Notice2023-20015
Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments
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Published
September 15, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments that will assist the Agency in developing a Quality Management Maturity (QMM) program for establishments manufacturing human drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER).
Full Text
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<title>Federal Register, Volume 88 Issue 178 (Friday, September 15, 2023)</title>
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[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63587-63589]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20015]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3721]
Quality Management Maturity Program for Drug Manufacturing
Establishments; Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of establishment of a public docket; request for
comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a docket to solicit comments that will assist the
Agency in developing a Quality Management Maturity (QMM) program for
establishments manufacturing human drugs, including biological
products, regulated by the Center for Drug Evaluation and Research
(CDER).
DATES: Submit either electronic or written comments on the notice by
December 14, 2023 to ensure that the Agency considers your comment.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments may not be considered. Electronic comments must
be submitted on or before December 14, 2023. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 14, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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-2023-N-3721 for ``Quality Management Maturity Program for Drug
Manufacturing Establishments; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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
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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.
FOR FURTHER INFORMATION CONTACT: Djamila Harouaka, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4160, Silver Spring, MD 20993-0002, 240-
402-0224, <a href="/cdn-cgi/l/email-protection#0c4f48495e215d41414c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="95d6d1d0c7b8c4d8d8d5f3f1f4bbfdfde6bbf2fae3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Drug manufacturers can achieve higher levels of QMM by successfully
integrating business and manufacturing operations with quality
practices and technological advancements to optimize manufacturing
process performance and product quality, enhance supply chain
reliability, and foster proactive continual improvement. CDER is
developing a voluntary program to promote QMM at drug manufacturing
establishments. The goals of this program are: (1) to foster a strong
quality culture mindset; (2) recognize establishments that have
advanced quality management practices and acknowledge establishments
that strive to continually improve those practices; (3) identify areas
where quality management practices can be enhanced and provide
suggestions for growth opportunities; and (4) minimize risks to product
availability to assure reliable market supply.
The QMM assessment is designed to appraise an establishment's
quality culture mindset, behaviors, and commitment to adopting best
practices to effectively meet the needs of patients and consumers. QMM
assessments would not be used to evaluate compliance with current good
manufacturing practice (CGMP).
QMM assessments would be conducted by trained assessors, who would
engage directly with establishments, either onsite or in a hybrid
(onsite/remote) environment, for 2 to 5 business days. The QMM
assessment will cover five practice areas: (1) management commitment to
quality; (2) business continuity; (3) advanced pharmaceutical quality
system; (4) technical excellence; and (5) employee engagement and
empowerment. Within each practice area, the assessors would explore key
elements to better understand an establishment's QMM. Examples of
elements covered under each practice area could include: management
review and resource management (management commitment to quality
practice area), supply planning and demand forecasting (business
continuity practice area), data governance and process optimization
(technical excellence practice area), effectiveness of the corrective
action and preventive action process (advanced pharmaceutical quality
system practice area), and rewards and recognition (employee engagement
practice area). Each establishment's responses, executed practices, and
behaviors would be assessed using a standardized assessment protocol
and an objective rubric, which is currently under development, to help
identify areas of strength and potential areas with opportunities for
improvement.
At a November 2, 2022, meeting of the Pharmaceutical Science and
Clinical Pharmacology Advisory Committee, FDA sought to determine the
support of academic and industry experts for CDER's development of a
QMM program. By a vote of 9-0, the committee affirmed that CDER should
establish a QMM program to incentivize investments in mature quality
management practices . During deliberations, committee members advised
the Agency to continue to seek stakeholder input throughout the
program's development. Further information about the November 2022
Advisory Committee meeting, including event materials, is available on
FDA's website at <a href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-2-3-2022-pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting">https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-2-3-2022-pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting</a>. For further
information about QMM, relevant research, and previously conducted
pilot programs, please see CDER's QMM web page at <a href="https://www.fda.gov/drugs/pharmaceutical-quality-resources/cder-quality-management-maturity">https://www.fda.gov/drugs/pharmaceutical-quality-resources/cder-quality-management-maturity</a>. FDA has verified the website addresses, as of the date this
document publishes in the Federal Register, but websites are subject to
change over time.
II. Request for Comments
FDA is opening a docket to solicit additional feedback from the
public on CDER's planned, voluntary QMM program. The public is invited
to provide detailed comments on all aspects described in this notice.
To facilitate this input, FDA has developed a list of questions. These
questions are not exhaustive, and FDA welcomes other pertinent
information the public would like to share on this topic. In all cases,
FDA encourages the public to provide the reasoning and specific basis
for any comments.
1. If you are a manufacturer, please identify the types of drug(s)
produced in your establishment (e.g., active pharmaceutical
ingredients, innovator drugs, innovator biologics, generics,
biosimilars, or OTC monograph drugs). If you are not a manufacturer,
please specify whether you are a purchaser, payor, pharmacy, healthcare
provider, patient, regulator, supplier, distributor, contract service
provider, or other (please describe).
2. What advantages do you anticipate that your sector (i.e., your
organization and others like yours) would gain from CDER's voluntary
QMM program?
3. How would participation in a QMM program benefit you or your
specific organization?
4. How would you use information from a QMM assessment if it were
provided to your organization? For example, if your organization acts
as a supplier or contract organization, would you consider sharing
information from a QMM assessment with a potential client? If your
organization enters into contracts with purchasers, would you consider
sharing information from a QMM assessment with a purchaser? If your
organization is a purchaser, would you consider requesting information
from a QMM assessment?
5. What, if any, unintended consequences, roadblocks, or other
concerns do you anticipate with a voluntary QMM program? What barriers
to participation do you anticipate? Please explain. Which of these
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unintended consequences might be unique to stakeholders like you? Why?
6. FDA anticipates that each establishment would be provided with a
detailed report following their QMM assessment. What would you want
such a report to contain?
7. With respect to the outcomes of a QMM assessment, what are your
thoughts about making outcomes public? Would your thoughts be different
if the outcomes were generally qualitative (e.g., descriptive
information) versus quantitative (e.g., a numerical rating)?
8. What other feedback would you like the FDA to consider for a
voluntary QMM program?
III. References
The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a> as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Maguire, J., A. Fisher, D. Harouaka, N. Rakala, et al., 2023,
``Lessons from CDER's Quality Management Maturity Pilot Programs,''
The AAPS Journal, 25(14), January 10, 2023, <a href="https://doi.org/10.1208/s12248-022-00777-z">https://doi.org/10.1208/s12248-022-00777-z</a>.
2. Fellows, M., T. Friedli, Y. Li, J. Maguire, et al., 2022,
``Benchmarking the Quality Practices of Global Pharmaceutical
Manufacturing to Advance Supply Chain Resilience,'' The AAPS
Journal, 24(111), October 20, 2022, <a href="https://doi.org/10.1208/s12248-022-00761-7">https://doi.org/10.1208/s12248-022-00761-7</a>.
Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20015 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P
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