[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February 19, 2014, and replaces the 2000 draft guidance for industry on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]
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