Analytical Procedures and Methods Validation for Drugs
and Biologics
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.  Submit electronic comments to v.  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Registe r.
For questions regarding this draft document contact (CDER) Lucinda Buhse 314-539-2134, or (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301-827-1800.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
February 2014
CMC
Analytical Procedures and Methods Validation for Drugs
and Biologics
Additional copies are available from:
Office of Communications
Division of Drug Information, WO51, Room 2201
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Silver Spring, MD 20993
Phone: 301-796-3400; Fax: 301-847-8714
druginfo@v
v/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
Office of Communication, Outreach and
Development, HFM-40
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
ocod@v
v/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
(Tel) 800-835-4709 or 301-827-1800
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Febr uary 2014
CMC
TABLE OF CONTENTS
I.INTRODUCTION (1)
II.BACKGROUND (2)
III.ANALYTICAL METHODS DEVELOPMENT (3)
IV.CONTENT OF ANALYTICAL PROCEDURES (3)
A.Principle/Scope (4)
B.Apparatus/Equipment (4)
C.Operating Parameters (4)
D.Reagents/Standards (4)
E.Sample Preparation (4)
F.Standards Control Solution Preparation (5)
G.Procedure (5)
H.System Suitability (5)
I.Calculations (5)
J.Data Reporting (5)
V.REFERENCE STANDARDS AND MATERIALS (6)
VI.ANALYTICAL METHOD VALIDATION FOR NDA, ANDAs, BLAs, AND DMFs (6)
A.Noncompendial Analytical Procedures (6)
B.Validation Characteristics (7)
C.Compendial Analytical Procedures (8)
VII.STATISTICAL ANALYSIS AND MODELS (8)
A.Statistics (8)
B.Models (8)
VIII.LIFE CYCLE MANAGEMENT OF ANALYTICAL PROCEDURES (9)
A.Revalidation (9)
B.Analytical Method Comparability Studies (10)
1.Alternative Analytical Procedures (10)
2.Analytical Methods Transfer Studies (11)
C.Reporting Postmarketing Changes to an Approved NDA, ANDA, or BLA (11)
IX.FDA METHODS VERIFICATION (12)
X.REFERENCES (12)
Contains Nonbinding Recommendations
Draft — Not for Implementation
Guidance for Industry1
1
Analytical Procedures and Methods Validation for Drugs and
2
Biologics
3
4
5
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current 6
thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to 7
bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of 8
the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA
9
staff responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call 10
the appropriate number listed on the title page of this guidance.
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I. INTRODUCTION
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This revised draft guidance supersedes the 2000 draft guidance for industry on Analytical
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Procedures and Methods Validation2,3  and, when finalized, will also replace the 1987 FDA
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guidance for industry on Submitting Samples and Analytical Data for Methods Validation. It
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provides recommendations on how you, the applicant, can submit analytical procedures4 and
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methods validation data to support the documentation of the identity, strength, quality, purity,
21
and potency of drug substances and drug products.5It will help you assemble information and 22
present data to support your analytical methodologies.  The recommendations apply to drug
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substances and drug products covered in new drug applications (NDAs), abbreviated new drug 24
applications (ANDAs), biologics license applications (BLAs), and supplements to these
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submitting
applications.  The principles in this revised draft guidance also apply to drug substances and drug 26
products covered in Type II drug master files (DMFs).
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This revised draft guidance complements the International Conference on Harmonisation (ICH) 29
guidance Q2(R1)Validation of Analytical Procedures:  Text and Methodology(Q2(R1)) for
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developing and validating analytical methods.
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This revised draft guidance does not address investigational new drug application (IND) methods 33
validation, but sponsors preparing INDs should consider the recommendations in this guidance.
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For INDs, sufficient information is required at each phase of an investigation to ensure proper
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identity, quality, purity, strength, and/or potency.  The amount of information on analytical
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procedures and methods validation will vary with the phase of the investigation.6  For general
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1 This guidance has been prepared by the Office of Pharmaceutical Science, 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
v/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
4Analytical procedure is interchangeable with a method or test procedure.
5The terms drug substance and drug product, as used in this guidance, refer to human drugs and biologics.
6 See 21 CFR 312.23(a)(7).

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