Notice2025-06968
Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
Primary source
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Published
April 23, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments' quality management practices, and to provide useful feedback to participants. This notice announces CDER's intent to continue the voluntary 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.
Full Text
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<title>Federal Register, Volume 90 Issue 77 (Wednesday, April 23, 2025)</title>
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[Federal Register Volume 90, Number 77 (Wednesday, April 23, 2025)]
[Notices]
[Pages 17069-17071]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06968]
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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.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for a limited number of drug manufacturing
establishments to participate in the second year of the voluntary
Quality Management Maturity Prototype Assessment Protocol Evaluation
Program involving the use of a refined prototype assessment protocol to
evaluate quality management maturity (QMM). The Center of Drug
Evaluation and Research (CDER) implemented this voluntary program for
manufacturers of CDER-regulated drug products to gain additional
experience with, and further refine as necessary, the prototype
assessment protocol and process, to help enable consistent and
meaningful assessment of participating establishments' quality
management practices, and to provide useful feedback to participants.
This notice announces CDER's intent to continue the voluntary QMM
Prototype Assessment Protocol Evaluation
[[Page 17070]]
Program, outlines the types of establishments CDER is seeking for
participation, and describes the process for submitting a request to
participate in the program.
DATES: CDER intends to accept requests to participate in the voluntary
QMM Prototype Assessment Protocol Evaluation Program through June 9,
2025. See the ``Participation'' section of this document for
instructions on submitting a request to participate and the selection
process.
FOR FURTHER INFORMATION CONTACT: For questions about the voluntary QMM
Prototype Assessment Protocol Evaluation Program: 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#f4b7b0b1a6d9a5b9b9b4929095da9c9c87da939b82"><span class="__cf_email__" data-cfemail="2b686f6e79067a66666b4d4f4a05434358054c445d">[email protected]</span></a>. To submit a request to
participate in the program: Conchetta Newton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4144, 240-402-6551, <a href="/cdn-cgi/l/email-protection#9fdcdbdacdb2ced2d2dff9fbfeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="bdfef9f8ef90ecf0f0fddbd9dc93d5d5ce93dad2cb">[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
is in the process of developing a voluntary program to promote QMM at
drug manufacturing establishments, which would encourage drug
manufacturers to implement or improve their quality management
practices.\1\
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\1\ In 2023, CDER solicited comments to inform the development
of a future QMM program. Then, in 2024, CDER initiated a voluntary
QMM Prototype Assessment Protocol Evaluation Program. See 88 FR
63587, September 15, 2023, and 89 FR 4950, January 25, 2024,
respectively.
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Between October 2020 and March 2022, CDER conducted two pilot
programs to assess the QMM of drug manufacturing establishments. The
first pilot program evaluated the maturity of seven domestic
manufacturers of finished dosage forms for the U.S. market.\2\ The
second pilot program evaluated the maturity of eight foreign
manufacturers of active pharmaceutical ingredients (APIs).\3\ Each
pilot program was conducted by a different contractor. These pilot
programs provided valuable insights for CDER to develop a protocol to
assess establishments' QMM, understand assessor behaviors during
interviews of establishment personnel, and gather participant feedback
on assessment questions, reports, and outcomes.\4\
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\2\ Quality Management Maturity for Finished Dosage Forms Pilot
Program for Domestic Drug Product Manufacturers; Program
Announcement, 85 FR 65824, October 16, 2020, <a href="https://www.federalregister.gov/d/2020-22976">https://www.federalregister.gov/d/2020-22976</a>.
\3\ Quality Management Maturity for Active Pharmaceutical
Ingredients Pilot Program for Foreign Facilities; Program
Announcement, 85 FR 65828, October 16, 2020, <a href="https://www.federalregister.gov/d/2020-22977">https://www.federalregister.gov/d/2020-22977</a>.
\4\ Maguire, J., A. Fisher, D. Harouaka, et al., ``Lessons from
CDER's Quality Management Maturity Pilot Programs,'' AAPS J, 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>.
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Using the findings from these two pilot programs, a review of the
literature on quality management, evaluations of existing external
programs assessing elements of quality culture or pharmaceutical
quality, surveys of external stakeholders, and feedback from partner
offices and centers within FDA, CDER developed a prototype assessment
protocol to evaluate an establishment's QMM.\5\ This prototype
assessment protocol included a series of questions in five practice
areas: management commitment to quality,\6\ business continuity,
technical excellence, advanced pharmaceutical quality system, and
employee empowerment and engagement. Within each practice area, the
prototype assessment protocol explores key elements of the
establishment's QMM. Examples of some topics covered under the practice
areas include management review and resource management (management
commitment to quality), supply planning and demand forecasting
(business continuity), continual improvement \7\ (advanced
pharmaceutical quality system), data governance and process
optimization (technical excellence), and rewards and recognition
(employee engagement and empowerment).
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\5\ 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">https://www.fda.gov/media/171705/download</a>.
\6\ Note that this practice area was previously referred to as
`leadership' (89 FR 4950 at 4951). We have since modified this to
``management commitment to quality'' to align with what the practice
area was titled at the time that specific prototype was developed
and as discussed in our 2023 QMM white paper: CDER's Quality
Management
Maturity (QMM) Program: Practice Areas and Prototype Assessment
Protocol Development (see <a href="https://www.fda.gov/media/171705/download">https://www.fda.gov/media/171705/download</a>). ``Management Commitment to Quality'' more accurately
reflects the topic areas covered in this practice area.
\7\ Note that the example in the previous Federal Register
Notice (89 FR 4950 at 4951) was ``corrective action and preventive
action process'' (89 FR 4950 at 4951). That has since been replaced
with ``Continual improvement'' as an example to align with
modifications that were made to the prototype assessment protocol.
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In 2024, CDER evaluated nine establishments in the voluntary QMM
Prototype Assessment Protocol Evaluation Program.\8\ CDER used the
prototype assessment protocol to collect information on each
establishment's practices, behaviors, and responses to specific
questions in five practice areas. The information collected was
evaluated using an objective rubric. Trained assessors conducted 5-day
assessments and provided establishments with a QMM report following the
assessment. Each QMM report highlighted the establishment's strengths
and opportunities for improvement. Feedback from voluntary participants
indicated that engagement with the QMM assessment team and the QMM
reports were favorably received and provided value to the
establishments. However, participants also indicated that certain
aspects of the prototype assessment protocol were repetitive and
suggested that the protocol should be streamlined.
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\8\ See 89 FR 4950, January 25, 2024.
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The 2024 QMM Prototype Assessment Protocol Evaluation Program
provided CDER with experience in the successful application of the
prototype assessment tool across a group of volunteer establishments
that reasonably reflected the diversity of the industry. The rubric
effectively differentiated the maturity of quality management practices
across the nine establishments assessed in 2024. Using the feedback
received and insights gained from 2024, CDER modified its prototype QMM
assessment tool to be clearer and more concise and updated the rubric.
We also modified how some of the questions are framed for greater
clarity. CDER intends to evaluate these improvements and further refine
the prototype protocol as necessary by continuing the voluntary program
and offering the opportunity to establishments that wish to volunteer
to participate in 2025. This notice announces CDER's intent to continue
the voluntary 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.
[[Page 17071]]
II. Participation
A. Establishment Characteristics
CDER will consider the following establishment characteristics when
identifying potential participants for this voluntary 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 has received at least one human drug
surveillance inspection.\9\
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\9\ Inspections conducted by FDA or by Mutual Recognition
Agreement partners and classified by FDA fulfill this criterion. We
also updated the original characteristic (``The establishment has
received at least one human drug surveillance inspection in the
prior 5 years,'' as published in 89 FR 4950 at 4951) to remove the
5-year timeframe and expand the number of potential establishments
that could be eligible to participate.
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<bullet> The current inspection classification for the
establishment at the time of the request to participate is No Action
Indicated or Voluntary Action Indicated.
<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 United States.
<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) FDA Establishment Identifier and Data Universal Numbering
System Numbers.
(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 you produce APIs, generic drugs, innovator
drugs, OTC drugs, biological drug products, and if you are a contract
manufacturing or contract testing organization.
(5) Confirmation that the establishment features the
characteristics discussed in Section II.A of this notice.
To be eligible to participate in this 2025 program, establishments
should submit a request to participate within the request acceptance
period as discussed in the DATES section. This applies to all
establishments regardless of whether they previously submitted a
request to participate in the 2024 QMM Prototype Assessment Protocol
Evaluation Program.
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 45 days after the
close of the request acceptance period as discussed in the DATES
section when this notice closes. CDER intends to select up to nine
volunteer participants for this program.
D. CDER-Participant Interactions
CDER intends to notify participants of their selection and confirm
participation. This notification would include information about a
virtual orientation session in which CDER would share additional
information with participating establishments including the program
timelines, milestones, and expectations. Participating establishments
would also receive a pre-assessment questionnaire, which provides
specific topic areas that would be addressed during the assessment,
help to prepare in advance of the assessment, and help determine which
personnel would be most appropriate to provide supporting information.
CDER intends to provide each establishment with options for dates to
schedule the 5-day assessment.
Teams of three assessors would conduct each assessment. The QMM
assessment team would be composed of CDER staff not including personnel
from FDA's Office of Inspections and Investigations charged with the
responsibility of ensuring compliance with current good manufacturing
practice. In advance of the assessment, the establishment would receive
an agenda to ensure the appropriate people are present at the requested
times. The entire leadership team would not need to be present for the
full assessment. If necessary, personnel may participate remotely.
Following completion of the assessment, each participating
establishment would receive a report that provides, for each practice
area: their score, a narrative, areas of strength, and opportunities
for improvement. After reviewing the report, participating
establishments would meet with the QMM assessment team to discuss any
questions or comments they have regarding the report.
In the post-assessment phase of this program, participating
establishments will be encouraged to select at least one opportunity to
improve from the QMM report and develop an improvement plan with
defined goal(s) based on that opportunity. Approximately 3 months after
receipt of the QMM report, participating establishments will share
their improvement plan with CDER and meet to discuss their plan and
path forward. Approximately 6 months after receipt of the QMM report,
CDER will schedule a final meeting with the participating establishment
to discuss any progress made toward achieving their improvement
goal(s). CDER will also solicit feedback from each participating
establishment on the assessment, the report, and any suggestions or
input they wish to share. This information will help CDER evaluate use
of its QMM assessment tool and process to determine whether it enables
a meaningful assessment of the establishment's quality management
practices and if the feedback provided to the establishment was useful.
Dated: April 16, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-06968 Filed 4-22-25; 8:45 am]
BILLING CODE 4164-01-P
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