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Notice2022-12919

Q9(R1) Quality Risk Management; International Council for Harmonisation; Draft Guidance for Industry; Availability

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Published
June 15, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Q9(R1) Quality Risk Management." The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The current Q9 guideline published in 2006 provides a common, harmonized framework for Quality Risk Management (QRM) that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. This draft guidance is a targeted revision that addresses four areas for improvement, including high levels of subjectivity in risk assessments and in QRM outputs; product availability risks; lack of understanding as to what constitutes formality in QRM work; and lack of clarity on risk-based decision-making. The revisions are intended to update the original Q9 guideline based on implementation experience to promote improved lifecycle management of hazards and prevent defects, recalls, and shortages.

Full Text

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<title>Federal Register, Volume 87 Issue 115 (Wednesday, June 15, 2022)</title>
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[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Notices]
[Pages 36135-36137]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12919]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0705]


Q9(R1) Quality Risk Management; International Council for 
Harmonisation; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Q9(R1) 
Quality Risk Management.'' The draft guidance was prepared under the 
auspices of the International Council for Harmonisation (ICH), formerly 
the International Conference on Harmonisation. The current Q9 guideline 
published in 2006 provides a common, harmonized framework for Quality 
Risk Management (QRM) that can enable more effective and consistent 
risk-based decisions, both by regulators and industry, regarding the 
quality of drug substances and drug products across the product 
lifecycle. This draft guidance is a targeted revision that addresses 
four areas for improvement, including high levels of subjectivity in 
risk assessments and in QRM outputs; product availability risks; lack 
of understanding as to what constitutes formality in QRM work; and lack 
of clarity on risk-based decision-making. The revisions are intended to 
update the original Q9 guideline based on implementation experience to 
promote improved lifecycle management of hazards and prevent defects, 
recalls, and shortages.

DATES: Submit either electronic or written comments on the draft 
guidance by July 15, 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>.
    <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-0705 for ``Q9(R1) Quality Risk Management.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' are 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

[[Page 36136]]

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 
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, or 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. 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: Rick Friedman, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 51, Rm. 4348, Silver Spring, MD 20993-
0002, 301-796-3268, <a href="/cdn-cgi/l/email-protection#6a38030901442c18030f0e070b042a0c0e0b44020219440d051c"><span class="__cf_email__" data-cfemail="80d2e9e3ebaec6f2e9e5e4ede1eec0e6e4e1aee8e8f3aee7eff6">[email&#160;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, 301-796-5259, 
<a href="/cdn-cgi/l/email-protection#9ed4f7f2f2b0dffaf2fbfcfbecf9def8faffb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="054f6c69692b4461696067607762456361642b6d6d762b626a73">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Q9(R1) Quality Risk Management.'' The guidance was 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 November 2021, the ICH Assembly endorsed the draft guideline 
entitled ``Q9(R1) Quality Risk Management'' and agreed that the 
guideline should be made available for public comment. The draft 
guideline is the product of the Quality Expert Working Group of the 
ICH. Comments about this draft guidance will be considered by FDA and 
the Quality Expert Working Group.
    FDA is thus announcing the availability of a guidance for industry 
entitled ``Q9(R1) Quality Risk Management.'' The current Q9 guideline 
published in 2006 provides a common, harmonized framework for Quality 
Risk Management that can enable more effective and consistent risk-
based decisions, both by regulators and industry, regarding the quality 
of drug substances and drug products across the product lifecycle. This 
draft guidance is a targeted revision that addresses four areas for 
improvement: (1) high levels of subjectivity in risk assessments and in 
QRM outputs; (2) product availability risks; (3) lack of understanding 
as to what constitutes formality in QRM work; and (4) lack of clarity 
on risk-based decision-making. The revisions are intended to update the 
original Q9 guideline based on implementation experience to promote 
improved lifecycle management of hazards and prevent defects, recalls, 
and shortages.
    This draft guidance has been left in the original ICH format. The 
final guidance will be reformatted and edited to conform with FDA's 
good guidance practices regulation (21 CFR 10.115) and style before 
publication. The draft guidance, when finalized, will represent the 
current thinking of FDA on ``Q9(R1) Quality Risk Management.'' 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. 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

[[Page 36137]]

Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not required for this 
guidance. The previously approved collections of information are 
subject to review by OMB under the PRA. The collection of information 
in 21 CFR part 211 has been approved under OMB control number 0910-
0139.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at <a href="https://www.regulations.gov">https://www.regulations.gov</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>, or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.

    Dated: June 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12919 Filed 6-14-22; 8:45 am]
BILLING CODE 4164-01-P


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