FDA Analytical Procedures and Methods Validation for Drugs and Biologics

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1 Analytical Procedures and Methods Validation for Drugs and 2 Biologics 1

3 Guidance for Industry 4 5 6 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 7 this topic. It does not create any rights for any person and is not binding on FDA or the public. You can 8 use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To 9 discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title 10 page. 11 12 13 14 I. INTRODUCTION 15 16 This guidance supersedes the draft of the same name that published on February 19, 2014 (79 FR 17 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods 2,3

18 Validation and the 1987 Guidelines for Submitting Samples and Analytical Data for Methods 19 Validation. It provides recommendations on how you, the applicant, can submit analytical 4 5

20 procedures and methods validation data to support the documentation of the identity, strength, 6

21 quality, purity, and potency of drug substances and drug products. It will help you assemble 22 information and present data to support your analytical methodologies. The recommendations 23 apply to drug substances and drug products covered in new drug applications (NDAs), 24 abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and 25 supplements to these applications. The principles in this guidance also apply to drug substances 26 and drug products covered in Type II drug master files (DMFs). 27 28 This guidance complements the International Conference on Harmonisation (ICH) guidance 29 Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and 30 validating analytical methods. 31 32 This guidance does not address investigational new drug application (IND) methods validation, 33 but sponsors preparing INDs should consider the recommendations in this guidance. For INDs, 34 sufficient information is required at each phase of an investigation to ensure proper identity, 35 quality, purity, strength, and/or potency. The amount of information on analytical procedures 7

36 and methods suitability will vary with the phase of the investigation. For general guidance on 1

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

Sample submission is described in section IX, FDA Methods Verification. 3

We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 4

Analytical procedure is interchangeable with a method or test procedure. 5

Compendial methods are verified rather than validated as described in section VI, C. 6

The terms drug substance and drug product are used in this guidance to refer to both human drugs and biologics. 7

See 21 CFR 312.23(a)(7).

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