applicants of various regulatory filings can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. The guidance provides recommendations to applicants on how information and data should be presented to support analytical methodologies.
The recommendations apply to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files (DMFs).
The guidance supersedes the draft of the same name that was published on February 19, 2014 and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and the 1987 Guidelines for Submitting Samples and Analytical Data for Methods Validation. The guidance complements the International Conference on Harmonization (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and
validating analytical methods. This guidance does not address investigational new drug application (IND) methods validation, but sponsors preparing INDs should consider the recommendations in this guidance. The FDA said that for INDs, sufficient information is required at each phase of an investigation to ensure proper identity, quality, purity, strength, and/or potency. The amount of information on analytical procedures and methods suitability will vary with the phase of the investigation.