Notice2026-02768
Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the third year of the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with the assessment tool and process. The continuation of this voluntary program is needed to assure that these assessments enable consistent and meaningful evaluations of establishments' quality management practices and provide useful feedback for the establishments. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 28 (Wednesday, February 11, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 28 (Wednesday, February 11, 2026)]
[Notices]
[Pages 6229-6231]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02768]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5706]
Voluntary Quality Management Maturity Prototype Assessment
Protocol Evaluation Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for a limited number of drug manufacturing establishments
to participate in the third year of the voluntary Quality Management
Maturity (QMM) Prototype Assessment Protocol Evaluation Program. The
Center for Drug Evaluation and Research (CDER) is implementing this
voluntary program for manufacturers of CDER-regulated drug products to
gain additional experience with the assessment tool and process. The
continuation of this voluntary program is needed to assure that these
assessments enable consistent and meaningful evaluations of
establishments' quality management practices and provide useful
feedback for the establishments. This notice outlines the types of
establishments FDA is seeking for participation and the process for
submitting a request to participate in the program.
DATES: FDA intends to accept requests to participate in the voluntary
QMM Prototype Assessment Protocol Evaluation Program through April 13,
2026. See the ``Participation'' section of this document for
instructions on submitting a request to participate and for information
about the selection process.
[[Page 6230]]
FOR FURTHER INFORMATION CONTACT: For questions about the voluntary QMM
Prototype Assessment Protocol Evaluation Program, 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#1e5d5a5b4c334f53535e787a7f3076766d30797168"><span class="__cf_email__" data-cfemail="91d2d5d4c3bcc0dcdcd1f7f5f0bff9f9e2bff6fee7">[email protected]</span></a>. To submit a
request to participate in the program, contact Conchetta Newton, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Building 51, Rm. 4144, 240-402-6551, <a href="/cdn-cgi/l/email-protection#6f2c2b2a3d423e22222f090b0e4107071c41080019"><span class="__cf_email__" data-cfemail="397a7d7c6b14687474795f5d581751514a175e564f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
QMM refers to the extent to which drug manufacturing establishments
implement quality management practices that prioritize patients, drive
continual improvement, and enhance supply chain reliability through the
strategic integration of business decisions and manufacturing
operations with quality practices and technological advancements. CDER
has developed a voluntary QMM program to encourage drug manufacturers
to implement quality management practices that go beyond current good
manufacturing practice (CGMP) requirements.\1\
---------------------------------------------------------------------------
\1\ FDA has solicited comments to inform the development of this
program. See 88 FR 63587, September 15, 2023.
---------------------------------------------------------------------------
Following completion of the first year of the program, CDER refined
the prototype QMM assessment tool (including both a protocol and
rubric), which is used to evaluate how effectively establishments
monitor and manage quality and quality systems.\2\ In CY 2026, CDER
intends to continue the voluntary QMM Prototype Assessment Protocol
Evaluation Program to evaluate a drug manufacturing establishment's
quality management practices and provide actionable feedback for the
establishment. This notice announces CDER's intent to continue the QMM
Prototype Assessment Protocol Evaluation Program, outlines the types of
establishments CDER is seeking for participation, and describes the
process for submitting a request to participate in the program.
---------------------------------------------------------------------------
\2\ For additional information, see CDER's Quality Management
Maturity (QMM) Program: Practice Areas and Prototype Assessment
Protocol Development (2023), available at <a href="https://www.fda.gov/media/171705/download?attachment">https://www.fda.gov/media/171705/download?attachment</a>.
---------------------------------------------------------------------------
In 2024, CDER evaluated nine establishments during the initial year
of the voluntary QMM Prototype Assessment Protocol Evaluation
Program.\3\ CDER used a standardized prototype assessment protocol and
rubric to evaluate each establishment's practices, behaviors, and
responses to specific questions. Feedback from participants in the
first year of the program indicated that the QMM report, engagement
with the assessment team, and the ability to have open discussions
provided value to establishments and highlighted strengths and
opportunities for improvement. In addition, participating
establishments were able to share challenges and successes related to
their manufacturing sectors.
---------------------------------------------------------------------------
\3\ See 89 FR 4950, January 25, 2024.
---------------------------------------------------------------------------
The 2024 QMM program provided CDER with experience in the
successful application of the standardized prototype assessment
protocol and rubric at nine drug manufacturing establishments. The nine
establishments represented a range of manufacturing sectors (e.g.,
generic drug manufacturers, contract testing laboratory, brand drug
manufacturers) in the pharmaceutical industry. The prototype assessment
protocol and rubric distinguished differences in maturity levels
between practice areas at a single establishment. Differences in
maturity levels were also clearly discerned between establishments.
Using the insights gained from these experiences, CDER streamlined the
QMM assessment tool to make the prototype protocol and rubric clearer
and more concise.
CDER is now evaluating the refined assessment tool at more
establishments in the second year of the QMM Prototype Assessment
Protocol Evaluation Program, which is ongoing. Through this
announcement, CDER is offering an opportunity for additional
establishments to volunteer to participate. This will allow CDER to
gain further experience with the assessment tool, expand our knowledge
of quality management practices in the industry, and provide additional
drug manufacturing establishments with actionable feedback.
II. Participation
A. Establishment Characteristics
CDER will consider the following establishment characteristics when
identifying potential participants for the third year of the QMM
Prototype Assessment Protocol Evaluation Program:
<bullet> The potential participant is an establishment as defined
in 21 CFR 207.1 that registers with FDA under section 510 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and manufactures,
prepares, propagates, compounds, or processes drugs, or APIs used in
such drugs, subject to approval or licensure under section 505 of the
FD&C Act or section 351 of the Public Health Service Act, or that are
marketed pursuant to section 505G of the FD&C Act without an approved
application under section 505 of the FD&C Act (often referred to as
over-the-counter (OTC) monograph drug products).
<bullet> The establishment received at least one human drug
surveillance inspection.\4\
---------------------------------------------------------------------------
\4\ Inspections conducted by FDA or by Mutual Recognition
Agreement (MRA) partners and classified by FDA would fulfill this
criterion.
---------------------------------------------------------------------------
<bullet> The current inspection classification for the
establishment at the time of the request to participate is No Action
Indicated (NAI) or Voluntary Action Indicated (VAI).
<bullet> The establishment manufactures, prepares, propagates,
compounds, or processes at least one CDER-regulated drug (API or
finished drug product) that is currently in commercial distribution in
the U.S.
<bullet> The establishment is willing to participate in an onsite
or hybrid assessment.
B. Requests To Participate
Drug product manufacturers that meet the establishment
characteristics described in section II.A and are interested in
participating in the voluntary QMM Prototype Assessment Protocol
Evaluation Program should submit a request directly to Conchetta Newton
(see FOR FURTHER INFORMATION CONTACT). To be considered for this
program, a request should include all the following information:
(1) A contact person (name and email).
(2) Manufacturing establishment address.
(3) Establishment FDA Establishment Identifier (FEI) and Data
Universal Numbering System Numbers (DUNS).
(4) A brief description of the business operations (e.g.,
manufacturing, testing, re/packaging, re/labeling, sterilizing,
storing, distributing, or salvaging) conducted at the establishment.
Please indicate whether the establishment produces active
pharmaceutical ingredients (APIs), generic drugs, innovator drugs,
over-the-counter (OTC) drugs, biological drug products, and if the
establishment is a contract manufacturing or contract testing
organization.
(5) Confirmation that the establishment features the
characteristics discussed in section II.A of this notice.
[[Page 6231]]
C. Selection Process
CDER intends to select participants that reasonably reflect the
diversity of the industry. CDER intends to notify each establishment of
a decision on their request to participate within 60 days of receipt.
CDER intends to select up to nine volunteer participants for this
program.
D. FDA-Participant Interactions
CDER intends to notify participants of their selection and confirm
their willingness to participate. Selected participants will receive
orientation materials which will contain additional information about
program timelines, milestones, and expectations. Participating
establishments will also receive a pre-assessment questionnaire, which
will provide them with specific topic areas that will be covered during
the assessment. The pre-assessment questionnaire is intended to help
establishments prepare for the assessment and identify the relevant
subject matter experts to support the assessment. CDER will also
provide each establishment with options for dates and times to schedule
the assessment which may take up to five days.
Each assessment will be conducted by a team of three assessors. The
assessment team will be composed of CDER staff and will not include FDA
personnel from the Office of Inspections and Investigations charged
with the responsibility of ensuring CGMP compliance. In advance of the
assessment, the establishment will receive an agenda so that they can
assure the appropriate subject matter experts are available at the
requested times. The entire leadership team does not need to be present
for the full assessment. If necessary, personnel may participate
remotely as the establishment deems appropriate.
Following completion of the assessment, each participating
establishment will receive a QMM assessment report that provides their
score in each practice area and underlying topics covered along with
context for how the score was determined. The report will highlight 2-3
areas of strength and 2-3 actionable opportunities for improvement in
each practice area. Participating establishments are encouraged to
select at least one opportunity for improvement identified in the QMM
assessment report and develop a plan to implement improvement(s).
Establishments are requested to share their improvement plan with CDER,
and a meeting will be scheduled to discuss the proposed plan 3 months
after the assessment. Approximately 6 months after the assessment, CDER
will schedule a final check-in meeting to discuss any progress made
toward the improvement goals. CDER will solicit feedback from each
establishment on the assessment, the QMM assessment report, and invites
any suggestions or input to improve the program. This information will
help CDER evaluate the QMM assessment tool and process to determine
whether it enables a meaningful assessment of the establishment's
quality management practices and if feedback for the establishment is
actionable.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-02768 Filed 2-10-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 11, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.