Notice2022-18516
Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development; International Council for Harmonisation; Draft Guidances for Industry; Availability
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Published
August 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances for industry entitled "Q2(R2) Validation of Analytical Procedures" and "Q14 Analytical Procedure Development." These draft guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. These draft guidances harmonize scientific approaches for analytical procedure development and include validation of a wider range of analytical techniques. The draft guidances are intended to facilitate regulatory evaluations and facilitate potential flexibility in postapproval change management of analytical procedures. The draft Q2(R2) guidance revises the ICH guidance for industry "Q2(R1) Validation of Analytical Procedures: Text and Methodology" published in November 2005.
Full Text
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<title>Federal Register, Volume 87 Issue 166 (Monday, August 29, 2022)</title>
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[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52784-52786]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18516]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1503]
Q2(R2) Validation of Analytical Procedures and Q14 Analytical
Procedure Development; International Council for Harmonisation; Draft
Guidances for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of two draft guidances for industry entitled ``Q2(R2)
Validation of Analytical Procedures'' and ``Q14 Analytical Procedure
Development.'' These draft guidances were prepared under the auspices
of the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH), formerly the
International Conference on Harmonisation. These draft guidances
harmonize scientific approaches for analytical procedure development
and include validation of a wider range of analytical techniques. The
draft guidances are intended to facilitate regulatory evaluations and
facilitate potential flexibility in postapproval change management of
analytical procedures. The draft Q2(R2) guidance revises the ICH
guidance for industry ``Q2(R1) Validation of Analytical Procedures:
Text and Methodology'' published in November 2005.
DATES: Submit either electronic or written comments on the draft
guidance by September 28, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[[Page 52785]]
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-D-1503 for ``Q2(R2) Validation of Analytical Procedures'' and
``Q14 Analytical Procedure Development.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or 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 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: David Keire, Center for Drug Evaluation and
Research, Food and Drug Administration, 645 S Newstead Ave., Rm. 2008,
St. Louis, MO 63110-1116, <a href="/cdn-cgi/l/email-protection#9dd9fcebf4f9b3d6f8f4eff8ddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="074366716e63294c626e756247616366296f6f7429606871">[email protected]</span></a>.
Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#1b51727777355a7f777e797e697c5b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="c18ba8adadef80a5ada4a3a4b3a681a7a5a0efa9a9b2efa6aeb7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of two draft guidances for
industry entitled ``Q2(R2) Validation of Analytical Procedures'' and
``Q14 Analytical Procedure Development.'' The draft guidances were
prepared under the auspices of ICH. ICH has the mission of achieving
greater regulatory harmonization worldwide to ensure that safe,
effective, high-quality medicines are developed, registered, and
maintained in the most resource-efficient manner.
By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
The six Founding Members of the ICH are the FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to <a href="https://www.ich.org/">https://www.ich.org/</a>).
ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
In March 2022, the ICH Assembly endorsed the draft guidelines
entitled ``Q2(R2) Validation of Analytical Procedures'' and ``Q14
Analytical Procedure Development'' and agreed that the guidelines
should be made available for public comment. The draft guidelines are
the product of the Quality Expert Working Group of the ICH. Comments
about these draft guidances will be considered by FDA and the Quality
Expert Working Group.
The draft Q2(R2) guideline revises the Q2(R1) guideline published
in 2005 to cover a broader range of analytical
[[Page 52786]]
procedures, including those used for process control and that apply to
multivariate methods. The draft Q14 guideline harmonizes scientific
approaches for analytical procedure development and describes
principles to facilitate more efficient and science-based and risk-
based postapproval change management. The two guidelines are intended
to facilitate regulatory evaluations and facilitate potential
flexibility in postapproval change management of analytical procedures
where scientifically justified.
These draft guidances have been left in the original ICH format.
The final guidances will be reformatted and edited to conform with
FDA's good guidance practices regulation (21 CFR 10.115) and style
before publication. The draft guidances, when finalized, will represent
the current thinking of FDA on the topics they address. They do not
establish any rights for any person and are 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. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for investigational new drug applications have been
approved under OMB control number 0910-0014; the collections of
information for review of new drug applications have been approved
under OMB control number 0910-0001; and the collections of information
for review of biologics license applications have been approved under
OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft guidances
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>.
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18516 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P
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