Introduction:

This guidance supersedes thedraft of the same name that published on February 19, 2014 (79 FR 9467) andreplaces the 2000 draft guidance for industry on Analytical Procedures and MethodsValidation and the 1987 Guidelines for Submitting Samples and Analytical Datafor Methods  Validation. It provides recommendations on how you, theapplicant, can submit analytical procedures and methods validation data tosupport the documentation of the identity, strength, quality, purity, andpotency of drug substances and drug products. It willhelp you assemble information and present data to support your analyticalmethodologies. The recommendations apply to drug substances and drug productscovered in new drug applications (NDAs), abbreviated new drug applications(ANDAs), biologics license applications (BLAs), and supplementsto these applications. The principles in this guidance also apply to drugsubstances and drug products covered in Type II drug master files (DMFs).

This guidance complements the InternationalConference on Harmonisation (ICH) guidance Q2(R1)Validation of Analytical Procedures: Text and Methodology (Q2(R1))for developing and validating analytical methods.  

Thisguidance does not address investigational new drug application (IND) methods validation,but sponsors preparing INDs should consider the recommendations in thisguidance.

Background:

Analytical proceduresverification or validation data should be submitted in the correspondingsections of the application in the ICH M2 eCTD: Electronic Common TechnicalDocument Specification.

Whenan analytical procedure is approved/licensed as part of the NDA, ANDA, or BLA,it becomes the FDA-approved analytical procedure for the approved product. Thisanalytical procedure may originate from FDA recognized sources (e.g., acompendial procedure from the United States Pharmacopeia/National Formulary (USP/NF)) or avalidated procedure you submitted that was determined to be acceptable by FDA.To apply an analytical method to a different drug product, appropriatevalidation or verification studies for compendial procedures with the matrix ofthe new product should be considered.

Recommendations:

Guidanceincludes recommendations on

·       Analytical methods development

·       Content of analytical procedures 

·       Reference standards and materials

·       Analytical method validation

·       Statistical analysis and models

·       Life cycle management of analytical procedures

·       FDA methods verification

Final Guidance: Analytical Procedures and Methods Validation for Drugs andBiologics (PDF - 134KB)