
[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Pages 44357-44358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18270]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0103]


Analytical Procedures and Methods Validation for Drugs and 
Biologics; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Analytical 
Procedures and Methods Validation for Drugs and Biologics.'' This 
guidance supersedes the draft of the same name that published on 
February 19, 2014, and replaces the 2000 draft guidance for industry on 
``Analytical Procedures and Methods Validation'' and the 1987 FDA 
guidance for industry on ``Submitting Samples and Analytical Data for 
Methods Validation.'' This guidance discusses how to 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.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Communications, Division of Drug Information, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10001 
New Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 
20993, or to the Office of Communication, Outreach and Development, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your requests. The guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lucinda Buhse, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2130, Silver Spring, MD 20993-0002, 240-
402-4595, or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Analytical Procedures and Methods Validation for Drugs and 
Biologics.'' This guidance supersedes the draft of the same name that 
published on February 19, 2014, and replaces the 2000 draft guidance 
for industry on ``Analytical Procedures and Methods Validation'' and 
the 1987 FDA guidance for industry on ``Submitting Samples and 
Analytical Data for Methods Validation.'' It discusses how to 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, and how to assemble information 
and present

[[Page 44358]]

data to support analytical methodologies. The recommendations in this 
guidance apply to new drug applications, abbreviated new drug 
applications, biologics license applications, and supplements to these 
applications. The principles in this guidance also apply to Type II 
drug master files. This guidance does not address investigational new 
drug application (IND) methods validation specifically, but the 
principles being discussed may be helpful to sponsors preparing INDs.
    This guidance complements the International Conference on 
Harmonisation guidance ``Q2(R1) Validation of Analytical Procedures: 
Text and Methodology.''
    In the Federal Register of February 19, 2014 (79 FR 9467), this 
guidance was published as a draft guidance. We have carefully reviewed 
and considered the comments that were received on the draft guidance 
and have made changes for clarification.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on analytical procedures and methods 
validation. 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.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 211, 21 CFR part 
314, and 21 CFR part 601 have been approved under OMB control numbers 
0910-0139, 0910-0001, and 0910-0338.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: July 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18270 Filed 7-24-15; 8:45 am]
BILLING CODE 4164-01-P


